NCT07607587RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 19 May 2026
- Start date
- 29 May 2026
- Primary completion date
- 19 Nov 2027
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT07607587
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 114
- From 29 May 2026 to the primary completion date, 19 Nov 2027
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening
- Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening
Other illness
- History of type 1 or type 2 diabetes
Lab values
- 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
Other
- Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amarillo Medical Specialists Coordinator of this site? Confirm its status | Amarillo | United States | Recruiting |
| Elligo Clin Res Centre Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Holston Medical Group_Bristol Coordinator of this site? Confirm its status | Bristol | United States | Recruiting |
| Hope Clin Res & Wellness Coordinator of this site? Confirm its status | Conyers | United States | Not yet recruiting |
| Northeast Research Institute Coordinator of this site? Confirm its status | Fleming Island | United States | Recruiting |
| Jacksonville Ctr for Clin Res Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Monroe Biomedical Research, LLC Coordinator of this site? Confirm its status | Monroe | United States | Recruiting |
| Coastal Carolina Research Ctr Coordinator of this site? Confirm its status | North Charleston | United States | Not yet recruiting |
| Center for Diab,Obes & Metab Coordinator of this site? Confirm its status | Pembroke Pines | United States | Recruiting |
| PHC Accelacare Coordinator of this site? Confirm its status | Statesville | United States | Not yet recruiting |
| Diablo Clinical Research, Inc. Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| Encore Medical Research of Weston Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
| Accellacare Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.