Cagrilintide

Not FDA-approved Evidence grade B — human randomised trials, not approved for that use Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: NN9838, CagriSema (with semaglutide), Cagri.

Regulatory status

Not FDA-approved. Novo Nordisk announced an NDA for CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) for weight management on 18 Dec 2025; still investigational and under FDA review per that announcement [5]. An FDA warning letter of 31 Mar 2026 to an online seller treated 'research' cagrilintide as an unapproved new drug intended for human use [6].

What it is

Long-acting amylin analogue (investigational; developed mainly in fixed combination with semaglutide as CagriSema).

An investigational once-weekly injected analogue of amylin, a pancreatic satiety hormone, from Novo Nordisk. Studied alone and, mostly, combined with semaglutide 2.4 mg (CagriSema) for weight management; not approved anywhere.

What the published research shows

Phase 2 dose-finding RCT of cagrilintide alone (706 randomised, 26 weeks); phase 3 REDEFINE RCTs of the CagriSema combination (REDEFINE 1: 3,417 adults, 68 weeks); no approval.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

Weight management without diabetes (phase 2 trial, Lau 2021): Once-weekly SC cagrilintide 0.3, 0.6, 1.2, 2.4 or 4.5 mg (escalation up to 6 weeks) for 26 weeks: mean weight loss 6.0-10.8 % versus 3.0 % with placebo and 9.0 % with liraglutide 3.0 mg daily.
Combination with semaglutide (phase 1b trial, Enebo 2021): 96 healthy adults with BMI 27-39.9; cagrilintide 0.16-4.5 mg plus semaglutide 2.4 mg weekly, co-escalated every 4 weeks over 16 weeks; week-20 weight loss 15.4-17.1 % at 1.2-4.5 mg versus 8.0-9.8 % with semaglutide plus placebo.
Overweight or obesity without diabetes (phase 3 REDEFINE 1): 3,417 adults; cagrilintide 2.4 mg + semaglutide 2.4 mg weekly for 68 weeks: mean weight change -20.4 % versus -3.0 % with placebo.
Overweight or obesity with type 2 diabetes (phase 3 REDEFINE 2): 1,206 adults; cagrilintide 2.4 mg + semaglutide 2.4 mg weekly for 68 weeks: mean weight change -13.7 % versus -3.4 % with placebo.

Mechanism, as reported

Mimics amylin, which promotes fullness; combining it with a GLP-1 agonist adds a second, separate appetite pathway. Long-acting enough for weekly dosing.

Practical record

Elimination half-life: 177.0 h (confidence: medium). Phase 1b trial (with semaglutide 2.4 mg): cagrilintide half-life 159-195 h across 0.16-4.5 mg, median tmax 24-72 h. The app uses 177 h, the midpoint of that range.
Studied routes: subcutaneous.
Typical supply: No approved product; investigational trial drug only. Sold illegally online as 'research' vials, which FDA treats as unapproved new drugs.

Safety signals on record

Reported adverse events: Mainly gastrointestinal (nausea, constipation, diarrhoea) and injection-site reactions; in phase 2, GI events in 41-63 % on cagrilintide versus 32 % on placebo. With semaglutide in REDEFINE 1, GI events affected 79.6 % versus 39.9 % on placebo, mostly transient and mild to moderate.
Contraindications: None established (no label).
Interactions: None documented. Combined dosing did not change semaglutide exposure in the phase 1b trial.
Notes: Unapproved: any product outside a trial is unregulated, with unknown identity, purity and dose.

Sources

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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