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CaHuman trials

Cagrilintide protocol

A once-weekly long-acting amylin analogue. Studied alone and with semaglutide as CagriSema. Not approved anywhere yet.

Investigational · not approvedPhase 3 done as CagriSema
ProtocolMixingResultsSide effectsHow it worksSources

The protocol at a glance

Once a week. In the CagriSema phase 3 trials, cagrilintide stepped up every 4 weeks over 16 weeks to 2.4 mg, alongside semaglutide on the same schedule.

WeeksWeekly cagrilintide amount in REDEFINE 1
1–40.25 mg
5–80.5 mg
9–121 mg
13–161.7 mg
17+2.4 mg

Combining cagrilintide with tirzepatide or retatrutide has not been studied in a controlled trial.

Community reports

Community reports describe using the same 4-week steps as the trials, sometimes alongside tirzepatide or retatrutide instead of semaglutide. That combination has not been studied.

What people say they do, collected from community discussions. Not tested in a trial; shown so you can compare it with the evidence above.

Mixing calculator

Enter the vial size, the water you add and the amount you want to draw; it gives the mark on a 100-unit (1 mL) insulin syringe.

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What the trials found

REDEFINE 1 (3,417 adults with obesity or overweight, no diabetes, 68 weeks). Average body-weight change:

−20.4%CagriSema 2.4 / 2.4 mg
about −12%Cagrilintide 2.4 mg alone
about −16%Semaglutide 2.4 mg alone
−3.0%Placebo

Garvey WT et al., N Engl J Med 2025 (REDEFINE 1). Single-drug figures as reported by Novo Nordisk; check the paper for the exact analysis.

Side effects

  • Stomach side effects (nausea, vomiting, diarrhoea, constipation) were the most common, mostly mild to moderate and during step-ups.
  • Side effects add up when combined with a GLP-1 drug.

How it works

Amylin receptor

Amylin is released with insulin after meals. It slows stomach emptying and signals fullness through a different pathway from GLP-1.

Sources

  • Garvey WT et al. N Engl J Med 2025 (REDEFINE 1)
  • Novo Nordisk REDEFINE 1 releases, 2025