Cagrilintide
Cagrilintide is an experimental long-acting version of the hormone amylin, developed by Novo Nordisk. It is being studied alone and combined with semaglutide (as CagriSema) for obesity and type 2 diabetes, and is not approved anywhere.
Reference information, not medical advice. Enhanced Training Studio doesn't sell, supply or recommend any substance. Doses are left out on purpose: only a prescriber can set one. How this library is written.
What it is
Cagrilintide is an experimental peptide medicine developed by Novo Nordisk. It is a long-acting analogue of the hormone amylin [2]. It is being studied in two forms:
- CagriSema: a fixed combination of cagrilintide and the approved GLP-1 medicine semaglutide, given by injection under the skin [2].
- Cagrilintide alone: being studied as a separate treatment for obesity [3].
As of October 2026, neither form is approved in the UK, US or EU [1, 2]. Novo Nordisk submitted CagriSema to the FDA for weight management in December 2025, with a review expected during 2026 [2]. It should only be used within authorised clinical trials.
How it works
Cagrilintide acts like amylin, while semaglutide acts like the gut hormone GLP-1 [2]. The manufacturer describes the combination as targeting complementary pathways involved in obesity [2]. Semaglutide on its own increases feelings of fullness and reduces hunger and food intake [4]. How much each part adds to the combined effect, and the long-term effects of combining them, are still being studied.
Approved medical uses
None in people. The FDA states that cagrilintide is not approved for any condition [1]. CagriSema is not approved in the US or EU [2].
What the research shows
All of the large trials below were run by the manufacturer [2, 3].
- REDEFINE 1 enrolled 3,417 adults with obesity, or overweight with weight-related conditions, without diabetes. Over 68 weeks, people on CagriSema lost about 20% of body weight on average, compared with 3% on placebo. About 92% lost at least 5% of their weight, compared with about 32% on placebo [2].
- Cagrilintide alone was also tested in REDEFINE 1. People on cagrilintide by itself lost about 12% of body weight on average over 68 weeks, compared with about 2% on placebo [3]. This is less than with the combination [2, 3].
- REDEFINE 2 enrolled 1,206 adults with type 2 diabetes and obesity or overweight, followed for 68 weeks, and its results were published in the New England Journal of Medicine in 2025 [2].
- The manufacturer planned a dedicated phase 3 programme for cagrilintide alone, called RENEW [3].
Known risks and side effects
- Stomach and bowel effects: these were the main side effects. In REDEFINE 1, about 80% of people on CagriSema had stomach or bowel side effects, compared with about 40% on placebo [2]. With cagrilintide alone, nausea, vomiting, diarrhoea and constipation were the most common, and were mostly mild to moderate [3].
- Stopping because of side effects: about 6% of people on CagriSema stopped treatment because of side effects in REDEFINE 1, compared with 3.5% on placebo [2].
- Risks of the semaglutide component: semaglutide carries warnings about pancreatitis, gallbladder disease, kidney injury from dehydration, low blood sugar with insulin or sulfonylureas, worsening diabetic eye disease, and thyroid C-cell tumours in rodents [4]. These would be expected to apply to CagriSema, but its full safety profile will only be known once regulators finish their review.
- Unlicensed products: the FDA states that cagrilintide is not approved for any condition and cannot legally be used in compounding. It has also warned about unapproved drugs falsely labelled as not for human use [1]. The MHRA warns that prescription weight-loss medicines obtained outside registered pharmacies carry serious risks and may be contaminated [5].
- Sport: as a substance with no approval for human therapeutic use, cagrilintide falls under the World Anti-Doping Agency's S0 category of non-approved substances, which are prohibited at all times [6].
Blood tests commonly monitored
There are no official monitoring guidelines for cagrilintide because it is not an approved medicine. For semaglutide, the approved component of CagriSema, the product label mentions:
- Blood glucose: in people with diabetes, especially alongside insulin or sulfonylureas [4].
- Kidney function: in people with vomiting, diarrhoea or dehydration [4].
- Calcitonin: routine testing has uncertain value for detecting thyroid cancer [4].
- Lipase and amylase: may rise; the meaning without symptoms of pancreatitis is unclear [4].
If you and your doctor are monitoring treatment, Enhanced Training Studio keeps a private log on your phone: what you take and when, your blood test results over time, and how you feel. How tracking works.
Sources
- US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss. FDA, updated 2026. FDA: unapproved GLP-1 drugs
- Novo Nordisk. Novo Nordisk files for FDA approval of CagriSema, the first combination of GLP-1 and amylin analogues for weight management. Company announcement, December 2025. Novo Nordisk news
- Patient Care. Amylin injectable cagrilintide demonstrates weight loss of 11.8% in late-stage trial. MJH Life Sciences, September 2025. Patient Care Online
- US Food and Drug Administration / Novo Nordisk. Wegovy (semaglutide): prescribing information. DailyMed, US National Library of Medicine, revised 2026. DailyMed: Wegovy
- Medicines and Healthcare products Regulatory Agency. MHRA smashes major illicit weight loss medicine production facility in record seizure. GOV.UK, 2025. MHRA: illicit facility seizure
- World Anti-Doping Agency. The 2026 Prohibited List (S0 Non-approved substances), as published in the Dutch Treaty Series (Tractatenblad) 2026, no. 25. 2026 Prohibited List
Related
Last reviewed 7 October 2026. General information, not medical advice. Found a mistake? Email [email protected].