Actively Recruiting

Phase 1
Age: 18Years - 64Years
FEMALE
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

Led by Novo Nordisk A/S · Updated on 2026-04-13

100

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 64Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female at birth
  • Age 18 to 64 years at the time of informed consent
  • Body mass index (BMI) between 27.0 and 39.9 kg/m² at screening
  • Overweight due to excess adipose tissue as judged by the investigator
  • Suitable veins for cannulation or repeated venepuncture as judged by the investigator
  • No clinically significant findings in medical history, physical exam, vital signs, ECG, or lab tests at screening
Not Eligible

You will not qualify if you...

  • Known or suspected allergy to study drugs or related products
  • Pregnant, breastfeeding, planning pregnancy, or of childbearing potential not using highly effective contraception
  • Currently participating in another interventional clinical study within 90 days before screening
  • Any condition that might risk safety or compliance as judged by the investigator
  • Use of medication for obesity or weight management, including incretin-based treatments, within 90 days before screening
  • Previous or planned obesity surgery during the study period except liposuction, abdominoplasty, adjustable gastric banding removal, intragastric balloon removal, or duodenal-jejunal bypass liner removal if done more than 1 year before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Parexel Research Unit

Harrow, Middlesex, United Kingdom, HA1 3UJ

Actively Recruiting

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Research Team

N

Novo Nordisk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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