NCT05394519 (REDEFINE 2) is a Phase 3 clinical trial of Cagrilintide in Overweight, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT05394519?

NCT05394519 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT05394519?

Interventions in NCT05394519: Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide.

What condition does NCT05394519 study?

NCT05394519 studies Overweight, Obesity, Type 2 Diabetes Mellitus.

Is NCT05394519 still recruiting?

NCT05394519 is currently completed. Last updated 28 January 2026.

Last reviewed 2026-01-28 · How we verify

NCT05394519: REDEFINE 2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Completed Phase 3 Last updated 28 January 2026

What this trial tests

Phase 3 trial testing Cagrilintide in Overweight in 1,200 participants. Completed in 3 February 2025.

Timeline

1 February 2023

Primary endpoint
28 January 2025

3 February 2025

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,200
Start date	1 February 2023
Primary completion	28 January 2025
Estimated completion	3 February 2025
Sites	179 locations across Germany, United States, Japan, Puerto Rico, Thailand, India, Austria, Hungary

Drugs / interventions tested

Cagrilintide — full drug profile →
Semaglutide (semaglutide) — full drug profile →
Placebo cagrilintide — full drug profile →
Placebo semaglutide — full drug profile →

Conditions studied

Overweight — all drugs for Overweight →
Obesity — all drugs for Obesity →
Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Overweight or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacotherapy of obesity: an update on the available medications and drugs under investigation.
Chakhtoura M, Haber R, Ghezzawi M, Rhayem C, et al · · 2023 · cited 260× · PMID 36992862 · DOI 10.1016/j.eclinm.2023.101882
What is the pipeline for future medications for obesity?
Melson E, Ashraf U, Papamargaritis D, Davies MJ. · · 2025 · cited 147× · PMID 38302593 · DOI 10.1038/s41366-024-01473-y
Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management.
Sinha R, Papamargaritis D, Sargeant JA, Davies MJ. · · 2023 · cited 66× · PMID 36750526 · DOI 10.7570/jomes22067
Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.
Davies MJ, Bajaj HS, Broholm C, Eliasen A, et al · · 2025 · cited 52× · PMID 40544432 · DOI 10.1056/nejmoa2502082
New therapies for obesity.
Papamargaritis D, le Roux CW, Holst JJ, Davies MJ. · · 2024 · cited 41× · PMID 36448672 · DOI 10.1093/cvr/cvac176
Amylin, Another Important Neuroendocrine Hormone for the Treatment of Diabesity.
Eržen S, Tonin G, Jurišić Eržen D, Klen J. · · 2024 · cited 23× · PMID 38338796 · DOI 10.3390/ijms25031517
Glucagon-like peptide-1 receptor agonists to expand the healthy lifespan: Current and future potentials.
Kreiner FF, von Scholten BJ, Kurtzhals P, Gough SCL. · · 2023 · cited 20× · PMID 37191234 · DOI 10.1111/acel.13818
New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2023.
Tamargo J, Agewall S, Borghi C, Ceconi C, et al · · 2024 · cited 13× · PMID 38379024 · DOI 10.1093/ehjcvp/pvae013

Verify or expand the search:

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 Overweight

Currently open trials in the same condition.

NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT07472881 — Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women · NA · recruiting
NCT07465965 — A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults · Phase 1 · recruiting
NCT07407348 — A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the · Phase 1 · recruiting
NCT07400653 — A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) · Phase 3 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05394519 (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: 28 January 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/NCT05394519.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing