Weekly injections of GIP (NNC0480-0389) plus amylin (cagrilintide) to see stomach side effects in adults with overweight or obesity

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 Phase 1, placebo-controlled study compares weekly cagrilintide given with either the experimental GIP agent NNC0480-0389 or a matching placebo to examine safety and stomach-related side effects. Participants will receive each treatment regimen during separate periods so that tolerability on the combination can be compared directly with cagrilintide alone. The trial enrolls adults assigned female at birth with BMI 27.0–39.9 kg/m2 and no significant medical abnormalities, and it lasts about 4.5 months. Outcomes focus on gastrointestinal adverse events and overall safety measures under investigator supervision.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female at birth.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 27.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening.
* Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered eligible with suitable veins for cannulation or repeated venepuncture, as judged by the investigator.
* No clinically significant findings during medical history, physical examination, vital signs, electrocardiogram or clinical laboratory tests at the screening visit, as assessed by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Current participation (i.e., dosing) in any other interventional clinical study within 90 days before screening.
* Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, including incretin-based treatment(s).
* Previous or planned (during the study period) obesity treatment with surgery. However, the following are allowed:

  1. Liposuction and/or abdominoplasty, if performed greater than symbol (\>) 1 year before screening.
  2. Adjustable gastric banding, if the band has been removed \> 1 year before screening.
  3. Intragastric balloon, if the balloon has been removed \> 1 year before screening.
  4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed \> 1 year before screening.

Where it's running

• Parexel Research Unit
  Harrow, Middlesex, United Kingdom 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.