Not yet recruitingPhase 1

Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events

Tolerability of Cagrilintide in People With Obesity That Discontinued GLP-1-RA Therapies Due to Gastrointestinal Adverse Events: a Double-blinded Randomised Feasibility Study

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

Estimated enrollment

114

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•Percentage of participants on standard dose or higher dose (yes/no)

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 IDNCT07607587

Org study IDNN9833-8420

Secondary IDU1111-1325-8511World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-05-26actual

Last update posted2026-05-26actual

Study start2026-05-29estimated

Primary completion2027-11-19estimated

Study completion2027-11-19estimated

Assets

Investigational agents

CagriSema / cagrilintide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Key Inclusion Criteria:

•Male or female (sex at birth)

•Age 18 years or above at the time of signing the informed consent

•History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation

•Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement

•Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m^2)

Key Exclusion Criteria:

•Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods

•Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening

•History of type 1 or type 2 diabetes

•Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening

•Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening

•Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening

Endpoints (1)

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.

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo

Time frame:At week 26

threshold achievement, improvement

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.