CagriSema dosage and dosing schedule: the trial titration step by step

The phase 2 paper prints this ladder in full: treatment doses were escalated every 4 weeks from 0.25 mg to 0.5 mg, 1.0 mg and 1.7 mg until the 2.4 mg maintenance dose was reached after 16 weeks ^[1]. The earlier phase 1b trial used the same pattern, co-escalating cagrilintide and semaglutide in 4-week intervals over 16 weeks ^[4]. The phase 3 papers describe both drugs as escalated to 2.4 mg ^[5].

The semaglutide half of the ladder is the same one on the approved Wegovy label, which starts at 0.25 mg weekly for 4 weeks and titrates every 4 weeks through 0.5, 1 and 1.7 mg to 2.4 mg ^[6]. What CagriSema adds is a cagrilintide dose that moves in lockstep with it. For the cagrilintide component in more detail, see the cagrilintide dosage guide.

After titration, the weight-management trials held participants at 2.4 mg of each drug weekly for the rest of the treatment period. In the phase 2 trial that meant 16 weeks of escalation, then 16 weeks of maintenance, then 5 weeks of follow-up ^[1]. In phase 3 the treatment periods were longer:

• REDEFINE 1, adults without diabetes, 68 weeks: weight changed by -20.4% on CagriSema against -3.0% on placebo ^[2].
• REDEFINE 2, adults with type 2 diabetes, 68 weeks: -13.7% against -3.4% ^[7].
• REDEFINE 5, adults in Japan and Taiwan, 68 weeks: -18.4% against -11.9% on semaglutide 2.4 mg alone ^[5].

The cagrilintide vs semaglutide comparison sets those numbers against each component on its own.

The schedule above is the plan. REDEFINE 1 allowed it to bend: Novo Nordisk described the trial as based on a flexible protocol, allowing patients to modify their dosing throughout ^[8]. In practice that meant a participant's dose could differ from the chart.

Many did. At week 68, 57.3% of people on CagriSema were on the highest dose, against 82.5% of those on cagrilintide 2.4 mg alone and 70.2% of those on semaglutide 2.4 mg alone ^[8]. The headline 22.7% weight loss (trial-product estimand) and the 20.4% in the published paper (treatment-policy estimand) were therefore achieved with more than four in ten people below the full 2.4/2.4 mg dose ^[8][2].

The approved semaglutide label has a comparable provision for its own ladder: if a dose is not tolerated during escalation, prescribers may consider delaying the next step by 4 weeks ^[6]. Gastrointestinal effects drive most of these adjustments; the cagrilintide side effects page reports how often they occurred.

Novo Nordisk is still testing what the full schedule can deliver. REDEFINE 11, an 80-week trial of CagriSema 2.4/2.4 mg in 600 adults, is expected to report in the first half of 2027, and a trial of a higher-dose version, cagrilintide 2.4 mg with semaglutide 7.2 mg, was planned to begin in the second half of 2026 ^[9].

The REIMAGINE programme in type 2 diabetes also tested a smaller pair, cagrilintide 1.0 mg with semaglutide 1.0 mg. REIMAGINE 2 randomised 2,713 adults on metformin to six arms, including 595 on the 1.0/1.0 mg combination ^[10]. In REIMAGINE 3, in 274 adults on basal insulin, HbA1c fell by 2.10 points on 1.0/1.0 mg and 2.33 points on 2.4/2.4 mg, against 0.66 on placebo, over 40 weeks ^[11].

Both doses met their primary endpoints in that trial ^[11]. Whether a lower maintenance dose ends up on a diabetes label is a regulatory question that has not been answered: the December 2025 submission was for weight management ^[3].

Early trials gave the two drugs as separate injections. In the phase 2 diabetes trial, semaglutide came from one pre-filled pen and cagrilintide from another ^[1]. The product submitted for approval is a fixed-dose combination of both ^[3].

A 2026 usability study tested the device built for it: a single-dose, single-use, pre-filled dual-chamber pen for once-weekly subcutaneous injection of the fixed-dose combination. Of 150 adults with overweight, obesity or type 2 diabetes, all but one completed a simulated injection; median training took 3 minutes and preparing and injecting took 15 seconds ^[12].

A fixed ratio has a consequence for the schedule: the two doses cannot be adjusted independently. Each step on the chart is a step for both drugs at once. Where the injection goes is covered in subcutaneous injection sites.

Novo Nordisk submitted CagriSema to the FDA in December 2025, on the strength of REDEFINE 1 and REDEFINE 2 ^[3]. In February 2026 the company said it anticipated an FDA decision by late 2026 ^[9]. Until a label is issued, there is no approved starting dose, no approved escalation rule and no approved maintenance dose; the schedule on this page is the trial protocol and nothing more. The CagriSema approval timeline tracks the review.

Schedules offered online for vials sold as "CagriSema" or as separate cagrilintide and semaglutide copy these trial steps onto products whose identity and strength nobody has verified, and assembling two vials does not reproduce a fixed-dose product. The cagrilintide record explains why, and the cagrilintide calculator shows the volume arithmetic for the trial doses without turning them into a recommendation.