Recruiting
Phase 3

Cagrilintide

Sponsor:

Novo Nordisk A/S

Code:

NCT07745504

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cagrilintide

Placebo cagrilintide

Placebo semaglutide

Study Details

Brief summary:

The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.

Conditions

Overweight

Obesity

Study ID

NCT07745504

Start date

Aug 4, 2026

Status verified date

Sep, 2026

Completion date

Jul 6, 2027

Anticipated

Primary completion date

May 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • 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.
  • Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per square meter (kg/m\^2), or BMI >= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

Exclusion criteria:

  • History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D).
  • Previous dosing of marketed or non-marketed amylin-based compounds.
  • Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.

Study Design

Enrollment

285 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2

Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks.

experimental: Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1

Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.

placebo comparator: Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1

Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.

Interventions

Cagrilintide

Cagrilintide will be administered subcutaneously.

Placebo cagrilintide

Placebo matched to cagrilintide will be administered subcutaneously.

Placebo semaglutide

Placebo matched to semaglutide will be administered subcutaneously.

Primary outcome measure

  • Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 26) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Hope Clin Res & Wellness

Recruiting

Conyers, Georgia, United States, 30094

East West Med Res Inst

Recruiting

Honolulu, Hawaii, United States, 96814

Midwest Inst For Clin Res

Recruiting

Indianapolis, Indiana, United States, 46260

The Alliance for Multispecialty Research LLC AMR

Recruiting

Lexington, Kentucky, United States, 40509

PharmQuest

Recruiting

Greensboro, North Carolina, United States, 27408

KDCILM, LLC & Accellacare US, Inc.

Recruiting

Wilmington, North Carolina, United States, 28401

Coastal Carolina Res Ctr

Recruiting

North Charleston, South Carolina, United States, 29405

Health Res of Hampton Roads

Recruiting

Newport News, Virginia, United States, 23606

National Clin Res Inc.

Recruiting

Richmond, Virginia, United States, 23294

Selma Medical Associates

Recruiting

Winchester, Virginia, United States, 22601-3834

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-04.