Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
Lead Sponsor:
Zealand Pharma
Collaborating Sponsors:
Parexel
Conditions:
Overweight
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.
Eligibility Criteria
Inclusion
- Main
- Male or female participants with body mass index (BMI) ≥27.0 kg/m2.
- Diagnosed with type 2 diabetes ≥180 days prior to the day of screening.
- Treated with metformin with or without sodium-glucose cotransporter 2 inhibitors. Treatment should be stable (same drug\[s\], dose, and dosing frequency) for at least 90 days prior to screening.
- Main
Exclusion
- Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness.
- Receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening.
- A self-reported change in body weight \>5% within 90 days prior to screening, irrespective of medical records.
- Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 90 days prior to screening.
- Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g., sleeve, banding, or similar) that have been removed more than 6 months prior to screening, are allowed.
- Obesity due to endocrine disorders or genetic syndromes.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2026
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT06926842
Start Date
April 22 2025
End Date
August 13 2026
Last Update
December 15 2025
Active Locations (48)
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1
Cullman Clinical Trials - Family Medicine
Cullman, Alabama, United States, 35055
2
AZ Endocrine Institute
Chandler, Arizona, United States, 85224
3
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018
4
M3 Wake Research, Tucson Neuroscience Research, LLC
Tucson, Arizona, United States, 85710