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Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)

Active Not RecruitingPhase 2

Sponsor: Zealand Pharma

Conditions: Overweight, Type 2 Diabetes, Obesity

Interventions: Petrelintide, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (48)

Cullman, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Huntington Park, California, United States
North Hollywood, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Waterbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Lake City, Florida, United States
Ocoee, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Canton, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
West Des Moines, Iowa, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Flint, Michigan, United States
Minneapolis, Minnesota, United States
Gulfport, Mississippi, United States
Kansas City, Missouri, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
+ 18 more on CT.gov