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NCT Number: NCT07411560

A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese

This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone. In one period participants will get two medicines: cagrilintide and NNC0480-0389. In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it. Cagrilintide and NNC0480-0389 is a new medicine being tested to help people with type 2 diabetes and/or overweight or obesity. The trial medicines is not yet approved for use outside of clinical trials. Participants will receive the trial medicines the way the trial doctor has described. The study will last for about 4.5 months.

Recruiting

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Research Unit

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose-dependent Insulinotropic Polypeptide (GIP)

Drug

Participants will receive GIP subcutaneously.

Cagrilintide

Drug

Participants will receive Cagrilintide subcutaneously.

Placebo GIP

Drug

Participants will receive placebo matched to GIP subcutaneously.

Primary outcomes

  1. Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea

    Time frame: From first investigational medicinal products (IMP) administration (visit 2, day 1 or visit 9, day 74) to the end of treatment visit (Visit 2, day 16 or Visit 9, day 89)

    Measured as number of events.

Secondary outcomes

  1. Total number of Adverse Events

    Time frame: First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142)

    Measured as number of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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