Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
A Randomized, Double-Blind, Phase 2 Trial of Once-Weekly Petrelintide Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes
1 other identifier
interventional
221
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2025
Shorter than P25 for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2025
CompletedStudy Start
First participant enrolled
April 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 13, 2026
January 15, 2026
January 1, 2026
1.3 years
April 11, 2025
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in Body Weight
From Baseline (Day 1) to Weeks 28
Secondary Outcomes (15)
Number of Participants Achieving ≥5% Body Weight Loss
From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≥10% Body Weight Loss
From Baseline (Day 1) to Weeks 28
Change in Body Weight (kilogram)
From Baseline (Day 1) to Weeks 28
Change in Waist Circumference
From Baseline (Day 1) to Weeks 28
Change in Glycated Hemoglobin (HbA1c)
From Baseline (Day 1) to Weeks 28
- +10 more secondary outcomes
Study Arms (6)
Treatment A: Petrelintide Dose 1
EXPERIMENTALRandomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.
Treatment B: Petrelintide Placebo Dose 1
PLACEBO COMPARATORRandomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Treatment C: Petrelintide Dose 2
EXPERIMENTALRandomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.
Treatment D: Petrelintide Placebo Dose 2
PLACEBO COMPARATORRandomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Treatment E: Petrelintide Dose 3
EXPERIMENTALRandomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
Treatment F: Petrelintide Placebo Dose 3
PLACEBO COMPARATORRandomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Interventions
Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Petrelintide will be taken by participants once weekly subcutaneously.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zealand Pharmalead
- Parexelcollaborator
Study Sites (48)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 15, 2025
Study Start
April 22, 2025
Primary Completion (Estimated)
August 13, 2026
Study Completion (Estimated)
August 13, 2026
Last Updated
January 15, 2026
Record last verified: 2026-01