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

Launched by ZEALAND PHARMA · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial, called ZUPREME 2, is looking at a new medication called petrelintide to see if it can help people who are overweight or obese and have type 2 diabetes. The study will compare different doses of petrelintide with a placebo (a treatment that has no active ingredients) to understand how effective and safe it is for managing these conditions. It is currently not recruiting participants, but the trial will include both men and women aged 65 to 74 who have a body mass index (BMI) of 27 or higher and have been diagnosed with type 2 diabetes for at least six months.

To be eligible for this trial, participants must be treating their diabetes with a stable dose of metformin, with or without another type of diabetes medication, for at least 90 days before joining. Some people may not qualify, such as those who have had serious low blood sugar episodes recently or those who have lost a significant amount of weight recently. Participants will have the opportunity to contribute to important research that could improve treatment options for overweight and obese individuals with type 2 diabetes. If you think you might be eligible or are interested in being part of this study, please keep an eye out for when recruitment begins!

Gender

ALL

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 6 months 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.