See if cagrilintide is tolerated in people with overweight or obesity who can't continue GLP-1-RA therapy due to GI side effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, randomized, placebo-controlled trial to assess the safety and tolerability of cagrilintide in adults with obesity or overweight who could not continue GLP-1-RA therapy due to GI adverse events. Participants are assigned by chance to receive either cagrilintide or a matching placebo for roughly eight months. The study excludes individuals with diabetes or recent use of glucose-lowering medications and requires BMI ≥ 30 kg/m^2. Primary focus is on tolerability and safety signals, with exploratory observations on weight change. Conducted at third-party clinical research sites in California and Florida under Novo Nordisk A/S sponsorship.

Why it matters

Who can join: the full rules

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

Where it's running

• Diablo Clinical Research, Inc.
  Walnut Creek, California, United States Recruiting
• Northeast Research Institute
  Fleming Island, Florida, United States Recruiting
• Jacksonville Ctr For Clin Res
  Jacksonville, Florida, United States Recruiting
• Center for Diab,Obes & Metab
  Pembroke Pines, Florida, United States Recruiting
• Encore Medical Research of Weston
  Weston, Florida, United States Recruiting
• Monroe Biomedical Research, LLC
  Monroe, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.