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Looking for participantsPhase1

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

Sponsor: Novo Nordisk A/S

NCT ID: NCT07411560

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Glucose-dependent Insulinotropic Polypeptide (GIP) (drug), Cagrilintide (drug), Placebo GIP (drug)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 64 Years
Who
Female
Number of participants
100
Started
2026-02-09
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for overweight
  • • Phase1 - 100 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 64 Years
  • • Diagnosed with overweight
  • • Female only

Where?

  • • Harrow - Parexel Research Unit

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

OverweightObese

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 64 Years
  • Who can join: Female only

What the study is looking for

  • ✓Female at birth.
  • ✓Age 18-64 years (both inclusive) at the time of signing the agreement to take part.
  • ✓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.

Who cannot take part

  • ✗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...
  • ✗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...
See the full 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 Is This Study? (1 UK site)

Parexel Research Unit

Harrow HA1 3UJ, United Kingdom

Recruiting

How to Get in Touch

Novo Nordisk

Sponsor contact

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04