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

Description

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.

Conditions

Overweight, Type 2 Diabetes, Obesity

Study Overview

Study Details

Study overview

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.

A Randomized, Double-Blind, Phase 2 Trial of Once-Weekly Petrelintide Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes

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

Condition
Overweight
Intervention / Treatment

-

Contacts and Locations

Cullman

Cullman Clinical Trials - Family Medicine, Cullman, Alabama, United States, 35055

Phoenix

Elite Clinical Studies, LLC, Phoenix, Arizona, United States, 85018

Little Rock

Medical Investigation Inc, Little Rock, Arkansas, United States, 72211-1847

Escondido

AMCR Institute, Inc., Escondido, California, United States, 92025

Huntington Park

Velocity Clinical Research, Huntington Park, California, United States, 90255

Walnut Creek

Diablo Clinical Research Inc., Walnut Creek, California, United States, 94598

Waterbury

Chase Medical Research, LLC, Waterbury, Connecticut, United States, 06708

Clearwater

Innovative Research of West Florida, Clearwater, Florida, United States, 33756

Jacksonville

East Coast Institute for Research, LLC, Jacksonville, Florida, United States, 32204

Jacksonville

Solutions Through Advanced Research, Inc, Jacksonville, Florida, United States, 32216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zealand Pharma,

Study Record Dates

2026-06-04