Status:
RECRUITING
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet p...
Eligibility Criteria
Inclusion
- Key
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Female or male (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.(a\*)
- Body mass index (BMI) \>= 27.0 kilogram per square meter (kg/m\^2).(a\*)
- Diagnosed with type 2 diabetes \>= 180 days before screening.
- Treatment with either lifestyle intervention(a\*), or:
- Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a\*)
- For up to 30% of participants the following concomitant medication is allowed:
- Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a\*) and/or
- Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day \[U/day\]) stable for at least 90 days before screening.(a\*)
- Key
Exclusion
- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a\*)
- Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(a\*)
- Previous dosing of marketed or non-marketed amylin-based compounds.(a\*) (a\*) - As declared by the participant, reported in the medical records or at the investigator's discretion.
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 28 2027
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT07220759
Start Date
November 5 2025
End Date
July 28 2027
Last Update
December 23 2025
Active Locations (69)
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1
Univ of Alabama_Birmingham
Birmingham, Alabama, United States, 35294
2
Chambliss Clinical Trials, LLC
Montgomery, Alabama, United States, 36106
3
Elite Clinical Network - Tucson
Tucson, Arizona, United States, 85704
4
Scripps Whittier Diabetes Inst
La Jolla, California, United States, 92037