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NCT07607587PHASE1Recruiting

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

Novo Nordisk A/S

Start Date

5/29/2026

Completion Date

11/19/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Cagrilintide

DRUG

Placebo (matched to Cagrilintide)

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Conditions

ObesityOverweight

Locations

Diablo Clinical Research, Inc.

Walnut Creek, California 94598

United States

Northeast Research Institute

Fleming Island, Florida 32003

United States

Jacksonville Ctr For Clin Res

Jacksonville, Florida 32216

United States

Center for Diab,Obes & Metab

Pembroke Pines, Florida 33024

United States

Encore Medical Research of Weston

Weston, Florida 33331

United States

Monroe Biomedical Research, LLC

Monroe, North Carolina 28112

United States

Accellacare

Wilmington, North Carolina 28401

United States

Coastal Carolina Research Ctr

North Charleston, South Carolina 29405

United States

Holston Medical Group_Bristol

Bristol, Tennessee 37620

United States

Amarillo Medical Specialists

Amarillo, Texas 79124

United States

Elligo Clin Res Centre

Austin, Texas 78704

United States