ACTIVE_NOT_RECRUITING

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

Talk to us

Conditions

OverweightType 2 DiabetesObesityLong-acting amylin analoguesWeight management

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-22
Study Completion:2026-08-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06926842

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female participants with body mass index (BMI) ≥27.0 kg/m2.
  2. * Diagnosed with type 2 diabetes ≥180 days prior to the day of screening.
  3. * 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.
  1. * Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness.
  2. * Receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening.
  3. * A self-reported change in body weight \>5% within 90 days prior to screening, irrespective of medical records.
  4. * 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.
  5. * 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.
  6. * Obesity due to endocrine disorders or genetic syndromes.

Contacts and Locations

Study Locations (Sites)

Cullman Clinical Trials - Family Medicine
Cullman, Alabama, 35055
United States
AZ Endocrine Institute
Chandler, Arizona, 85224
United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
United States
M3 Wake Research, Tucson Neuroscience Research, LLC
Tucson, Arizona, 85710
United States
Medical Investigation Inc
Little Rock, Arkansas, 72211-1847
United States
Velocity Clinical Research
Huntington Park, California, 90255
United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606
United States
Exalt Clinical Research
San Diego, California, 91910
United States
Diablo Clinical Research Inc.
Walnut Creek, California, 94598
United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
United States
Emerson Clinical Research
Washington D.C., District of Columbia, 20009
United States
Innovative Research of West Florida
Clearwater, Florida, 33756
United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204
United States
Solutions Through Advanced Research, Inc
Jacksonville, Florida, 32216
United States
M3 Wake Research - Lake City
Lake City, Florida, 32055
United States
West Orange Endocrinology P.A
Ocoee, Florida, 34761
United States
Palm Beach Research Center
West Palm Beach, Florida, 33409
United States
M3 Wake Research - Atlanta
Atlanta, Georgia, 30328
United States
East Coast Institute for Research - Canton
Canton, Georgia, 30114
United States
Privia Medical Group Georgia, LLC
Savannah, Georgia, 31406
United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640
United States
Iowa Diabetes & Endocrinology Research Center
West Des Moines, Iowa, 50266
United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207
United States
DelRicht Research - New Orleans
New Orleans, Louisiana, 70115
United States
AAMRC
Flint, Michigan, 48504
United States
International Diabetes Center
Minneapolis, Minnesota, 55416
United States
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, 39503
United States
AMR Kansas City
Kansas City, Missouri, 64114
United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
United States
M3 Wake Research - Las Vegas, NV
Las Vegas, Nevada, 89106
United States
Palm Research Center, Inc.
Las Vegas, Nevada, 89148
United States
Javara Inc
Charlotte, North Carolina, 28210
United States
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408
United States
M3 Wake Research
Raleigh, North Carolina, 27612
United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, 45219
United States
Centricity Research
Columbus, Ohio, 43213
United States
Lynn Institute of Norman
Norman, Oklahoma, 73072
United States
M3 Wake Research - Charleston
Charleston, South Carolina, 29414
United States
M3 Wake Research/ClinSearch, LLC
Chattanooga, Tennessee, 37421
United States
Elligo Clinical Research, Inc.
Austin, Texas, 78704
United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8857
United States
Juno Research LLC
Houston, Texas, 77040
United States
Tekton Research, LLC
Irving, Texas, 75039
United States
Tekton Research, LLC
McKinney, Texas, 75069
United States
Texas Health Care, PLLC
San Marcos, Texas, 78666
United States
Consano Clinical Research
Shavano Park, Texas, 78231
United States
Texas Health Care
Stephenville, Texas, 76401
United States
Manaasas Clinical Research Center
Manassas, Virginia, 20110
United States

Collaborators and Investigators

Sponsor: Zealand Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-22
Study Completion Date2026-08-13

Study Record Updates

Study Start Date2025-04-22
Study Completion Date2026-08-13

Terms related to this study

Keywords Provided by Researchers

  • Long-acting amylin analogues
  • Weight management

Additional Relevant MeSH Terms

  • Overweight
  • Type 2 Diabetes
  • Obesity