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

Single-centre Study Investigating the Role of Long-acting Subcutaneous Glucose-dependent Insulinotropic Polypeptide Receptor Agonist (GIP RA) in Combination With Long-acting Subcutaneous Amylin Receptor Agonist on Gastrointestinal Tolerability in Participants With Overweight or Obesity

This trial tests whether adding a GIP injection (NNC0480-0389) to weekly cagrilintide changes stomach-related side effects in adults with overweight or obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 64 Years
• Sex: Female
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Harrow, Middlesex)
• Trial ID: NCT07411560 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults assigned female at birth aged 18–64 years with a BMI of 27.0–39.9 kg/m2, suitable veins for blood draws, and no clinically significant medical issues are the intended participants.

Not a fit: People who are male, younger than 18 or older than 64, pregnant or breastfeeding, have a BMI outside 27.0–39.9 kg/m2, have significant medical problems, or are currently in another interventional study would not qualify and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could improve understanding of tolerability and help develop better medication options for managing overweight or obesity.

How similar studies have performed: Related combinations involving amylin analogs or GIP/GLP-1 agents have shown promising weight-loss and tolerability signals, but combining a GIP agent specifically with an amylin analog is a relatively novel approach with limited prior data.

Eligibility criteria

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 this trial is running

Harrow, Middlesex

• Parexel Research Unit — Harrow, Middlesex, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Overweight; Obese