Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Diablo Clinical Research, Inc., Walnut Creek, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously.

Placebo (matched to Cagrilintide)

Drug

Placebo matched to Cagrilintide will be administered subcutaneously.

Primary outcomes

Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo

Time frame: At week 26

Measured as percentage of participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Tolerability of Cagrilintide in People With Obesity That Discontinued GLP-1-RA Therapies Due to Gastrointestinal Adverse Events: a Double-blinded Randomised Feasibility Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 26, 2026
Registry last updated: Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting