Cagrilintide
Also called NNC0174-0833, CagriSema (when co-formulated or co-administered with semaglutide)
Research and education only. Not medical advice. Talk to a doctor.
In 30 seconds
A long-acting, lab-made version of amylin, a hormone made by the pancreas.[1]
Phase 3 trials are running; REDEFINE 1 enrolled 3,417 adults.[3]
Not FDA-approved. All 45 registered trials are run by Novo Nordisk.[6][10]
How far has the research gotten?
People in its biggest studies
How many people each study enrolled, as reported.Research over time
Papers on PubMed each year that mention Cagrilintide.31 papers in 2025Cagrilintide given together with semaglutide. The pair is being tested in large trials.[3]
What studies used
What each paper reports. A record of published research, not a recommendation.Safety, blood levels and weight and glucose effects of cagrilintide given with semaglutide.
Lancet · 2021 · PubMed 33894838What the paper reports
Once-weekly subcutaneous cagrilintide 0.16, 0.30, 0.60, 1.2, 2.4 or 4.5 mg (or placebo), each with once-weekly subcutaneous semaglutide 2.4 mg; doses co-escalated every 4 weeks over 16 weeks, then 4 weeks at target dose
Who: human (adults aged 18-55 with BMI 27.0-39.9 kg/m2, otherwise healthy; 96 randomised)How different doses of cagrilintide alone affected body weight, side effects and tolerability compared with placebo and liraglutide.
Lancet · 2021 · PubMed 34798060What the paper reports
Once-weekly subcutaneous cagrilintide 0.3, 0.6, 1.2, 2.4 or 4.5 mg for 26 weeks (including up to 6 weeks of dose escalation); comparators once-daily liraglutide 3.0 mg or placebo
Who: human (706 adults without diabetes with overweight or obesity assigned to cagrilintide)A phase 3a trial comparing weight change with the cagrilintide-semaglutide combination versus placebo over 68 weeks.
N Engl J Med · 2025 · PubMed 40544433What the paper reports
Cagrilintide 2.4 mg plus semaglutide 2.4 mg, semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone, or placebo, for 68 weeks with lifestyle intervention (dosing frequency not stated in abstract)
Who: human (3417 adults without diabetes; REDEFINE 1)Whether specific brain amylin receptor subtypes are needed for cagrilintide's effect on body weight and food intake in mice.
EBioMedicine · 2025 · PubMed 40609154What the paper reports
3 nmol/kg cagrilintide subcutaneously, SID, for 3 weeks (comparator salmon calcitonin 150 nmol/kg)
Who: mouse (wild-type and RAMP1/3 knockout, high-fat diet)What it is, in full 4
Cagrilintide is a man-made version of amylin, a hormone made by the pancreas, developed by Novo Nordisk scientists who attached a lipid group to make it long-acting, whereas the older amylin drug pramlintide needs three injections a day[1].
Because natural amylin is linked to feeling full, cagrilintide is being tested as a once-weekly injection for weight management in adults with overweight or obesity[2].
It is also being studied together with the GLP-1 drug semaglutide, a pairing called CagriSema, including in a large phase 3 trial[3].
In a mouse study, its effect on body weight depended on two brain amylin receptor subtypes, and the authors describe it as acting on both amylin and calcitonin receptors[5].
Regulatory details 3
A search of FDA's Drugs@FDA data through openFDA (data last updated 2026-10-02) returned no application containing cagrilintide, alone or in combination.[6]
Checked 2026-10-06Cagrilintide does not appear in any category of FDA's list of bulk drug substances nominated for 503A compounding (updated May 14, 2026).[9]
Checked 2026-10-06The 2026 List (in effect from 1 January 2026) does not name cagrilintide; its S0 section bans at all times any drug not covered elsewhere on the List that has no current government approval for human therapeutic use.[8]
Checked 2026-10-06Human trials on ClinicalTrials.gov
As of 2026-10-06, ClinicalTrials.gov returns 45 records for cagrilintide, all sponsored by Novo Nordisk A/S (17 phase 1, 6 phase 2, 22 phase 3; 25 completed, 11 recruiting, 7 active but not recruiting, 2 withdrawn)[10].
All sources 11
- Kruse T et al. Development of Cagrilintide, a Long-Acting Amylin Analogue. J Med Chem 2021PubMed (NLM)
- Lau DCW et al. Once-weekly cagrilintide for weight management (phase 2). Lancet 2021PubMed (NLM)
- Garvey WT et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1). N Engl J Med 2025PubMed (NLM)
- Enebo LB et al. Cagrilintide with semaglutide 2.4 mg, phase 1b trial. Lancet 2021PubMed (NLM)
- Carvas AO et al. Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3. EBioMedicine 2025PubMed (NLM)
- openFDA Drugs@FDA search for cagrilintide (no matches)U.S. FDA (openFDA)
- DailyMed label search for cagrilintide (0 results)DailyMed (NLM)
- World Anti-Doping Code International Standard: Prohibited List 2026World Anti-Doping Agency
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (updated May 14, 2026)U.S. FDA
- ClinicalTrials.gov search: cagrilintideClinicalTrials.gov (NLM)
- ClinicalTrials.gov record NCT05804162 (lists cagrilintide as NNC0174-0833 A)ClinicalTrials.gov (NLM)
Tap any purple number to open the source it came from.
Written from the sources above and checked on the date shown. Sources can be incomplete or out of date, and summaries can contain mistakes: read the source. See the terms.