PMID-34798060 – Cagrilintide Phase 2 Weight Management Trial
Lau DCW, Erichsen L, Francisco-Ziller NM, Saturni S, Skovgaard D, Syed SK, Vester-Andersen MK, Wieloch M, Woodward RM. 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. 2021;398(10317):2160-2172.
Quick Reference
| Property | Value |
|---|---|
| PMID | 34798060 |
| DOI | 10.1016/S0140-6736(21)01751-7 |
| Year | 2021 |
| Journal | The Lancet |
| Study Type | RCT |
| Evidence Level | II |
| Sample | 706 adults with overweight/obesity (BMI >=27) |
| Peptide(s) Studied | Cagrilintide |
Key Findings
- 706 participants randomized to cagrilintide (0.3, 0.6, 1.2, 2.4, or 4.5 mg weekly), liraglutide 3.0 mg daily, or placebo
- Mean weight loss from baseline: cagrilintide 6.0%-10.8% (dose-dependent) vs placebo 3.0%
- Cagrilintide 4.5 mg produced 10.8% weight loss at 26 weeks
- Cagrilintide 2.4 mg produced 9.0% weight loss — comparable to liraglutide 3.0 mg (9.0%)
- Most common adverse events: GI (nausea, constipation, diarrhea) — typical of amylin analogs
- Injection site reactions occurred but were generally mild
Study Design
Multicentre, randomised, double-blind, placebo-controlled and active-controlled (liraglutide 3.0 mg), dose-finding phase 2 trial. 26-week treatment period plus 6-week follow-up. Primary endpoint: percentage change in body weight from baseline to week 26.
Limitations
- 26-week treatment duration; long-term effects unknown
- Active comparator was liraglutide (not semaglutide, the current standard)
- Population was relatively healthy (excluded T2D)
- Industry-sponsored (Novo Nordisk)
Clinical Relevance
Pivotal dose-finding study establishing cagrilintide as a novel weight loss agent via amylin receptor agonism — a distinct mechanism from GLP-1 agonists. The comparable efficacy to liraglutide at the highest dose and the complementary mechanism led to the development of CagriSema (cagrilintide + semaglutide combination), which represents a new paradigm of dual-pathway obesity treatment.
Related
#research #RCT #cagrilintide #evidence-level-II