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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Overweight
• Obese

Interventions

Type	Name	Description
DRUG	Glucose-dependent Insulinotropic Polypeptide (GIP)	Participants will receive GIP subcutaneously.
DRUG	Cagrilintide	Participants will receive Cagrilintide subcutaneously.
DRUG	Placebo GIP	Participants will receive placebo matched to GIP subcutaneously.

Timeline

• Start date: 2026-02-09
• Primary completion: 2027-01-26
• Completion: 2027-01-26
• First posted: 2026-02-17
• Last updated: 2026-04-13

Locations

1 site across 1 country: United Kingdom