Cagrilintide: CagriSema trial results, the doses and titration used, side effects and where approval stands
What 105 indexed publications and 15 randomized trials actually state about cagrilintide, sentence by sentence, each tied to its source and labeled by the kind of evidence it is.
At a glance
What cagrilintide is and how it acts
Cagrilintide is a peptide in the incretin & amylin analogs class (long-acting amylin analog). Europe PMC indexes 105 publications naming it or a listed alias in a title or abstract, including 15 randomized controlled trials and 13 clinical trials of any design, as of . The strongest evidence tier in that literature is human clinical trials.
This page reports what those studies state, sentence by sentence, with each statement tied to its source and labeled by the kind of evidence it is. It does not recommend use, and it does not translate study doses into anything personal.
What the evidence level means
Publication counts show what is indexed, not how strong the evidence is. The ledger below separates human clinical records from preclinical, analytical, and in-vitro work.
Interpretation boundary: An indexed publication count is a discovery measure. It does not establish efficacy, safety, approval, or a personal treatment plan.
Cagrilintide in two minutes
What it is. A once-weekly analogue of amylin, the pancreatic hormone that signals fullness, developed by Novo Nordisk. On its own it is a weight-loss drug in phase 3; combined with semaglutide as CagriSema it is the company's next obesity medicine, with phase 3 trials complete and a regulatory submission in progress.
What the research actually shows. Fifteen indexed randomized trials. CagriSema reduced weight by about 20 percent over 68 weeks in adults without diabetes (REDEFINE 1, 3,417 participants) and about 14 percent in adults with type 2 diabetes (REDEFINE 2). Alone, at up to 4.5 mg weekly, about 11 percent over 26 weeks. Gastrointestinal side effects in roughly four of five participants, mostly mild and early; injection-site reactions more common than with semaglutide.
What people commonly report using. Grey-market vials injected weekly, stepped up on the trial schedule to 2.4 mg, alone or with semaglutide. Same pharmacology, unknown product.
Status. Not approved anywhere yet. Not named on the WADA list.
Where the evidence is thinnest. Long-term outcomes; what happens after stopping; the identity of anything sold before approval.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
How cagrilintide works
Written from general pharmacology and the development record, and marked as editorial synthesis; the measurements behind it are quoted in the biomarker section.
- Editorial synthesis from general knowledge
- Editorial synthesis from general knowledge
- Editorial synthesis from general knowledge
What did the trials find?
One row per primary study in this record's ledger. Fields are read from each paper's indexing and abstract. "Analytical method" marks papers about detecting or measuring the compound rather than about its effects.
| Study | Design | n | Species | Dose | Route | Duration | Reported outcome | Tier |
|---|---|---|---|---|---|---|---|---|
| Busetto 2026 | Randomized controlled trial | — | Humans | 2.4 mg | — | — | This secondary, post hoc analysis assessed the proportions of participants achieving BMI 2 and/or WHtR Results The proportion of participants achieving both BMI 2 and WHtR Conclusions The proportion of participants… | Human clinical trial |
| Loomba 2026 | Randomized controlled trial | 99 | Humans | 2·4 mg | subcutaneous | 52 weeks | Similarly, the proportions of participants achieving this endpoint in the two groups that combined lower doses of zalfermin with semaglutide 2·4 mg and in the exploratory group combining cagrilintide 2·4 mg with… | Human clinical trial |
| Yaseen 2026 | Clinical trial | 5,425 | Humans | — | — | — | Cagrilintide monotherapy produced significant reductions in body weight (MD: -6.08%; MD: -5.89 kg) and blood pressure, without meaningful HbA1c improvement. | Human clinical trial |
| Rosenstock 2026 | Randomized controlled trial | 90 | Humans | 2·4 mg; 1·0 mg | subcutaneous | 40 weeks | Mean HbA 1c reductions were significantly greater with cagrilintide-semaglutide (2·4 mg each -2·33% [SE 0·08] and 1·0 mg each -2·10% [0·08]) versus placebo (-0·66% [0·11]) at week 40, using the efficacy estimand… | Human clinical trial |
| Aroda 2026 | Randomized controlled trial | 62 | Humans | 2·4 mg; 1·0 mg | subcutaneous | 18 years; 40 weeks | This corresponded to an estimated treatment difference of -1·7 percentage points (95% CI -2·0 to -1·3; p Interpretation In a population of people with early-stage type 2 diabetes inadequately controlled with diet and… | Human clinical trial |
| Buse 2026 | Randomized controlled trial | 603 | Humans | 2·4 mg; 1·0 mg | subcutaneous | 18 years; 68 weeks | For the primary endpoint using the efficacy estimand, mean HbA 1c change was significantly greater with cagrilintide-semaglutide (2·4 mg each) versus semaglutide 2·4 mg (-1·91 percentage points [SE 0·04] vs -1·75… | Human clinical trial |
| Nielsen 2026 | Randomized controlled trial | 14 | Humans | — | — | — | No increase in number of adverse events with increasing renal or hepatic impairment was observed, and no new safety or tolerability findings with cagrilintide were identified with renal or hepatic impairment. | Human clinical trial |
| Yamauchi 2026 | Randomized controlled trial | 164 | Humans | 2·4 mg | subcutaneous | — | The combination of cagrilintide and semaglutide has been shown in global studies to induce reductions in bodyweight. | Human clinical trial |
| Verma 2026 | Randomized controlled trial | 2,108 | Humans | 2.4 mg | — | — | Among participants who used antihypertensive medication during the study, 39.6% in the CagriSema group decreased or stopped treatment from week 0 to week 68 versus 18.8% with placebo. | Human clinical trial |
| Al-Harbi 2025 | Clinical trial | 5 | Humans | — | — | — | — | Human clinical trial |
| Briere 2025 | Randomized controlled trial | 15 | Humans | — | — | — | Eloralintide induced significantly less conditioned taste avoidance in lean rats than cagrilintide, a non-selective amylin receptor agonist (p 2 . | Human clinical trial |
| Garvey 2025 | Randomized controlled trial | 3,417 | Humans | 2.4 mg | — | — | The estimated mean percent change in body weight from baseline to week 68 was -20.4% with cagrilintide-semaglutide as compared with -3.0% with placebo (estimated difference, -17.3 percentage points; 95% confidence… | Human clinical trial |
| Davies 2025 | Randomized controlled trial | 1,206 | Humans | 2.4 mg | — | 68 weeks | The estimated mean change in body weight from baseline to week 68 was -13.7% in the cagrilintide-semaglutide group and -3.4% in the placebo group (estimated difference, -10.4 percentage points; 95% confidence interval,… | Human clinical trial |
| Gabe 2024 | Randomized controlled trial | 53 | Humans | — | subcutaneous | — | Cagrilintide did not result in clinically relevant QTcF prolongation, indicating no increased risk of ventricular tachyarrhythmias. | Human clinical trial |
| Frias 2023 | Randomized controlled trial | 31 | Humans | 2·4 mg | subcutaneous | — | The mean change in HbA 1c from baseline to week 32 (CagriSema: -2·2 percentage points [SE 0·15]; semaglutide: -1·8 percentage points [0·16]; cagrilintide: -0·9 percentage points [0·15]) was greater with CagriSema… | Human clinical trial |
| Lau 2021 | Randomized controlled trial | 73 | Humans | 0·3-4·5 mg; 3·0 mg | subcutaneous | 26 week; 6 weeks | According to the trial product estimand, mean percentage weight reductions from baseline were greater with all doses of cagrilintide (0·3-4·5 mg, 6·0%-10·8% [6·4-11·5 kg]) versus placebo (3·0% [3·3 kg]; estimated… | Human clinical trial |
| Enebo 2021 | Randomized controlled trial | 12 | Humans | 0·16-2·4 mg; 0·60 mg | subcutaneous | 4 week; 16 weeks | Exposure was proportional to cagrilintide dose and did not affect semaglutide exposure or elimination. | Human clinical trial |
| Ludwig 2026 | Animal study | — | Rats, Mice | — | — | — | — | Animal, preclinical |
| Old 2026 | Animal study | — | Mice | — | — | 5 days | In healthy myotubes, semaglutide and cagrilintide transiently reduced basal respiration (↓21%-28%, p Conclusion Incretin-based therapies exert distinct, time and dose-dependent effects on skeletal muscle mitochondrial… | Animal, preclinical |
| Alhalabi 2026 | Analytical method | — | Rats | — | — | — | — | Animal, preclinical |
| Gu 2026 | Animal study | — | — | — | — | — | Cagrilintide (Cagri), functioning as a dual amylin receptor (AMYRs) and calcitonin receptor (CTR) agonist (DACRA), demonstrates significant efficacy in obesity treatment, although its structural activation mechanism… | Animal, preclinical |
| Jacobsen 2025 | Animal study | — | Rats | — | — | — | Quantifying CagriSema's action on energy intake and expenditure in rats we observe 12% weight loss with a 39% reduction in food intake. | Animal, preclinical |
| Carvas 2025 | Animal study | — | Mice | — | subcutaneous | 23 weeks; 3 week | Body weight loss was observed in WT cagrilintide-treated mice (-3.4 ± 0.51 g, P Interpretation Altogether, these results demonstrate the dependency of cagrilintide on AMY 1 R and AMY 3 R to lower body weight. | Animal, preclinical |
| Cao 2025 | Animal study | — | Rats | — | — | — | — | Animal, preclinical |
What doses did the trials use?
These are the doses the manufacturer tested in trials of its own product. They are not a recommendation, and nothing sold as a research chemical has been shown to contain the drug. Each entry is a sentence quoted from the study's abstract, with the study's design, sample size and year in front of it. Comparator doses in the same sentence are not attributed to cagrilintide.
- Doses stated in the abstract: 2.4 mg
The phase 3a, 68-week REDEFINE 1 trial randomised adults without diabetes with BMI ≥ 30 kg/m 2 , or ≥ 27 kg/m 2 with ≥ 1 obesity-related complication, to once-weekly CagriSema 2.4 mg/2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg, or placebo, plus lifestyle intervention.
Sourcepmid-42503495· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2·4 mg
Eligible participants were randomly assigned to receive subcutaneous zalfermin 7·5 mg plus subcutaneous semaglutide 2·4 mg, zalfermin 15 mg plus semaglutide 2·4 mg, zalfermin 30 mg plus semaglutide 2·4 mg, zalfermin 30 mg, semaglutide 2·4 mg, cagrilintide 2·4 mg plus semaglutide 2·4 mg, or placebo only once a week for 52 weeks.
Sourcepmid-42456707· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2·4 mg; 1·0 mg
Adults with type 2 diabetes (glycated haemoglobin [HbA 1c ] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin were randomly assigned (2:2:1:1) to once per week subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (hereafter cagrilintide-semaglutide [2·4 mg each]) or cagrilintide 1·0 mg plus semaglutide 1·0 mg (hereafter cagrilintide-semaglutide [1·0 mg each]) or dose-matched placebo (2·4 mg plus 2·4 mg or 1·0 mg plus 1·0 mg) for 40 weeks.
Sourcepmid-42251856· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2·4 mg; 1·0 mg
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise were randomly assigned (2:1:2:1) to receive once-weekly subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (cagrilintide-semaglutide [2·4 mg each]), placebo 2·4 mg plus 2·4 mg, cagrilintide 1·0 mg plus semaglutide 1·0 mg (cagrilintide-semaglutide [1·0 mg each]), or placebo 1·0 mg plus 1·0 mg for 40 weeks.
Sourcepmid-42251860· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2·4 mg; 1·0 mg
Participants aged 18 years or older with inadequately controlled type 2 diabetes (HbA 1c 7·0-10·5% [53-91 mmol/mol]) receiving metformin with or without an SGLT2 inhibitor, and a BMI of 25 kg/m 2 or more, were randomly assigned (8:8:2:8:8:1:1) to receive once-weekly subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (hereafter cagrilintide-semaglutide [2·4 mg each]), semaglutide 2·4 mg, cagrilintide 2·4 mg, cagrilintide 1·0 mg plus semaglutide 1·0 mg (hereafter cagrilintide-semaglutide [1·0 mg each]), semaglutide 1·0 mg, or corresponding placebo for 68 weeks.
Sourcepmid-42251859· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 2·4 mg
We assessed the efficacy and safety of a fixed-dose combination of cagrilintide 2·4 mg and semaglutide 2·4 mg versus semaglutide 2·4 mg for weight management in an east Asian population.
Sourcepmid-42009015· quoted verbatim from the abstract, emphasis added
Cagrilintide dosage chart: what the trials used
Cagrilintide is unusual here: the trial doses and the circulating doses are the same numbers. The difference is the product.
| Source of the figure | Dose | Schedule | What it showed |
|---|---|---|---|
| Phase 2 monotherapy (Lau 2021, 706 participants) | 0.3, 0.6, 1.2, 2.4 and 4.5 mg weekly | 26 weeks | Weight loss 6 to 10.8% vs 3% placebo; liraglutide 3 mg comparator 9% |
| CagriSema phase 3, REDEFINE 1 (Garvey 2025, 3,417) | 2.4 mg cagrilintide + 2.4 mg semaglutide weekly | 68 weeks, titrated over 16 | Weight −20.4% (trial-product estimand −22.7%) vs −3.0% placebo |
| CagriSema phase 3, REDEFINE 2 (Davies 2025, 1,206, type 2 diabetes) | 2.4 mg + 2.4 mg weekly | 68 weeks | Weight −13.7% vs −3.4%; HbA1c reductions greater than placebo |
| Titration used in the trials | 0.25 → 0.5 → 1.0 → 1.7 → 2.4 mg | Step every 4 weeks | Chosen to limit nausea |
| Commonly reported (grey market) | Same schedule, to 2.4 mg; some to 4.5 mg alone | Weekly | Unregulated vials; not the manufacturer's product |
Reading this table as a protocol misses the point of it: the numbers describe what the manufacturer tested under monitoring in defined populations. The vial on the grey market has not been shown to contain any of it.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
What side effects did the trials report?
Events and their frequency as each study reported them, with the denominator where the abstract gives one.
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Adverse events were reported in 524 (86·9%) of 603 participants in the cagrilintide-semaglutide (2·4 mg each) group, 491 (81·2%) of 605 in the semaglutide 2·4 mg group, 125 (82·2%) of 152 in the cagrilintide 2·4 mg group, 485 (81·6%) of 594 in the cagrilintide-semaglutide (1·0 mg each) group, 477 (78·5%) of 608 in the semaglutide 1·0 mg group, and 105 (70·5%) of 149 in the placebo group.
Sourcepmid-42251859· quoted verbatim from the abstract -
No increase in number of adverse events with increasing renal or hepatic impairment was observed, and no new safety or tolerability findings with cagrilintide were identified with renal or hepatic impairment.
Sourcepmid-42228334· quoted verbatim from the abstract -
17 (10%) participants discontinued cagrilintide-semaglutide and ten (6%) discontinued semaglutide.
Sourcepmid-42009015· quoted verbatim from the abstract -
Treatment with CagriSema resulted in significantly greater weight loss versus semaglutide and cagrilintide and was well tolerated.
Sourcepmid-37364590· quoted verbatim from the abstract -
According to the trial product estimand, mean percentage weight reductions from baseline were greater with all doses of cagrilintide (0·3-4·5 mg, 6·0%-10·8% [6·4-11·5 kg]) versus placebo (3·0% [3·3 kg]; estimated treatment difference range 3·0%-7·8%; p Interpretation Treatment with cagrilintide in people with overweight and obesity led to significant reductions in bodyweight and was well tolerated.
Sourcepmid-34798060· quoted verbatim from the abstract -
Of 566 adverse events reported in 92 participants (69 [97%] of 71 participants assigned to 0·16-4·5 mg cagrilintide and 23 [96%] of 24 assigned to placebo), 207 (37%) were gastrointestinal disorders.
Sourcepmid-33894838· quoted verbatim from the abstract
Who cagrilintide is being developed for, and the cautions from the trials
The populations studied. Adults with obesity, or overweight with a weight-related condition, with and without type 2 diabetes. That is who any approval would cover.
Cautions from the trials and the class.
- Gastrointestinal effects. Nausea, vomiting, constipation and diarrhoea in about four of five participants on CagriSema, mostly mild, mostly during titration. The slow step-up exists for this reason.
- Injection-site reactions. More frequent with cagrilintide than with semaglutide in the trials.
- Gallbladder, pancreas. Class-level cautions for weight-loss injectables; trial data are being gathered.
- Type 1 diabetes, pregnancy, eating disorders. Excluded from trials; no data.
- Grey-market product. Everything above assumes the drug in the trials. A research-chemical vial adds unknown identity, purity and dose to every one of these risks.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Biomarkers measured in studies
Laboratory and clinical measures the studies report tracking, including which hormones did and did not change.
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The phase 3a, 68-week REDEFINE 1 trial randomised adults without diabetes with BMI ≥ 30 kg/m 2 , or ≥ 27 kg/m 2 with ≥ 1 obesity-related complication, to once-weekly CagriSema 2.4 mg/2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg, or placebo, plus lifestyle intervention.
Sourcepmid-42503495· quoted verbatim from the abstract -
Cagrilintide monotherapy produced significant reductions in body weight (MD: -6.08%; MD: -5.89 kg) and blood pressure, without meaningful HbA1c improvement.
Sourcepmid-42583410· quoted verbatim from the abstract -
We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
Sourcepmid-42251856· quoted verbatim from the abstract -
The amylin receptor agonist cagrilintide and the GLP-1 receptor agonist semaglutide have complementary effects on glycaemic control and bodyweight.
Sourcepmid-42251859· quoted verbatim from the abstract -
The primary endpoint was area under the cagrilintide plasma concentration curve from time zero extrapolated to infinity (AUC 0-∞ ) from baseline (day 1) to day 36 (renal impairment study) or day 39 (hepatic impairment study).
Sourcepmid-42228334· quoted verbatim from the abstract -
The combination of cagrilintide and semaglutide has been shown in global studies to induce reductions in bodyweight.
Sourcepmid-42009015· quoted verbatim from the abstract
Reported interactions
Sentences in which the compound is studied alongside another agent. Read the quotation: the word interaction can also be statistical.
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We aimed to compare the efficacy and safety of a once per week combination of cagrilintide with semaglutide (CagriSema) versus placebo as an add-on to basal insulin in individuals with type 2 diabetes.
Sourcepmid-42251856· quoted verbatim from the abstract -
Data are needed on the coadministration of cagrilintide and semaglutide (called CagriSema) for weight management in adults with type 2 diabetes, including those in a subgroup who are undergoing continuous glucose monitoring.
Sourcepmid-40544432· quoted verbatim from the abstract -
This trial assessed the efficacy and safety of co-administered semaglutide with cagrilintide (CagriSema) in participants with type 2 diabetes.
Sourcepmid-37364590· quoted verbatim from the abstract -
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without lifestyle interventions.
Sourcepmid-33894838· quoted verbatim from the abstract -
Here, we determine structures of cagrilintide bound to Gs-coupled, active, amylin receptors (AMY 1 R, AMY 2 R, AMY 3 R) and calcitonin receptor (CTR) and compare cagrilintide interactions and the dynamics of receptor complexes with previously reported structures of receptors bound to rat amylin, salmon calcitonin or recently developed amylin-based peptides.
Sourcepmid-40204768· quoted verbatim from the abstract
Reported timelines
Onset, peak and duration figures as each study reported them.
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Secondary pharmacokinetic endpoints assessed from day of last dose (week 19) to end of treatment (week 20) were area under the plasma concentration-time curve from 0 to 168 h (AUC 0-168 h ) and maximum concentration [C max ] of cagrilintide and semaglutide; exploratory pharmacokinetic endpoints were half-life, time to C max [t max ], plasma clearance, and volume of distribution of cagrilintide and semaglutide; and exploratory pharmacodynamic endpoints were changes in bodyweight, glycaemic parameters, and hormones.
Sourcepmid-33894838· quoted verbatim from the abstract
What the trials measured over time
Measured. Weight loss continued through 68 weeks in the phase 3 trials, steepest in the first six months and still declining at the end. Nausea peaked during the titration steps and eased. Pharmacokinetic work shows exposure proportional to dose, a half-life of about a week, and no effect on semaglutide's exposure when given together.
Not yet measured. What happens after stopping, which for semaglutide alone is substantial regain; outcomes beyond 68 weeks; cardiovascular events, in a trial still running.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Escalation schedules used in studies
How trials stepped doses, reported as study design.
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Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
Sourcepmid-42009015· quoted verbatim from the abstract -
This was a double-blind study (NCT05804162) in which healthy participants were randomized to cagrilintide, administered as a once-weekly subcutaneous injection dose escalated to 4.5 mg, or a placebo.
Sourcepmid-39279639· quoted verbatim from the abstract -
Adults with type 2 diabetes and a BMI of 27 kg/m 2 or higher on metformin with or without an SGLT2 inhibitor were randomly assigned (1:1:1) to once-weekly subcutaneous CagriSema, semaglutide, or cagrilintide (all escalated to 2·4 mg).
Sourcepmid-37364590· quoted verbatim from the abstract -
In each cohort, the doses of cagrilintide and semaglutide were co-escalated in 4-week intervals to the desired dose over 16 weeks, participants were treated at the target dose for 4 weeks, and then followed up for 5 weeks.
Sourcepmid-33894838· quoted verbatim from the abstract
Study durations
Treatment and follow-up periods as stated in each abstract.
- Durations stated: 52 weeks
Eligible participants were randomly assigned to receive subcutaneous zalfermin 7·5 mg plus subcutaneous semaglutide 2·4 mg, zalfermin 15 mg plus semaglutide 2·4 mg, zalfermin 30 mg plus semaglutide 2·4 mg, zalfermin 30 mg, semaglutide 2·4 mg, cagrilintide 2·4 mg plus semaglutide 2·4 mg, or placebo only once a week for 52 weeks.
Sourcepmid-42456707· quoted verbatim from the abstract, emphasis added - Durations stated: 40 weeks
Adults with type 2 diabetes (glycated haemoglobin [HbA 1c ] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin were randomly assigned (2:2:1:1) to once per week subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (hereafter cagrilintide-semaglutide [2·4 mg each]) or cagrilintide 1·0 mg plus semaglutide 1·0 mg (hereafter cagrilintide-semaglutide [1·0 mg each]) or dose-matched placebo (2·4 mg plus 2·4 mg or 1·0 mg plus 1·0 mg) for 40 weeks.
Sourcepmid-42251856· quoted verbatim from the abstract, emphasis added - Durations stated: 18 years; 40 weeks
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise were randomly assigned (2:1:2:1) to receive once-weekly subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (cagrilintide-semaglutide [2·4 mg each]), placebo 2·4 mg plus 2·4 mg, cagrilintide 1·0 mg plus semaglutide 1·0 mg (cagrilintide-semaglutide [1·0 mg each]), or placebo 1·0 mg plus 1·0 mg for 40 weeks.
Sourcepmid-42251860· quoted verbatim from the abstract, emphasis added - Durations stated: 18 years; 68 weeks
Participants aged 18 years or older with inadequately controlled type 2 diabetes (HbA 1c 7·0-10·5% [53-91 mmol/mol]) receiving metformin with or without an SGLT2 inhibitor, and a BMI of 25 kg/m 2 or more, were randomly assigned (8:8:2:8:8:1:1) to receive once-weekly subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (hereafter cagrilintide-semaglutide [2·4 mg each]), semaglutide 2·4 mg, cagrilintide 2·4 mg, cagrilintide 1·0 mg plus semaglutide 1·0 mg (hereafter cagrilintide-semaglutide [1·0 mg each]), semaglutide 1·0 mg, or corresponding placebo for 68 weeks.
Sourcepmid-42251859· quoted verbatim from the abstract, emphasis added - Durations stated: 68 weeks
In this phase 3a, double-blind, randomized, placebo-controlled trial conducted in 12 countries, we assigned adults with a body-mass index of 27 or more, a glycated hemoglobin level of 7 to 10%, and type 2 diabetes in a 3:1 ratio to receive once-weekly cagrilintide-semaglutide (2.4 mg each) or placebo, along with lifestyle intervention, for 68 weeks.
Sourcepmid-40544432· quoted verbatim from the abstract, emphasis added - Durations stated: 26 week; 6 weeks; 6 week
The trial had a 26-week treatment period, including a dose-escalation period of up to 6 weeks, and a 6-week follow-up period without treatment.
Sourcepmid-34798060· quoted verbatim from the abstract, emphasis added
Routes studied
Routes of administration named in each study.
- administration by subcutaneous route reported
Eligible participants were randomly assigned to receive subcutaneous zalfermin 7·5 mg plus subcutaneous semaglutide 2·4 mg, zalfermin 15 mg plus semaglutide 2·4 mg, zalfermin 30 mg plus semaglutide 2·4 mg, zalfermin 30 mg, semaglutide 2·4 mg, cagrilintide 2·4 mg plus semaglutide 2·4 mg, or placebo only once a week for 52 weeks.
Sourcepmid-42456707· quoted verbatim from the abstract - administration by subcutaneous route reported
Adults with type 2 diabetes (glycated haemoglobin [HbA 1c ] 7·0-10·5%) receiving stable once per day basal insulin with or without metformin were randomly assigned (2:2:1:1) to once per week subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (hereafter cagrilintide-semaglutide [2·4 mg each]) or cagrilintide 1·0 mg plus semaglutide 1·0 mg (hereafter cagrilintide-semaglutide [1·0 mg each]) or dose-matched placebo (2·4 mg plus 2·4 mg or 1·0 mg plus 1·0 mg) for 40 weeks.
Sourcepmid-42251856· quoted verbatim from the abstract - administration by subcutaneous route reported
Adults aged 18 years or older with type 2 diabetes inadequately controlled with diet and exercise were randomly assigned (2:1:2:1) to receive once-weekly subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (cagrilintide-semaglutide [2·4 mg each]), placebo 2·4 mg plus 2·4 mg, cagrilintide 1·0 mg plus semaglutide 1·0 mg (cagrilintide-semaglutide [1·0 mg each]), or placebo 1·0 mg plus 1·0 mg for 40 weeks.
Sourcepmid-42251860· quoted verbatim from the abstract - administration by subcutaneous route reported
Participants aged 18 years or older with inadequately controlled type 2 diabetes (HbA 1c 7·0-10·5% [53-91 mmol/mol]) receiving metformin with or without an SGLT2 inhibitor, and a BMI of 25 kg/m 2 or more, were randomly assigned (8:8:2:8:8:1:1) to receive once-weekly subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (hereafter cagrilintide-semaglutide [2·4 mg each]), semaglutide 2·4 mg, cagrilintide 2·4 mg, cagrilintide 1·0 mg plus semaglutide 1·0 mg (hereafter cagrilintide-semaglutide [1·0 mg each]), semaglutide 1·0 mg, or corresponding placebo for 68 weeks.
Sourcepmid-42251859· quoted verbatim from the abstract - administration by subcutaneous route reported
Participants were randomly assigned (1:1) to once-weekly subcutaneous injections of cagrilintide-semaglutide or semaglutide (both escalated to 2·4 mg), plus lifestyle intervention, for 68 weeks.
Sourcepmid-42009015· quoted verbatim from the abstract - administration by subcutaneous route reported
This was a double-blind study (NCT05804162) in which healthy participants were randomized to cagrilintide, administered as a once-weekly subcutaneous injection dose escalated to 4.5 mg, or a placebo.
Sourcepmid-39279639· quoted verbatim from the abstract
What people report outside the trials
What circulates in user communities and clinic marketing, reported so a reader knows the figures and their origin. None of it has been tested in a trial, and none of it is a suggestion.
- Editorial synthesis from general knowledge
- Editorial synthesis from general knowledge
Reconstituting cagrilintide: concentrations for common vial sizes
Research-chemical cagrilintide is sold as powder in 5 and 10 mg vials. The arithmetic is exact; the choice of what to draw is not made here.
| Vial | Diluent added | Concentration | Worked examples on a U-100 syringe |
|---|---|---|---|
| 5 mg | 2 mL | 2,500 µg/mL | 0.10 mL (10 units) holds 250 µg; 0.96 mL holds 2.4 mg |
| 5 mg | 2.5 mL | 2,000 µg/mL | 0.125 mL holds 250 µg; 1.2 mL holds 2.4 mg |
| 10 mg | 2 mL | 5,000 µg/mL | 0.05 mL holds 250 µg; 0.48 mL holds 2.4 mg |
| 10 mg | 4 mL | 2,500 µg/mL | 0.10 mL holds 250 µg; 0.96 mL holds 2.4 mg |
The titration schedule means the same vial is drawn at very different volumes over four months, and the early doses are small volumes that are easy to misread. The reconstitution calculator shows its formula.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Reconstitution mathematics
Lyophilised peptide is supplied as a mass in a vial and dissolved in a stated volume of diluent. Two figures follow from that and nothing else:
- Concentration = mass in vial ÷ diluent volume. A 5 mg vial in 2 mL is 2.5 mg/mL, or 2,500 mcg/mL.
- Volume for a given mass = that mass ÷ concentration. 250 mcg at 2,500 mcg/mL is 0.1 mL. On a U-100 insulin syringe, where 1 mL is 100 units, that is 10 units.
Study doses on this page are quoted as published, in the units the authors used. Converting between mcg, mg and IU, or between a mass and a syringe volume, is arithmetic; deciding a mass is not, and this page does not do it. The reconstitution calculator performs the conversion with the formula shown.
Reading a certificate of analysis
A certificate of analysis is a laboratory report on one batch. Reading it means checking four things in order.
- Identity. Mass spectrometry should report an observed molecular mass matching the peptide's theoretical mass within the instrument's stated tolerance. A certificate with no mass spectrometry, or one that lists only the expected value, has not confirmed identity.
- Purity. HPLC purity is the area of the main peak as a share of all peaks, at a stated wavelength. It says nothing about what the other peaks are, and it is not a measure of quantity.
- Quantity. Net peptide content, by amino acid analysis or UV, is the fraction of the vial's mass that is peptide rather than counter-ions and water. A 5 mg vial at 80% net content holds 4 mg of peptide, and every concentration figure above changes accordingly.
- Provenance. The batch number on the certificate should match the vial, the laboratory should be named and independent of the seller, and the test date should be recent.
This page rates no supplier and links to none. It describes how to read the document.
Equipment described in studies
Published human studies of injectable peptides report the same small set of materials: single-use insulin syringes with fixed needles, most often U-100 with 29 to 31 gauge needles; bacteriostatic water or sterile water for injection as diluent, with the choice stated in the methods; alcohol swabs; and refrigerated storage of reconstituted solution. Animal studies more often report intraperitoneal or intragastric administration and state the vehicle used. Where a study in this record's ledger names its materials or vehicle, that sentence appears under storage or routes above; where it does not, nothing is assumed here.
Storage and handling
The manufacturer's product will carry its own instructions. Research-chemical powder is refrigerated or frozen, protected from light; reconstituted solution is refrigerated and typically used within about four weeks, which the titration schedule may exceed for a single vial. Discard cloudy or discoloured solution.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
What the trials monitored
Unlike most compounds here, there is a real list, because the trials kept one.
| Measure | Why | When |
|---|---|---|
| Body weight and waist | Primary endpoints | Every visit |
| HbA1c and fasting glucose | Primary in the diabetes trial; safety elsewhere | Baseline, then periodically |
| Blood pressure and lipids | Secondary endpoints; both improved with weight loss | Periodically |
| Heart rate and ECG | A dedicated study found no clinically relevant QT prolongation | Baseline; dedicated study |
| Kidney and liver function | A dedicated study in renal and hepatic impairment found no new safety signals | Baseline; dedicated study |
| Amylase, lipase, gallbladder symptoms | Class cautions | As indicated |
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Common mistakes in how cagrilintide is discussed
- Treating trial results as results for grey-market vials. The pharmacology is the same only if the vial contains the drug.
- Quoting CagriSema results for cagrilintide alone. Alone it produced about half the weight loss.
- Skipping titration. The step-up exists because nausea at full dose without it was the finding.
- Calling it approved. As of this writing it is not, anywhere.
- Calling it a GLP-1. It is an amylin analogue; that is the whole reason it adds to semaglutide.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Cagrilintide vs semaglutide, tirzepatide, retatrutide and survodutide
The weight-loss injectables people compare it with. Only two are approved.
| Compound | Mechanism | Weight loss in trials (approx.) | Status |
|---|---|---|---|
| Cagrilintide | Amylin analogue | Phase 3; ~11% alone, ~20% with semaglutide | Not approved |
| Semaglutide | GLP-1 agonist | Approved; ~15% (STEP 1) | Approved 2017 (diabetes), 2021 (obesity) |
| Tirzepatide | GLP-1 + GIP agonist | Approved; ~21% (SURMOUNT-1) | Approved 2022 |
| Retatrutide | GLP-1 + GIP + glucagon agonist | Phase 3; ~24% at 48 weeks in phase 2 | Not approved |
| Survodutide | GLP-1 + glucagon agonist | Phase 3; ~15% in phase 2 | Not approved |
Percentages come from different trials with different populations and durations and are not head-to-head; the one direct comparison so far is CagriSema against semaglutide alone within the REDEFINE programme, and a trial against tirzepatide is running. Pages: cagrilintide vs semaglutide, the CagriSema combination, and the records for semaglutide, tirzepatide, retatrutide and survodutide.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Exclusion criteria in studies
Who each trial excluded, as stated in the abstract.
-
Eligible participants were randomly assigned to receive subcutaneous zalfermin 7·5 mg plus subcutaneous semaglutide 2·4 mg, zalfermin 15 mg plus semaglutide 2·4 mg, zalfermin 30 mg plus semaglutide 2·4 mg, zalfermin 30 mg, semaglutide 2·4 mg, cagrilintide 2·4 mg plus semaglutide 2·4 mg, or placebo only once a week for 52 weeks.
Sourcepmid-42456707· quoted verbatim from the abstract -
Eligible randomized controlled trials (RCTs) assessed Cagrilintide monotherapy or CagriSema versus placebo.
Sourcepmid-42583410· quoted verbatim from the abstract -
Between March 19 and Dec 5, 2024, 294 people were screened for eligibility, 189 of whom were enrolled and randomly assigned to cagrilintide-semaglutide (2·4 mg each; n=62), cagrilintide-semaglutide (1·0 mg each; n=63), or placebo (n=64).
Sourcepmid-42251860· quoted verbatim from the abstract -
From Oct 10, 2023, to July 29, 2024, 3593 people were screened for eligibility, 2713 of whom were randomly assigned to cagrilintide-semaglutide (2·4 mg each; n=603), semaglutide 2·4 mg (n=605), cagrilintide 2·4 mg (n=152), cagrilintide-semaglutide (1·0 mg each; n=595), semaglutide 1·0 mg (n=609), or placebo (pooled 2·4 mg and 1·0 mg; n=149).
Sourcepmid-42251859· quoted verbatim from the abstract -
The trial included six sequential overlapping cohorts, and in each cohort eligible participants were randomly assigned (3:1) to once-weekly subcutaneous cagrilintide (0·16, 0·30, 0·60, 1·2, 2·4, or 4·5 mg) or matched placebo, in combination with once-weekly subcutaneous semaglutide 2·4 mg, without lifestyle interventions.
Sourcepmid-33894838· quoted verbatim from the abstract
Other compounds in its class
Same class in the registry: Retatrutide, Semaglutide, Survodutide, Tirzepatide. Each row shows what that compound's own record states; nothing is inferred across rows. Head-to-head evidence, where any exists, is on the comparison page: Cagrilintide vs Semaglutide.
| Compound | Tier | Publications | RCTs | Record |
|---|---|---|---|---|
| Cagrilintide | Human clinical trial | 105 | 15 | draft |
| Retatrutide | Human clinical trial | 197 | 7 | draft |
| Semaglutide | Approved label | 6,039 | 305 | draft |
| Survodutide | Human clinical trial | 91 | 10 | draft |
| Tirzepatide | Approved label | 2,756 | 131 | draft |
CagriSema: cagrilintide with semaglutide
Whether any indexed study tested Cagrilintide together with the compounds it is commonly combined with. A count of zero is the finding, not a gap in this page.
- 15 indexed studies mention Cagrilintide together with Semaglutide. Cagrilintide + semaglutide (CagriSema)
Is cagrilintide approved?
Registry facts only. Jurisdiction-level status, compounding categories and sport prohibitions need their own cited documents before they appear here.
- Registry entry
- Editorial synthesis from general knowledge · primary document to be added to the ledger
Open questions and limitations
What is genuinely unknown, stated plainly. A missing field is not evidence that the outcome is safe, effective, or established.
- No study in this record's ledger reports weight-normalized doses for Cagrilintide.
- No study in this record's ledger reports storage or stability for Cagrilintide.
Questions people ask
What is cagrilintide?
A once-weekly analogue of amylin, the fullness hormone released with insulin, developed by Novo Nordisk as a weight-loss drug on its own and, combined with semaglutide as CagriSema, as the company's next obesity medicine.
What is CagriSema?
Cagrilintide 2.4 mg plus semaglutide 2.4 mg in one weekly injection. In phase 3 it reduced weight by about 20 percent over 68 weeks in adults without diabetes and about 14 percent in adults with type 2 diabetes.
Is cagrilintide FDA approved?
No, not anywhere, as of September 2026. Phase 3 trials of CagriSema are complete and a submission is in progress; cagrilintide alone is in phase 3.
What is the cagrilintide dose?
The trials titrated weekly injections from 0.25 mg through 0.5, 1.0 and 1.7 to 2.4 mg, stepping every four weeks; monotherapy was tested to 4.5 mg. These are trial doses of the manufacturer's product, not a recommendation for anything sold as a research chemical.
What is cagrilintide's half-life?
About a week, which is what allows once-weekly dosing; exposure rises in proportion to dose.
What are the side effects of cagrilintide?
Gastrointestinal, in about four of five people on CagriSema: nausea, vomiting, constipation, diarrhoea, mostly mild and during titration. Injection-site reactions were more common than with semaglutide. Long-term effects are still being studied.
How much weight loss does cagrilintide produce?
About 11 percent over 26 weeks alone at 4.5 mg; about 20 percent over 68 weeks combined with semaglutide in adults without diabetes; about 14 percent in adults with type 2 diabetes.
Cagrilintide vs semaglutide: what is the difference?
Different hormones. Semaglutide mimics GLP-1; cagrilintide mimics amylin. Combined they produce more weight loss than semaglutide alone, which is the point of CagriSema.
Cagrilintide vs retatrutide?
Retatrutide is a triple agonist (GLP-1, GIP, glucagon) with about 24 percent weight loss at 48 weeks in phase 2; cagrilintide alone produced about 11 percent. Neither is approved, and they have not been compared directly.
Can cagrilintide be taken with semaglutide?
That combination is CagriSema, the product in phase 3. Grey-market imitation of it uses unregulated vials of both.
How is cagrilintide reconstituted?
Research-chemical powder dissolved in bacteriostatic water; 5 mg in 2 mL gives 2,500 micrograms per mL, so 2.4 mg is just under 1 mL. The trial product is a pre-filled pen.
Why is cagrilintide titrated?
To limit nausea. Starting at the full dose produced more gastrointestinal effects in early work, so the trials stepped up every four weeks.
Is cagrilintide a GLP-1?
No. It is an amylin analogue acting on amylin and calcitonin receptors, a different pathway, which is why it adds to semaglutide rather than duplicating it.
Does cagrilintide affect blood sugar?
With semaglutide in people with type 2 diabetes, HbA1c fell more than with placebo or semaglutide alone. Alone, it improved glucose measures modestly in the phase 2 trial.
Is cagrilintide banned in sport?
It is not named on the WADA Prohibited List.
When will cagrilintide be approved?
Novo Nordisk has indicated a regulatory submission for CagriSema; decisions typically follow within a year. No date is certain, and this page will say when a regulator has decided.
Sources
Full citations. Every claim above links to one of these by its id.
- 1
- 2
- 3
- 4Amylin-based obesity therapy: a meta-analysis of Cagrilintide and CagriSema versus placebo.
pmid-42583410· · peer-reviewed - 5A cross-species atlas of the dorsal vagal complex reveals neural mediators of the effects of cagrilintide on energy balance.
pmid-42260119· · peer-reviewed - 6
- 7
- 8
- 9Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.
pmid-42228334· · peer-reviewed - 10
- 11Mitochondrial Adaptations in Skeletal Muscle Following Incretin-Based Therapies: In Vitro.
pmid-41852165· · peer-reviewed - 12In vitro metabolic profiling of weight-loss-inducing amylin receptor agonists in the context of preventive doping research.
pmid-41702251· · peer-reviewed
Show the remaining 19 sources
- 13CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1.
pmid-41328546· · peer-reviewed - 14Synthetic target trial emulation and predictive modeling of amylin-pathway therapies for obesity and type 2 diabetes.
pmid-41255585· · peer-reviewed - 15
- 16
- 17Structural and mechanistic insights into dual activation of cagrilintide in amylin and calcitonin receptors.
pmid-40847076· · peer-reviewed - 18CagriSema drives weight loss in rats by reducing energy intake and preserving energy expenditure.
pmid-40629149· · peer-reviewed - 19Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3.
pmid-40609154· · peer-reviewed - 20Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity.
pmid-40544433· · peer-reviewed - 21Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.
pmid-40544432· · peer-reviewed - 22Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors.
pmid-40204768· · peer-reviewed - 23Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants.
pmid-39279639· · peer-reviewed - 24
- 25
- 26An update on peptide-based therapies for type 2 diabetes and obesity.
pmid-36608818· · peer-reviewed - 27Creating the amylin story.
pmid-35183619· · peer-reviewed - 28Amylin as a Future Obesity Treatment.
pmid-34929674· · peer-reviewed - 29
- 30Emerging glucagon-like peptide 1 receptor agonists for the treatment of obesity.
pmid-34176426· · peer-reviewed - 31
Reference card
- Compound
- Cagrilintide, incretin and amylin analogs
- Evidence tier
- Human clinical trial
- Indexed publications
- 105 · 15 RCTs · 13 other clinical trials
- Approval
- not approved · max phase 3
- Routes reported
- subcutaneous
- Reviewed
- Adam Mirando, PharmD,
Study figures are as published in each source and are not recommendations. Print or save this card with its date.
Last reviewed and what changed
Newest first. These are the record's own revision dates, and the same dates feed the sitemap.
- · Reviewed by Adam Mirando, PharmD, on 2026-09-25.
- · Label correction: 1 evidence rows built from detection and doping-control papers carried study designs such as animal or in-vitro work. They are relabelled Analytical method, the label scripts/draft_claims.py has applied since the rule was added; these rows predate it. pmid-41702251 (Animal study -> Analytical method)
- · Misattribution check: evidence_table (pmid-42688617): the quoted result is about danuglipron, retatrutide and mazdutide tolerability and says nothing about cagrilintide. The sources stay in the ledger; only the claims that put another agent's result under this compound were removed.
- · Written guide (9 sections), FAQ to 16, mechanism, reported-use and regulatory editorial sections (phase 3, not approved; document pending), intent-driven H1 and title. Fifth compound through the loop.
- · Claims drafted extractively from 31 ledger sources by scripts/draft_claims.py: 45 claims, 25 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 31 ledger sources by scripts/draft_claims.py: 53 claims, 25 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 31 ledger sources by scripts/draft_claims.py: 53 claims, 25 evidence-table rows. Status researched -> draft.
- · Evidence fetched from Europe PMC and ChEMBL by scripts/fetch_evidence.py; claims not yet written.