Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
Recruiting · NCT07607587 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
CagrilintidePlacebo (matched to Cagrilintide)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
11 locations listed across 6 US states.
- 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