Current partner codePEPTIDESDE
NCT07411560·Phase 1·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 1

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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

From registration to results.

  1. First posted

    Feb 17, 2026

  2. Study start

    Feb 9, 2026

  3. Primary completion

    Jan 26, 2027

  4. Study completion

    Jan 26, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Apr 13, 2026

Outcomes

What the study measures.

Primary outcomes

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

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
64 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

1 registered sites.

United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Parexel Research Unit

Harrow, Middlesex, United Kingdom

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cagrilintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.