DRUG
Petrelintide
Petrelintide will be taken by participants once weekly subcutaneously.
Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
Status
Active, not recruiting
Phase
Phase 2
Enrollment
221
Locations
48
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
OTHER
Placebo
Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Timeline
From registration to results.
First posted
Apr 15, 2025
Study start
Apr 22, 2025
Primary completion
Aug 13, 2026
Study completion
Aug 13, 2026
Results posted
Not reported
Registry updated
Jan 15, 2026
Outcomes
What the study measures.
Primary outcomes
Percentage Change in Body Weight
Time frame · From Baseline (Day 1) to Weeks 28
Secondary outcomes
Number of Participants Achieving ≥5% Body Weight Loss
Time frame · From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≥10% Body Weight Loss
Time frame · From Baseline (Day 1) to Weeks 28
Change in Body Weight (kilogram)
Time frame · From Baseline (Day 1) to Weeks 28
Change in Waist Circumference
Time frame · From Baseline (Day 1) to Weeks 28
Change in Glycated Hemoglobin (HbA1c)
Time frame · From Baseline (Day 1) to Weeks 28
Change in Fasting Glucose
Time frame · From Baseline (Day 1) to Weeks 28
Change in High-Sensitivity C-reactive protein (hsCRP)
Time frame · From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≤6.5% HbA1c
Time frame · From Baseline (Day 1) to Weeks 28
Changes in Fasting Lipids
Time frame · From Baseline (Day 1) to Weeks 28
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame · From Baseline (Day 1) to Weeks 38
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
48 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Cullman Clinical Trials - Family Medicine
Cullman, Alabama, United States
AZ Endocrine Institute
Chandler, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
M3 Wake Research, Tucson Neuroscience Research, LLC
Tucson, Arizona, United States
Medical Investigation Inc
Little Rock, Arkansas, United States
Velocity Clinical Research
Huntington Park, California, United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, United States
Exalt Clinical Research
San Diego, California, United States
Diablo Clinical Research Inc.
Walnut Creek, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Emerson Clinical Research
Washington D.C., District of Columbia, United States
Innovative Research of West Florida
Clearwater, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Solutions Through Advanced Research, Inc
Jacksonville, Florida, United States
M3 Wake Research - Lake City
Lake City, Florida, United States
West Orange Endocrinology P.A
Ocoee, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
M3 Wake Research - Atlanta
Atlanta, Georgia, United States
East Coast Institute for Research - Canton
Canton, Georgia, United States
Privia Medical Group Georgia, LLC
Savannah, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Iowa Diabetes & Endocrinology Research Center
West Des Moines, Iowa, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
DelRicht Research - New Orleans
New Orleans, Louisiana, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Petrelintide.
NCT IDStudyPhase / statusEnrollmentUpdated
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2026-04
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2026-03
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2026-01
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.