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NCT06221969
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
Phase 3 trial testing Cagrilintide in Type 2 Diabetes in 1,024 participants. Completed in 6 April 2026.
4 March 2026
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,024 |
| Start date | 16 January 2024 |
| Primary completion | 4 March 2026 |
| Estimated completion | 6 April 2026 |
| Sites | 196 locations across Taiwan, United States, Colombia, India, South Africa, Australia, Argentina, Canada |
Drugs / interventions tested
- Cagrilintide — full drug profile →
- Semaglutide (semaglutide) — full drug profile →
- Tirzepatide (TIRZEPATIDE) — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
18 and older, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2024.
Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2025 · cited 6× · PMID 40058879 · DOI 10.1093/ehjcvp/pvaf012
Verify or expand the search:
- PubMed search for NCT06221969
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cagrilintide
Trials testing the same drug.
- NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting
- NCT07411560 — A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in Peopl · Phase 1 · recruiting
- NCT07253285 — A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight · Phase 3 · recruiting
- NCT07220759 — Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide · Phase 3 · active not recruiting
- NCT07220642 — Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide · Phase 3 · active not recruiting
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other Novo Nordisk A/S trials
Trials by the same sponsor.
- NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
- NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
- NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
- NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
- NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06221969 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
- Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06221969.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing