RecruitingPhase 1

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

100

Study population

Obesity / overweight

Eligibility highlights

•Female

Primary endpoint

•Diarrhea (Nausea, Vomiting, Diarrhea)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07411560

Org study IDEX0700-8445

Secondary IDU1111-1324-3573World Health Organization (WHO)

Timeline

Milestones

Study start2026-02-09actual

Study first posted2026-02-17actual

Last update posted2026-04-13actual

Primary completion2027-01-26estimated

Study completion2027-01-26estimated

Assets

Investigational agents

CagriSema / cagrilintide GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexFemale

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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)

Diarrhea

event count, event

componentsNausea, Vomiting, Diarrhea

Secondary/protocol endpoint

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)

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.