Recruiting
Phase 3

CagriSema vs. Semaglutide

Sponsor:

Novo Nordisk A/S

Code:

NCT07564414

Conditions

Obesity

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cagrisema

Semaglutide

Study Details

Brief summary:

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Conditions

Obesity

Type 2 Diabetes

Study ID

NCT07564414

Start date

May 21, 2026

Status verified date

Aug, 2026

Completion date

Apr 19, 2028

Anticipated

Primary completion date

Feb 23, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria :

  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Age 18 years or above at the time of signing the informed consent.
  • BMI≥ 35.0 kg/m\^2.
  • Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.

Exclusion Criteria:

  • A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records.
  • Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

Study Design

Enrollment

2500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cagrisema - dose level 1

Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.

active comparator: Cagrisema - dose level 2

Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.

active comparator: Semaglutide

Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.

Interventions

Cagrisema

Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.

Semaglutide

Semaglutide will be administered subcutaneously.

Primary outcome measure

  • Relative change in body weight [ Time Frame: From randomisation (week 0) to end of treatment (week 72) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

C-Health Partners

Recruiting

Calgary, Alberta, Canada, T2V 4J2

Kelowna Health and Memory Centre Ltd.

Recruiting

Kelowna, British Columbia, Canada, V1Y 5A8

Medical Arts Health Research Group_Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y4N7

Ocean West Research Clinic

Recruiting

Surrey, British Columbia, Canada, V3Z 2N6

Hilltop Medical Clinic

Recruiting

Surrey, British Columbia, Canada, V4A 0C1

Dr. M.B. Jones Inc

Recruiting

Victoria, British Columbia, Canada, V8V 4A1

G.A. Research Associates Ltd.

Recruiting

Moncton, New Brunswick, Canada, E1G 1A7

Nova Scotia Hlth Halifax

Recruiting

Halifax, Nova Scotia, Canada, B3H1V7

Care Access Cape Breton

Recruiting

Sydney, Nova Scotia, Canada, B1M 0A1

Centricity Research Brampton Endocrinology

Recruiting

Brampton, Ontario, Canada, L6S 0C6

Hamilton Medical Research Group

Recruiting

Hamilton, Ontario, Canada, L8L 5G4

Premier Clinical Trial Research Network (PCTRN)

Recruiting

Hamilton, Ontario, Canada, L8L 5G4

Wharton Medical Clinic Clinical Trials (Hamilton)

Recruiting

Hamilton, Ontario, Canada, L8L 5G8

Milestone Research

Recruiting

London, Ontario, Canada, N5W 6A2

Bluewater Clin Res Group Inc

Recruiting

Sarnia, Ontario, Canada, N7T 4X3

Diabetes Heart Research Centre

Recruiting

Toronto, Ontario, Canada, M6G 1M2

Centre Medical Acadie

Recruiting

Montreal, Quebec, Canada, H4N 2W2

Centricity Res Pointe-Claire

Recruiting

Pointe-Claire, Quebec, Canada, H9R 4S3

Diex Recherche Quebec

Recruiting

Québec, Canada, G1V 4T3

Alpha Recherche Clinique - Lebourgneuf

Recruiting

Québec, Canada, G2J 0C4

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-31.