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NCT06926842
Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
Conditions: Overweight, Type 2 Diabetes, Obesity
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 221
Sponsor: Zealand Pharma
Location: Cullman Clinical Trials - Family Medicine Cullman Alabama
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
Main Inclusion Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT06926842). StuddyBuddy aggregates publicly available trial information.