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Weight & metabolism
CagriSema: the amylin + semaglutide shot behind −20.4% in Phase 3
Investigational: not FDA-approved Checked against PubMed and official sources Oct 18, 2026
Quick facts
- What it is: a long-acting amylin (fullness hormone) shot, paired with semaglutide as CagriSema.
- Status: investigational. Novo submitted CagriSema to the FDA in Dec 2025; no decision announced.
- Headline result: −20.4% average weight at 68 weeks in REDEFINE 1, vs −3.0% on placebo.
- Side effects: mostly gastrointestinal.
- Compounding: the FDA says cagrilintide can't be compounded.
What are cagrilintide and CagriSema?
Cagrilintide is a long-acting version of amylin, a hormone released with insulin that helps you feel full. CagriSema is Novo Nordisk's once-weekly combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, and if approved it would be the first injectable GLP-1 plus amylin combination (Novo Nordisk).
Is CagriSema FDA-approved?
Investigational, not FDA-approved. Novo Nordisk submitted CagriSema to the FDA on Dec 18, 2025 (Novo Nordisk); no decision has been announced.
Investigational, not FDA-approved. Known risks: gastrointestinal side effects in 79.6% vs 39.9% on placebo in REDEFINE 1 (NEJM, 2025); online "research" versions aren't the trial drug. Choose a tested source.
Dosage
No approved dose yet. The trials tested cagrilintide 2.4 mg plus semaglutide 2.4 mg once weekly, the strength Novo submitted to the FDA. This is Novo's fixed-dose trial product, not a guide for "research" cagrilintide.
What the research shows
- REDEFINE 1 (NEJM, 2025): 3,417 adults with obesity or overweight and no diabetes, 68 weeks. CagriSema: −20.4% average weight change vs −3.0% on placebo (treatment-policy estimand, which counts dropouts). Gastrointestinal side effects hit 79.6% vs 39.9% on placebo, mostly mild to moderate and temporary.
- REDEFINE 2 (NEJM, 2025): 1,206 adults with type 2 diabetes, 68 weeks. −13.7% vs −3.4% on placebo (counts dropouts), and 73.5% reached an HbA1c of 6.5% or less vs 15.9%.
- Different trials from tirzepatide's and retatrutide's, so compare loosely. See the GLP-1 comparison.
New to these terms? See the glossary.
Cagrilintide & CagriSema FAQ
How much weight do people lose on CagriSema?
In REDEFINE 1, the average was −20.4% at 68 weeks vs −3.0% on placebo, counting dropouts. In people with type 2 diabetes (REDEFINE 2), −13.7% vs −3.4%.
Is CagriSema FDA-approved?
Not yet. Novo Nordisk submitted it to the FDA on Dec 18, 2025, and no decision has been announced as of Oct 18, 2026.
Can cagrilintide be compounded?
No. The FDA says cagrilintide can't be compounded under federal law.
What dose was used in trials?
The trial arm was cagrilintide 2.4 mg plus semaglutide 2.4 mg once weekly. There's no approved dose yet.
Not medical advice. Education only. Talk to a licensed clinician about your health.
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