Cagrilintide

Long-acting amylin analogue peptide

Also known as: Cagri· community shorthand

Obesityappetite and weight-man…

Cagrilintide

Evidence levelLate-stage human

Human evidenceSubstantial

Regulatory statusNot FDA-approved

What you need to know in 20 seconds

What is it?	Long-acting amylin analogue peptide
Research focus	Obesity, appetite and weight-management research
Human evidence	Cagrilintide has randomized Phase II weight-loss evidence and a Phase IIIa monotherapy arm within REDEFINE 1; cagrilintide 2.4 mg weekly produced roughly 11.5%-11.8% mean weight reduction at 68 weeks depending on estimand.
Regulatory status	FDA states cagrilintide is not a component of an FDA-approved drug, has not been found safe and effective for any condition, and cannot be used in U.S. compounding under federal law.
Main limitations	Marketing approval, long-term outcomes, and whether monotherapy matches the benefit-risk of studied CagriSema combination regimens.
Safety	GI adverse effects are prominent; long-term safety remains investigational.

Cagrilintide has randomized Phase II weight-loss evidence and a Phase IIIa monotherapy arm within REDEFINE 1; cagrilintide 2.4 mg weekly produced roughly 11.5%-11.8% mean weight reduction at 68 weeks depending on estimand.

What the evidence actually supports

✓Strong investigational human evidence, clearly below approved-product certainty.
✓Enough to move the component page to deep research while preserving investigational status.
✓Keep regulatory status independent from trial-stage strength.

What is not established / key limitations

×Not yet equivalent to an established approved obesity-treatment evidence package; GI adverse effects were common.
×It remained less effective than the CagriSema combination in the same trial; cross-arm interpretation must use the stated estimand.
×No FDA-approved cagrilintide monotherapy or CagriSema product is established by this record.

Selected study & evidence records

Once-weekly cagrilintide Phase II weight-management trial

2021 · Randomized double-blind placebo- and active-controlled dose-ranging trial · n=706

Mean weight reductions ranged 6.0%-10.8% across cagrilintide doses versus 3.0% placebo; 4.5 mg produced 10.8% versus 9.0% with liraglutide.

Study detail → Primary source ↗

REDEFINE 1 cagrilintide 2.4 mg monotherapy arm

2025 · Randomized, double-blind, placebo- and active-controlled Phase IIIa trial; monotherapy arm within larger trial · n=302 cagrilintide arm

Detailed REDEFINE 1 reporting shows about 11.5% treatment-policy / 11.8% trial-product-estimand weight reduction with cagrilintide 2.4 mg monotherapy versus about 3.0% / 2.3% placebo.

Study detail → Primary source ↗

Safety and unknowns

GI adverse effects are prominent; long-term safety remains investigational.

GI adverse events were common (41%-63% across cagrilintide doses versus 32% placebo); nausea occurred in 20%-47% versus 18%.

Technical details

Mechanism / biologyAmylin-receptor agonism influences satiety, gastric emptying and energy intake.

Route / formulation boundaryTrial evidence does not establish quality or equivalence of research-market material.

Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.

Dosing evidence statusVerified dosing evidence added. Published Phase 2 human trial regimen. See dosing_evidence records for route, regimen, population, duration and source.

Identifiers & alternate namesCagri