PEP-0015Investigational

CAGRILINTIDE

Also known as

Long-acting amylin analogue in late-clinical trials for metabolic health and weight management. Strong evidence grade from Phase 2/3 data; most studied in combination with semaglutide (cagrisema). Moderate risk.


Evidence

Strong· 8.4

Strong human RCT or meta-analysis

Risk band

Moderate

Known AEs, monitoring advised

Summary

Cagrilintide is a long-acting amylin analog studied as an injectable anti-obesity agent, most prominently co-administered with the GLP-1 agonist semaglutide. In phase III randomized trials, the cagrilintide-semaglutide combination produced significant and clinically relevant body-weight reductions versus placebo, with more participants reaching weight-loss targets of 5% or more up to 30% or more [1], and in adults with type 2 diabetes it also markedly improved glycemic control, with 73.5% reaching an HbA1c of 6.5% or less versus 15.9% on placebo [2]. Earlier phase II dose-finding work established its activity as a once-weekly weight-management agent both alone and combined with semaglutide [3,4]. The main caveat is tolerability: gastrointestinal adverse events such as nausea, vomiting, and diarrhea were substantially more common than with placebo, though mostly transient and mild-to-moderate [1,2]. Evidence comes largely from sponsor-affiliated trials, and it is investigational rather than an approved standalone product.

Sources

  1. 1. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity The New England journal of medicine, 2025.
  2. 2. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes The New England journal of medicine, 2025.
  3. 3. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial Lancet (London, England), 2021.
  4. 4. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial Lancet (London, England), 2023.

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