Cagrilintide

What is cagrilintide?

Amylin is a hormone released from the pancreas that produces a feeling of fullness. ^[3] Cagrilintide is a long-acting synthetic human analog of this hormone; according to the REDEFINE 1 paper, it binds three amylin receptors and one calcitonin receptor and changes appetite regulation through direct effects in the brain. The same paper describes amylin as a satiety hormone involved in the central regulation of food intake, body weight and blood sugar. ^[1]

Cagrilintide is being developed not mainly as a stand-alone drug but together with the GLP-1 receptor agonist semaglutide. The development name of the combination, in which the two components are given at fixed doses in the same pen, is CagriSema. The rationale is the assumption that different but complementary mechanisms could produce more weight loss than a single drug. ^[1] In this respect it differs from single-molecule multi-agonists such as retatrutide, which stimulates GIP and glucagon receptors along with GLP-1, or tirzepatide, which acts on GIP and GLP-1 receptors; the general features of the class: GLP-1 agonists.

All of the phase 2 and phase 3 studies named below were funded by the manufacturer, and company employees were among the authors. In REDEFINE 1, the study design, protocol and statistical analyses were also the responsibility of the sponsor company. ^{[1] [2] [3] [5]}

Is cagrilintide approved? What is its status in Türkiye?

United States: The FDA page on unapproved GLP-1 drugs (content updated October 1, 2026) states that, under federal law, retatrutide and cagrilintide cannot be used in compounded (pharmacy-prepared) drugs, are not components of an approved drug, and have not been found safe and effective for any condition. ^[7] The FDA’s 2026 novel drug approvals list (content updated October 9, 2026) includes neither cagrilintide nor the cagrilintide–semaglutide combination. ^[8]

Türkiye: The Licensed Human Medicinal Products List of TİTCK (Turkish Medicines and Medical Devices Agency) dated October 16, 2026 contains no product with cagrilintide. ^[9] Two provisions in the legislation are directly relevant:

• Article 3 of Law No. 1262 on Pharmaceutical and Medicinal Preparations (İspençiyari ve Tıbbi Müstahzarlar Kanunu) requires Ministry permission before domestically produced medicinal preparations are placed on the market and before those produced abroad are imported. ^[10]
• Article 24 of Law No. 6197 on Pharmacists and Pharmacies (Eczacılar ve Eczaneler Hakkında Kanun) provides that medicines cannot be sold on the internet or in any other electronic medium. ^[11]

Sport: WADA’s 2026 Prohibited List does not name cagrilintide. However, class S0 prohibits at all times any pharmacological substance that is not covered in another section of the list and is not approved for human therapeutic use by any governmental health authority (for example, drugs under clinical development). ^[12] Until cagrilintide receives approval, it falls within the scope of this definition.

How effective is cagrilintide alone?

The most extensive data on cagrilintide alone come from a phase 2 dose-finding study conducted in 10 countries. Adults without diabetes with a BMI ≥30, or ≥27 with hypertension or dyslipidemia, received one of five cagrilintide doses, daily liraglutide or placebo (706 people on cagrilintide, 99 on liraglutide, 101 on placebo). At 26 weeks, in the analysis that assumes everyone adhered to treatment, weight loss was 6.0–10.8% in the cagrilintide groups and 3.0% with placebo; the highest dose produced somewhat more weight loss than liraglutide (10.8% versus 9.0%; p=0.03). Results were similar in the analysis that also counted those who stopped the drug. Participants were blinded between active treatment and placebo, but there was no blinding between the different active treatments. ^[3]

In the 302-person arm receiving cagrilintide alone in REDEFINE 1, the mean weight change at 68 weeks was −11.5%; in the same study, the semaglutide-alone arm showed −14.9% and the combination −20.4%. This arm was compared only with the combination; no formal test was made between cagrilintide alone and placebo. ^[1] In a 92-person phase 2 study in people with type 2 diabetes, weight change at 32 weeks with cagrilintide alone was −8.1% and HbA1c change was −0.9 points. ^[4]

What did REDEFINE 1 and REDEFINE 2 find?

Both phase 3a studies lasted 68 weeks, applied lifestyle support to all groups, and were published in the NEJM in 2025. Two different estimands were reported in both studies:

• Treatment-policy estimand (intention-to-treat approach): Those who stopped the drug and those who switched to another obesity treatment are counted in their own groups. This is the primary result.
• Trial-product estimand: Calculated on the assumption that everyone continued to use the drug as intended; the numbers are therefore larger. ^[1]

In REDEFINE 1, in the intention-to-treat analysis, 53.6% of the combination group lost at least 20% and 19.3% lost at least 30% (1.9% and 0.4% with placebo). Systolic blood pressure fell 9.9 mmHg with the combination and 3.2 mmHg with placebo (difference 6.7 mmHg; 95% CI 5.6–7.8); mean baseline blood pressure was 127 mmHg. Blood sugar returned to normal in 87.7% of those with prediabetes at baseline (32.2% with placebo). ^[1]

Dose adherence matters in reading the results. The protocol allowed delaying dose escalation or reducing the dose if there were side effects. At week 68, 57.4% of the combination group in REDEFINE 1 and 61.9% in REDEFINE 2 were on the target dose; the proportion still using the drug at week 68 in REDEFINE 1 was 88.2% with the combination and 75.9% with placebo. ^{[1] [2]} As limitations, the authors note that REDEFINE 1 participants were mostly women and white, that only 6.1% were overweight (BMI below 30), and that REDEFINE 2 had no separate single-drug arms. ^{[1] [2]}

In REDEFINE 5, conducted in Japan and Taiwan with 331 adults (24% with type 2 diabetes) with a BMI ≥27 and at least two, or a BMI ≥35 and at least one, obesity-related disease, the combination was compared with semaglutide alone. By the trial-product estimand, weight change at 68 weeks was −18.4% with the combination and −11.9% with semaglutide (difference 6.5 points; 95% CI 4.6–8.4); treatment discontinuation was 10% versus 6%. ^[6]

Blood sugar in type 2 diabetes

In a phase 2 study of 92 people with type 2 diabetes using metformin in the US, HbA1c fell by 2.2 points with the combination, 1.8 with semaglutide and 0.9 with cagrilintide at 32 weeks. The combination’s superiority over semaglutide was not statistically significant (difference 0.4 points; p=0.075); weight loss, however, was markedly greater with the combination (15.6% versus 5.1% and 8.1%). ^[4]

In the phase 3 REIMAGINE 2 study with 2,713 people in 30 countries, in people with type 2 diabetes using metformin (with or without an SGLT2 inhibitor), HbA1c fell by 1.91 points with the combination and by 1.75 points with semaglutide alone at the same target dose over 68 weeks (difference 0.16 points; 95% CI 0.05–0.27). This primary result was calculated with the estimand that assumes everyone adhered to treatment. ^[5] In REDEFINE 2, at week 68, HbA1c was 6.5% or lower in 73.5% of the combination group and 15.9% of the placebo group. ^[2]

How much of the weight loss came from fat?

In REDEFINE 1, in a prespecified subgroup (252 of 3,417 people, 7.4%), body composition was measured by DXA. In the combination group, fat mass fell by 17.0 kg and lean soft tissue mass by 8.4 kg; 67% of the loss came from fat and 33% from lean tissue. The authors state that the magnitude of lean tissue loss needs to be investigated separately and that this measurement gives no information about muscle quality or function. ^[1]

Side effects and discontinuation

• Gastrointestinal complaints: In REDEFINE 1, reported in 79.6% with the combination, 73.8% with semaglutide, 54.0% with cagrilintide and 39.9% with placebo; most were mild to moderate in severity. Nausea, diarrhea and vomiting peaked during the dose escalation period, while constipation remained constant afterward. ^[1]
• Discontinuation: Permanent discontinuation due to an adverse event was 5.9% with the combination and 3.5% with placebo in REDEFINE 1; 8.4% versus 3.0% in REDEFINE 2. ^{[1] [2]}
• Gallbladder and injection site: In REDEFINE 1, gallbladder-related disorders were 4.1% with the combination and 1.0% with placebo; injection site reactions were 16.9% with cagrilintide alone, 12.2% with the combination and 3.0% with placebo. ^[1]
• Serious events: In REDEFINE 1, serious adverse events were 9.8% with the combination and 6.1% with placebo; two deaths (suicide and cancer) were reported in the combination group. In REDEFINE 2, four deaths (suicide, cancer, sudden cardiac death, and another non-cardiac cause) were reported in the combination group, and there were no deaths in the placebo group. ^{[1] [2]}
• Hypoglycemia (type 2 diabetes): In REDEFINE 2, clinically significant (level 2) hypoglycemia occurred in 6.0% with the combination and 3.3% with placebo; both people who experienced severe (level 3) hypoglycemia were using a sulfonylurea. ^[2]

The primary and confirmatory endpoints of REDEFINE 1 are weight, waist circumference, systolic blood pressure and physical function; the study was not designed to measure events such as heart attack, stroke or death. ^[1] When the paper was published, the extension phase of REDEFINE 1 was ongoing; safety data beyond 68 weeks are not in this paper. ^[1]

Is cagrilintide more effective than semaglutide or tirzepatide?

According to the published phase 3 data, the combination produced more weight loss than semaglutide alone (intention-to-treat difference of 5.5 points in REDEFINE 1; trial-product difference of 6.5 points in REDEFINE 5). ^{[1] [6]} The results of a study directly comparing it with tirzepatide had not been published in a peer-reviewed journal as of October 2026. Placing the averages of different studies side by side is not a reliable comparison, because participant characteristics, duration and estimand differ. For the evidence on licensed options: Semaglutide, Tirzepatide.

Evidence table: claim, population and limits

Limits of this guide

This page summarizes the published peer-reviewed studies on cagrilintide and the statements of regulatory bodies. It contains no dose, administration, storage or sourcing information and recommends use under no circumstances. The study results were obtained in adults selected by entry criteria and under physician monitoring within a protocol. ^[1] If a licensing process is completed, the product information may contain warnings and limits different from the study results on this page.