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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Florida
Northeast Research Institute
RECRUITING
Fleming Island
Jacksonville Ctr For Clin Res
RECRUITING
Jacksonville
Center for Diab,Obes & Metab
RECRUITING
Pembroke Pines
Encore Medical Research of Weston
RECRUITING
Weston
North Carolina
Monroe Biomedical Research, LLC
RECRUITING
Monroe
Accellacare
RECRUITING
Wilmington
South Carolina
Coastal Carolina Research Ctr
NOT_YET_RECRUITING
North Charleston
Tennessee
Holston Medical Group_Bristol
RECRUITING
Bristol
Texas
Amarillo Medical Specialists
RECRUITING
Amarillo
Elligo Clin Res Centre
RECRUITING
Austin
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2026-05-29
Estimated Completion Date: 2027-11-19
Participants
Target number of participants: 114
Treatments
Experimental: Cagrilintide
Participants will receive Cagrilintide for 26 weeks.
Placebo_comparator: Placebo
Participants will receive placebo matched to Cagrilintide for 26 weeks.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov