Library / Weight and metabolic

Cagrilintide

Also known as CagriSema (with semaglutide), NN9838

Human trials

Investigational long acting amylin analogue peptide, studied alone and combined with semaglutide for obesity and type 2 diabetes in phase 3 trials.

Not an approved medicine. Cagrilintide is not an approved medicine for this use in Australia or the United States. This page summarises published research for information only. It is not a recommendation to use Cagrilintide, and VialOwl does not sell or supply it.

Background

A long acting synthetic analogue of amylin, a hormone made by the pancreas, developed by Novo Nordisk. It has been studied on its own and combined with semaglutide (CagriSema) in phase 2 and phase 3 trials since the late 2010s.

How it is thought to work

It activates amylin and calcitonin receptors, which increases fullness after eating and reduces food intake. It is designed to last a week so it can be injected once weekly.

What is claimed, and the evidence

Claim	Evidence	Notes
Weight loss when combined with semaglutide (CagriSema)	Human trials	Phase 3 REDEFINE 1 (n = 3,417): about 20% average weight loss over 68 weeks vs 3% with placebo. REDEFINE 2 in type 2 diabetes: 13.7% vs 3.4%. Not yet approved.
Weight loss on its own	Human trials	Phase 2 (n = 706): 6 to 11% average weight loss at 26 weeks vs 3% with placebo.
Blood sugar control in type 2 diabetes (with semaglutide)	Human trials	REDEFINE 2: 73.5% reached HbA1c of 6.5% or less vs 15.9% with placebo.

Side effects

Effect	How often	Notes
Nausea, vomiting, diarrhoea, constipation and abdominal pain	Common	Gastrointestinal effects in 80% with CagriSema vs 40% with placebo in REDEFINE 1; mostly mild to moderate and temporary.
Injection site reactions	Common	Among the most frequent adverse events in the phase 2 monotherapy trial.
Stopping treatment because of side effects	Uncommon	About 4% stopped for adverse events in the phase 2 monotherapy trial.

Warnings

Investigational only; not approved by the TGA or FDA, and the FDA says it cannot be used in compounding.
Trial participants were closely monitored; research grade products sold online are not the trial drug. Unapproved products bought online are not checked by any regulator for purity, sterility or strength; they may be contaminated, underdosed, overdosed or contain a different substance to the label.

Phase 3 trials

REDEFINE 1

Phase 3a, Completed, published. 3,417 participants, 68 weeks with a 16 week step up. NCT05567796

Population: Adults with BMI of 30 or more, or 27 or more with a related condition, without diabetes.
Arms: Cagrilintide 2.4 mg with semaglutide 2.4 mg weekly; Semaglutide 2.4 mg weekly; Cagrilintide 2.4 mg weekly; Placebo
Primary outcome: Percentage change in body weight, combination against placebo.
Results: Body weight changed by minus 20.4% on the combination against minus 3.0% on placebo. Results for cagrilintide alone are not in the abstract.
Safety: Gastrointestinal adverse events 79.6% against 39.9%. Discontinuation for adverse events is not given in the abstract.
Source: Garvey WT et al. N Engl J Med 2025;393:635-47.

Doses in these trials were given under medical supervision.

Regulatory status

Australia: Not included on the ARTG (unapproved). Not specifically listed in the Poisons Standard (June 2026).
United States: Not FDA approved. A combination with semaglutide (CagriSema) was submitted to the FDA in December 2025 (decision Not verified). FDA states cagrilintide cannot be used in compounding.

Sources

Also in Weight and metabolic

From the VialOwl library, reviewed 26 September 2026. For education and general information. It is not medical advice and not a recommendation to use Cagrilintide.