Cagrilintide: what it is, what the studies show and where it stands
Cagrilintide is a long-acting amylin analogue under study as a once-weekly injection for weight management, on its own and combined with semaglutide. The combination is called CagriSema.
At a glance
US Not approved, in trials
Canada Not authorized
Group Weight loss and metabolic
Sources 11
Checked 10 Oct 2026What is Cagrilintide?
Cagrilintide is a long-acting amylin analogue under study as a once-weekly injection for weight management, on its own and combined with semaglutide. The combination is called CagriSema. [1]
Other names: NNC0174-0833.
How it has been given to people: subcutaneous injection, once weekly.
Looking for doses? Cagrilintide dosage chart and vial math
Is Cagrilintide approved in the US and Canada?
United States: Not FDA approved. FDA states cagrilintide is not a component of an FDA-approved drug and cannot be used in compounding. [7]
Canada: No cagrilintide product is in the Health Canada Drug Product Database. [10]
Both were checked on 10 Oct 2026 against the regulators' own product databases.
Which approved products contain Cagrilintide?
No approved medicine containing Cagrilintide was found in the US or Canada. Anything sold under this name is not a regulated product, so there is no label to check a dose against.
What human studies of Cagrilintide exist?
The 4 findings listed here: 3 from randomized human trials and 1 from smaller or observational human studies.
Cagrilintide alone, 26 weeks: weight loss was greater than placebo at every dose from 0.3 mg to 4.5 mg. The percentages are in the abstract and are not copied here (see not_found). [1]
With semaglutide, in adults without diabetes: mean weight change at 68 weeks was -20.4% on the combination against -3.0% on placebo. [3]
With semaglutide, in adults with type 2 diabetes: mean weight change at 68 weeks was -13.7% on the combination against -3.4% on placebo. [4]
Single-dose studies found no clinically relevant change in cagrilintide blood levels in people with kidney or liver impairment. [6]
What are the side effects of Cagrilintide?
Reported in human studies or on a label:
- Cagrilintide alone (phase 2): the most frequent adverse events were stomach and bowel problems such as nausea, constipation and diarrhea, and reactions where the injection was given. [1]
- With semaglutide (REDEFINE 1): stomach and bowel events affected 79.6% on the combination and 39.9% on placebo, mostly short-lived and mild to moderate. [3]
- With semaglutide in type 2 diabetes (REDEFINE 2): stomach and bowel events were reported by 72.5% on the combination and 34.4% on placebo. [4]
What is the half-life of Cagrilintide?
159 to 195 hours, about 6.6 to 8.1 days, measured in a phase 1b trial where it was given with semaglutide 2.4 mg. [5]
How does Cagrilintide compare with others in its group?
These are the peptides filed under weight loss and metabolic. The last column says whether a randomized human trial is on record for each.
| Peptide | US | Canada | Half-life | Randomized human trial |
|---|---|---|---|---|
| Retatrutide | Not approved, in trials | Not authorized | About 6 days, from a 12-week phase 1b trial of once-weekly dosing in people with type 2 diabetes (72 enrolled). | Yes |
| Tirzepatide | Approved, prescription | Authorized, prescription | About 5 days. | Yes |
| Semaglutide | Approved, prescription | Authorized, prescription | About 1 week. | Yes |
| Cagrilintide | Not approved, in trials | Not authorized | 159 to 195 hours, about 6.6 to 8.1 days, measured in a phase 1b trial where it was given with semaglutide 2.4 mg. | Yes |
| AOD-9604 | Not approved | Not authorized | Not found | Yes |
| 5-Amino-1MQ | Not approved | Not authorized | Not found | No |
| SLU-PP-332 | Not approved | Not authorized | Not found | No |
| HGH Fragment 176-191 | Not approved | Not authorized | Not found | No |
What could not be found
These were searched for and did not turn up. They are listed so a missing number is not mistaken for a hidden one.
- No approved label anywhere, so no official contraindications, interaction list, missed-dose rule or storage instructions.
- Phase 2 weight-loss percentages by dose are not copied: the Lancet abstract [1] prints its decimals with a raised dot, which cannot be quoted word for word in an ASCII-only file. Read them at the PubMed link.
- The REDEFINE 1 abstract gives no result for the arm that took cagrilintide alone.
- The dose used in the cagrilintide-only phase 3 trial [11] is not stated in its registry record.
- Which regulators have received a CagriSema application, and when. Only the company pipeline page was found, and it does not say.
Cagrilintide questions
Is Cagrilintide approved in the US?
Not FDA approved. FDA states cagrilintide is not a component of an FDA-approved drug and cannot be used in compounding.
Is Cagrilintide authorized in Canada?
No cagrilintide product is in the Health Canada Drug Product Database.
What is the half-life of Cagrilintide?
159 to 195 hours, about 6.6 to 8.1 days, measured in a phase 1b trial where it was given with semaglutide 2.4 mg.
Has Cagrilintide been tested in a randomized human trial?
Yes. At least one randomized human trial is listed on this page.
Sources
Each one was opened on 10 Oct 2026 and matched to the line it supports.
- Lau DCW et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet 2021. PubMed 34798060. Trial NCT03856047.
- ClinicalTrials.gov NCT03856047: Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity. clinicaltrials.gov. Trial NCT03856047.
- Garvey WT et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med 2025. PubMed 40544433. Trial NCT05567796.
- Davies MJ et al. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med 2025. PubMed 40544432. Trial NCT05394519.
- Enebo LB et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet 2021. PubMed 33894838. Trial NCT03600480.
- Nielsen MJF et al. Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Clin Pharmacokinet 2026. PubMed 42228334.
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 10/01/2026) fda.gov.
- Drugs@FDA via openFDA: search for active ingredient cagrilintide (no match) api.fda.gov.
- ClinicalTrials.gov search: studies with cagrilintide as an intervention (44 found) clinicaltrials.gov.
- Health Canada Drug Product Database: search for active ingredient cagrilintide (no match) health-products.canada.ca.
- ClinicalTrials.gov NCT07220642: Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide clinicaltrials.gov. Trial NCT07220642.
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Cagrilintide dosageWeight loss and metabolicStatus in Canada
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