What this study is
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.
What's being tested
- Cagrilintide
Intervention · DRUG
Cagrilintide will be administered subcutaneously.
- Placebo (matched to Cagrilintide)
Intervention · DRUG
Placebo matched to Cagrilintide will be administered subcutaneously.
Study details
- Official title
- Tolerability of Cagrilintide in People With Obesity That Discontinued GLP-1-RA Therapies Due to Gastrointestinal Adverse Events: a Double-blinded Randomised Feasibility Study
- Sponsor
- Novo Nordisk A/S
- Conditions
- Obesity · Overweight
- Enrolling
- 114 people
- Starts
- 2026-05-29
- Est. completion
- 2027-11-19
- Design
- Quadruple-blind, randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (13)
13 openDiablo Clinical Research, Inc.
Walnut Creek, California, United States
RecruitingNortheast Research Institute
Fleming Island, Florida, United States
RecruitingJacksonville Ctr For Clin Res
Jacksonville, Florida, United States
RecruitingCenter for Diab,Obes & Metab
Pembroke Pines, Florida, United States
RecruitingEncore Medical Research of Weston
Weston, Florida, United States
RecruitingHope Clin Res & Wellness
Conyers, Georgia, United States
Not yet recruitingMonroe Biomedical Research, LLC
Monroe, North Carolina, United States
RecruitingPHC Accelacare
Statesville, North Carolina, United States
Not yet recruitingAccellacare
Wilmington, North Carolina, United States
RecruitingCoastal Carolina Research Ctr
North Charleston, South Carolina, United States
Not yet recruitingHolston Medical Group_Bristol
Bristol, Tennessee, United States
RecruitingAmarillo Medical Specialists
Amarillo, Texas, United States
RecruitingElligo Clin Res Centre
Austin, Texas, United States
Recruiting
Study team
Sponsor
Novo Nordisk A/S
Study ID NN9833-8420
Study director
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.