Recruiting
Phase 1

Cagrilintide

Sponsor:

Novo Nordisk A/S

Code:

NCT07607587

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cagrilintide

Placebo (matched to Cagrilintide)

Study Details

Brief summary:

The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.

Conditions

Obesity

Overweight

Study ID

NCT07607587

Start date

May 29, 2026

Status verified date

Jun, 2026

Completion date

Nov 19, 2027

Anticipated

Primary completion date

Nov 19, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Male or female (sex at birth)
  • Age 18 years or above at the time of signing the informed consent
  • History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation
  • Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement
  • Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2)

Key Exclusion Criteria:

  • Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods
  • Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening
  • History of type 1 or type 2 diabetes
  • Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening
  • Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening
  • Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cagrilintide

Participants will receive Cagrilintide for 26 weeks.

placebo comparator: Placebo

Participants will receive placebo matched to Cagrilintide for 26 weeks.

Interventions

Cagrilintide

Cagrilintide will be administered subcutaneously.

Placebo (matched to Cagrilintide)

Placebo matched to Cagrilintide will be administered subcutaneously.

Primary outcome measure

  • Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo [ Time Frame: At week 26 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Northeast Research Institute

Recruiting

Fleming Island, Florida, United States, 32003

Jacksonville Ctr For Clin Res

Recruiting

Jacksonville, Florida, United States, 32216

Center for Diab,Obes & Metab

Recruiting

Pembroke Pines, Florida, United States, 33024

Encore Medical Research of Weston

Recruiting

Weston, Florida, United States, 33331

Monroe Biomedical Research, LLC

Recruiting

Monroe, North Carolina, United States, 28112

Accellacare

Recruiting

Wilmington, North Carolina, United States, 28401

Holston Medical Group_Bristol

Recruiting

Bristol, Tennessee, United States, 37620

Amarillo Medical Specialists

Recruiting

Amarillo, Texas, United States, 79124

Elligo Clin Res Centre

Recruiting

Austin, Texas, United States, 78704

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-06-25.