Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
Novo Nordisk A/S · NCT07607587
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 114
- US sites recruiting
- 10
- Study start
- May 29, 2026
- Record last updated
- October 19, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Cagrilintide; Placebo (matched to Cagrilintide)
Conditions: Obesity; Overweight
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Diablo Clinical Research, Inc.
Walnut Creek, CA 94598
Northeast Research Institute
Fleming Island, FL 32003
Jacksonville Ctr For Clin Res
Jacksonville, FL 32216
Center for Diab,Obes & Metab
Pembroke Pines, FL 33024
Encore Medical Research of Weston
Weston, FL 33331
Monroe Biomedical Research, LLC
Monroe, NC 28112
Accellacare
Wilmington, NC 28401
Holston Medical Group_Bristol
Bristol, TN 37620
Amarillo Medical Specialists
Amarillo, TX 79124
Elligo Clin Res Centre
Austin, TX 78704
Study contacts (from the official record)
- Novo Nordisk · (+1) 866-867-7178 · clinicaltrials@novonordisk.com
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