Cagrilintide has late-stage human evidence for weight management. It has been tested on its own in Phase 3 research, and a dedicated Phase 3 programme is underway. It remains investigational and is not FDA-approved.
Still uncertain: Marketing approval, long-term outcomes and how cagrilintide alone compares with the separate CagriSema combination programme.
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What does the evidence mean in simple terms? table
What is it?
Long-acting amylin analogue peptide
Entity type
Peptide analogue / modified peptide
Research focus
Obesity, appetite and weight-management research
Human evidence
Cagrilintide has randomized Phase II evidence and a Phase IIIa monotherapy arm within REDEFINE 1; the dedicated RENEW Phase 3 monotherapy programme is underway.
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.
Evidence reviewed
2026-09-18
i
Cagrilintide has randomized Phase II evidence and a Phase IIIa monotherapy arm within REDEFINE 1; the dedicated RENEW Phase 3 monotherapy programme is underway.
Outcome-level evidence
Evidence is not one score.
Each record below answers a narrower question about an outcome, population or context. Evidence status and the study finding are shown separately so strong evidence is not mistaken for a positive effect.
Phase IIIa monotherapy arm within active-controlled RCT
Context: Adults with obesity/overweight without diabetes
Finding: Cagrilintide has late-stage monotherapy efficacy data, not only Phase II evidence.
Uncertainty / evidence gap: It remained less effective than the CagriSema combination in the same trial; cross-arm interpretation must use the stated estimand.
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.
Study / label regimen evidenceVerified study/label regimen evidence is available. Published Phase 2 human trial regimen. Open descriptive regimen evidence →
WhichPeps does not rely on a single headline study when the evidence base is broader. Primary research, registries, regulators and supporting records are kept distinct.
2structured study records
3outcome records
10linked source records
How to read these counts: they show evidence coverage, not evidence strength. One large, well-designed study can be more informative than several weak or indirect records.
Show supporting and discovery sources
Study pages above contain the records used for public evidence summaries. The links below include supporting, regulatory and literature-discovery sources; a registry or search result is not treated as proof of benefit.
PubMed / peer-reviewed source ↗ — Supports contraindication, interaction, monitoring, pregnancy or formulation-safety context in the safety evidence layer.
PubMed / peer-reviewed source ↗ — Combination-specific evidence for cagrilintide 2.4 mg + semaglutide 2.4 mg in adults with overweight/obesity.
PubMed / peer-reviewed source ↗ — Combination-specific evidence for cagrilintide 2.4 mg + semaglutide 2.4 mg in adults with overweight/obesity and type 2 diabetes.
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.
