Current partner codePEPTIDESDE
NCT07607587·Phase 1·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 1

Enrollment

114

Locations

11

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.

Interventions

Treatment arms and agents.

DRUG

Cagrilintide

Cagrilintide will be administered subcutaneously.

DRUG

Placebo (matched to Cagrilintide)

Placebo matched to Cagrilintide will be administered subcutaneously.

Timeline

From registration to results.

  1. First posted

    May 26, 2026

  2. Study start

    May 29, 2026

  3. Primary completion

    Nov 19, 2027

  4. Study completion

    Nov 19, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jun 25, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · At week 26

Measured as percentage of participants.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

11 registered sites.

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

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Northeast Research Institute

Fleming Island, Florida, United States

Jacksonville Ctr For Clin Res

Jacksonville, Florida, United States

Center for Diab,Obes & Metab

Pembroke Pines, Florida, United States

Encore Medical Research of Weston

Weston, Florida, United States

Monroe Biomedical Research, LLC

Monroe, North Carolina, United States

Accellacare

Wilmington, North Carolina, United States

Coastal Carolina Research Ctr

North Charleston, South Carolina, United States

Holston Medical Group_Bristol

Bristol, Tennessee, United States

Amarillo Medical Specialists

Amarillo, Texas, United States

Elligo Clin Res Centre

Austin, Texas, United States

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.