Actively Recruiting
Study of Weekly Injections of GIP and Cagrilintide to Assess Gastrointestinal Side Effects in Women With Overweight or Obesity
Led by Novo Nordisk A/S · Updated on 2026-04-13
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of combining two medicines, cagrilintide and NNC0480-0389, in women living with overweight and obesity. This study compares taking both medicines together to taking cagrilintide alone. These medicines are new and are being tested to help people with type 2 diabetes and/or overweight or obesity. The study is a Phase 1 clinical trial sponsored by Novo Nordisk A/S and will last about 4.5 months. Participants will receive weekly injections of two hormones: glucose-dependent insulinotropic polypeptide (GIP) and cagrilintide, or cagrilintide with a placebo version of GIP that looks like the real medicine but has no active ingredient. The study has two treatment periods where doses of GIP and cagrilintide escalate from low to high. Participants are randomly assigned to different sequences of receiving either the combination or the placebo. Both medicines are given as injections under the skin. During the study, participants will be monitored for side effects such as nausea, vomiting, and diarrhea. Researchers will track any treatment-related adverse events from the start of medicine administration through the end of treatment and follow-up visits. Participants will have regular assessments including physical exams, vital signs, laboratory tests, and electrocardiograms. The total study duration for each participant is about 4.5 months with close safety monitoring throughout.
CONDITIONS
Brief 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
Eligibility Criteria
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
You will not qualify if you...
- Known or suspected hypersensitivity to study interventions or related products
- Pregnant, breast-feeding, intending to become pregnant, or of childbearing potential not using highly effective contraception
- Participation in any other interventional clinical study with dosing within 90 days before screening
- Any condition that may jeopardize safety or compliance with protocol
- Treatment with medication for obesity or weight management, including incretin-based treatments, within 90 days before screening
- Previous or planned obesity surgery during study period, except for 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment period lasts approximately 2 weeks, with two treatment periods in total.
Participants receive weekly subcutaneous injections of GIP, Cagrilintide, or placebos in two treatment periods with dose escalation to assess gastrointestinal side effects.
Multiple visits for injections and assessments over approximately 12 weeks
Duration - Up to 6 weeks after treatment ends
Participants are monitored for adverse events and overall safety after completing treatment.
Follow-up visits totaling around 6 weeks
Trial Site Locations
Total: 1 location
1
Parexel Research Unit
Harrow, Middlesex, United Kingdom, HA1 3UJ
Actively Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here