#4Metabolic & Frontier
Cagrilintide
long-acting amylin analogue
Evidence: human RCTReviewed 2026-07-25
Investigated uses
- Obesity and weight management, alone and with semaglutide.
Mechanism and hypotheses
- Cagrilintide is a long-acting amylin analogue that engages amylin/calcitonin-family receptors and reduces energy intake in clinical development.
- Hypothesized: The precise contribution of individual receptor subtypes to long-term weight reduction remains under investigation.
Human evidence
- A phase 2 trial randomized 706 adults to weekly cagrilintide dose arms, daily liraglutide or placebo for 26 weeks; weight loss was dose-dependent and exceeded placebo. Limitations: Short duration for chronic therapy; investigational product and sponsor setting.
Safety highlights
- Gastrointestinal adverse events, especially nausea, were common in phase 2.
- Long-term pancreatic, biliary, cardiovascular and rare-event risks remain incompletely characterized.
Regulatory context
Cagrilintide was not FDA-approved as of the review date; FDA states it cannot be used in compounding under the cited framework.
Sources used for this entry
- PubMed search: Cagrilintide — PubMed
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — U.S. Food and Drug Administration
- Drugs@FDA database — U.S. Food and Drug Administration
- EMA medicines search — European Medicines Agency
- NCT03856047: Cagrilintide phase 2 obesity trial — ClinicalTrials.gov
- Cagrilintide weight-management phase 2 trial — The Lancet / PubMed