GLP-1InvestigationalEvidence tier: Human RCT

Cagrilintide

Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.

FDA status

Investigational

Investigational. No FDA-approved cagrilintide product. It is being studied in clinical trials.

ClinicalTrials.gov: cagrilintide

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 4/5. 72 PubMed citations indexed.

Products sold as "research use only" are not approved for human use. FDA warning.

Cagrilintide in the literature

Cagrilintide is a long-acting fatty-acid conjugated amylin analog designed to activate amylin receptors (AMY1, AMY2, AMY3) in the hypothalamus and brainstem, producing satiety signals that are complem

What the literature studies

GLP-1 Research

Evidence tier

Human RCT

Compounding record

Status not verified

Confidence
4/5

Regulatory record

Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source not verified; no checked date is assigned.

Regulatory context and verification limits are documented below.

Questions

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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Cagrilintide is Novo Nordisk's long-acting amylin analog; combined with semaglutide as CagriSema it produced 20.4% weight loss in REDEFINE 1, Novo filed with FDA Dec 18 2025, and Novo expects a decision in Q4 2026.

What it is

A once-weekly long-acting amylin analog [R3].

Legal / FDA status (as of Oct 27 2026)

Not approved. CagriSema NDA submitted Dec 18 2025 [R3]; Novo says decision expected Q4 2026 and "CagriSema is not approved for use in the United States" [R4]. No FDA goal date is officially published.

Human evidence

  • Cagrilintide alone, phase 2 (26 wk): 6.0%-10.8% weight loss across doses vs 3.0% placebo [R1].
  • REDEFINE 1 (68 wk): CagriSema -20.4% vs -3.0% placebo [R2][R3].
  • REDEFINE 2 (T2D): -13.7% vs -3.4% [R5].

Animal / lab evidence

Human RCT data now outweigh preclinical work.

Risks and unknowns

REDEFINE 1: GI adverse events in 79.6% on CagriSema vs 39.9% on placebo, mainly transient [R2]. Gray-market products unverified.

What's coming

FDA decision on CagriSema expected Q4 2026 (Novo guidance) [R4].

Sources

  1. [R1] Lau DCW et al. 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;398:2160-2172. doi:10.1016/S0140-6736(21)01751-7
  2. [R2] Garvey WT et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1). NEJM 2025. doi:10.1056/NEJMoa2502081
  3. [R3] Novo Nordisk, Dec 18 2025. https://www.novonordisk-us.com/media/press-releases/novo-nordisk-cagrisema-fda-nda-submission.html
  4. [R4] Novo Nordisk, Oct 2026. https://www.novonordisk-us.com/media/press-releases/cagrisema-redefine1-weight-loss-women-menopause.html
  5. [R5] Davies MJ et al. REDEFINE 2. NEJM 2025. doi:10.1056/NEJMoa2502082

Last checked 2026-10-27

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