← All compounds · evidence tier first, by design

Evidence tier for each claimed use · ← established · unknown →
Use	E1	E2	E3	E4	E5	E6	E7	E8
E1 Weight management in adults with overweight or obesity, with or without type 2 diabetes (cagrilintide plus semaglutide, CagriSema)	E1
E2 Weight management in adults with overweight or obesity (cagrilintide alone)		E2

Class B · Investigational

Cagrilintide

Lipidated (fatty-acid acylated), long-acting analogue of human amylin with amino-acid substitutions; design described in Kruse et al., J Med Chem 2021. Full modified sequence not reproduced here because it was not verified against a regulator document.

Non-standard residues or modifications: no plain one-letter sequence

Also: CagriSema (fixed co-formulation with semaglutide) · Codes: NNC0174-0833

A synthetic, long-acting analogue of amylin, a pancreatic hormone involved in satiety, developed by Novo Nordisk for weight management, alone and in a fixed combination with semaglutide (CagriSema). It is investigational: no product containing it was found in the US, EU, UK, Canadian or Australian regulator databases checked on the retrieval date. Material sold online under this name is not the sponsor's product and is of unverified identity and purity.

US B investigational
EU B investigational
UK B investigational
CA B investigational
AU B investigational
JP ? not verified
CN ? not verified

01Regulatory status, by jurisdiction

Standing notice. This compound is an investigational drug. It is not approved in any jurisdiction. There is no lawful supply. Any material sold under this name is of unverified origin, and is neither manufactured nor tested to pharmaceutical standards.

Jurisdiction	Status	Detail and primary source
US	Investigational	No approved application. The openFDA Drugs@FDA endpoint returns no application with cagrilintide as an active ingredient (query: products.active_ingredients.name:CAGRILINTIDE*). Sponsored phase 3 trials are registered (e.g. NCT05567796, NCT07220642). Whether a marketing application is under FDA review was not verified from an FDA source. “No matches found!” openFDA Drugs@FDA API (FDA) · retrieved 2026-10-10
EU	Investigational	Absent from EMA's downloadable table of centrally authorised medicines (retrieved 2026-10-10) and absent from EMA's monthly lists of new medicines under CHMP evaluation for August, September and October 2026. “publishes an updated list of medicines for human use currently under evaluation” EMA: Medicines for human use under evaluation · retrieved 2026-10-10
UK	Investigational	A search of the MHRA products database index for 'cagrilintide' returned no authorised product documents. “Scientific reports about marketing authorisations for medicines” MHRA Products · retrieved 2026-10-10
CA	Investigational	The Health Canada Drug Product Database API returns no product with active ingredient cagrilintide (https://health-products.canada.ca/api/drug/activeingredient/?lang=en&type=json&ingredientname=cagrilintide returned an empty list). “The DPD contains product specific information on drugs approved for use in Canada.” Health Canada Drug Product Database (DPD) API Guide · retrieved 2026-10-10
AU	Investigational	The TGA Product and Consumer Medicine Information repository returns no documents for cagrilintide. Absence of a PI/CMI is strong but not conclusive evidence of no ARTG registration; the ARTG search itself could not be loaded. “Trade Names and Active Ingredients containing cagrilintide . 0 Documents available.” TGA Product and Consumer Medicine Information search · retrieved 2026-10-10
JP CN	Not yet verified from a primary source. No status is shown rather than an unsourced one.

Sport (WADA): Prohibited · class S0. “Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use” WADA source

02What the human evidence shows

Weight management in adults with overweight or obesity, with or without type 2 diabetes (cagrilintide plus semaglutide, CagriSema)

2published human RCTs

n/cpublished human trials

44registered studies

1with posted results

n/c: not counted here; see the cited review.

Two phase 3a placebo-controlled RCTs report consistent results over 68 weeks. In adults without diabetes (REDEFINE 1, 3417 randomised) mean body-weight change was -20.4% with the combination versus -3.0% with placebo. In adults with type 2 diabetes (REDEFINE 2, 1206 randomised) it was -13.7% versus -3.4%, with more participants reaching glycated haemoglobin of 6.5% or less. Gastrointestinal adverse events were common (79.6% versus 39.9% in REDEFINE 1). Neither trial's registry record had posted results on the retrieval date. Cardiovascular outcome data (REDEFINE 3) are not yet reported.

[1] Greater 68-week weight reduction with cagrilintide-semaglutide than placebo in adults without diabetes
[2] Greater 68-week weight reduction and glycaemic improvement than placebo in adults with type 2 diabetes

Registered-study counts: ClinicalTrials.gov intervention search “cagrilintide”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.

Weight management in adults with overweight or obesity (cagrilintide alone)

2published human RCTs

n/cpublished human trials

44registered studies

1with posted results

n/c: not counted here; see the cited review.

One adequately sized phase 2 dose-finding RCT (706 participants, 26 weeks) found greater mean weight reduction with every cagrilintide dose than with placebo, with gastrointestinal adverse events (mainly nausea) more frequent than with placebo. The phase 3a REDEFINE 1 trial included a cagrilintide-alone arm (302 participants) as a comparator, but its published primary comparison was the combination against placebo. Dedicated phase 3 monotherapy trials are registered and have not reported. Published results for cagrilintide alone beyond 68 weeks are absent.

[3] All cagrilintide doses produced greater 26-week weight reduction than placebo in adults with overweight or obesity; nausea was the most frequent adverse event
[1] Phase 3a RCT with a cagrilintide-alone comparator arm; primary analysis compared the combination with placebo over 68 weeks

Key registered trials

NCT	Title (as registered)	Phase	Status
NCT03856047	Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.	2	Completed
NCT05567796	A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight	3	Active, not recruiting
NCT05394519	A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight	3	Completed
NCT06131437	A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight	3	Completed
NCT05669755	REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels	3	Active, not recruiting
NCT07220642	Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide	3	Active, not recruiting

03Safety signals

S2Substantial controlled-trial safety data

There are no adequate human safety data. The absence of reported harm is not evidence of safety.

Gastrointestinal adverse events (nausea, vomiting, diarrhoea, constipation) [1]
Reported more often than placebo in the phase 2 monotherapy RCT and in the phase 3a combination RCTs; mostly transient and mild to moderate. No post-marketing data exist because no product is approved.

04What is unknown

No published phase 3 efficacy results for cagrilintide as a stand-alone product; dedicated monotherapy phase 3 trials have not reported
No cardiovascular outcome data; REDEFINE 3 has not reported
No safety data beyond the 68-week trial periods and no post-marketing surveillance, because no product is approved
No data of any kind on the identity, purity or sterility of material sold outside the sponsor's trials under the name cagrilintide
Effects in pregnancy and lactation are not established in humans

05Product quality

No independent purity results have been published for this compound yet. The purity programme will publish full methods and vendor-named results, passes and failures, once its protocol has had legal review.

06Citations

Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (2025). doi:10.1056/nejmoa2502081
Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (2025). doi:10.1056/nejmoa2502082
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 (2021). doi:10.1016/s0140-6736(21)01751-7

Every DOI is resolved against Crossref and every NCT number against ClinicalTrials.gov, title for title, before publication. Regulatory sources are cited inline above with a verbatim quote and retrieval date.

07Mechanism

Cagrilintide is a lipidated, long-acting analogue of the pancreatic hormone amylin. Endogenous amylin signalling is involved in satiety and the rate of gastric emptying.

Mechanism is placed last on purpose: a plausible mechanism is not evidence that a compound works in people.

Reviewed by OSMF research team (AI-assisted, source-verified) on 2026-10-10. Found an error? It goes in the corrections log: report it.