Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
- Conditions
- OverweightType 2 DiabetesObesity
- Interventions
- Other: Placebo
- Registration Number
- NCT06926842
- Lead Sponsor
- Zealand Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment A: Petrelintide Dose 1 Petrelintide Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1. Treatment B: Petrelintide Placebo Dose 1 Placebo Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. Treatment F: Petrelintide Placebo Dose 3 Placebo Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. Treatment C: Petrelintide Dose 2 Petrelintide Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2. Treatment D: Petrelintide Placebo Dose 2 Placebo Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. Treatment E: Petrelintide Dose 3 Petrelintide Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
- Primary Outcome Measures
Name Time Method Percentage Change in Body Weight From Baseline (Day 1) to Weeks 28
- Secondary Outcome Measures
Name Time Method 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 Change in Fasting Glucose From Baseline (Day 1) to Weeks 28 Change in High-Sensitivity C-reactive protein (hsCRP) From Baseline (Day 1) to Weeks 28 Number of Participants Achieving <7% HbA1c From Baseline (Day 1) to Weeks 28 Number of Participants Achieving ≤6.5% HbA1c From Baseline (Day 1) to Weeks 28 Changes in Fasting Lipids From Baseline (Day 1) to Weeks 28 Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) From Baseline (Day 1) to Weeks 38 Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38 From Baseline (Day 1) to Weeks 38 Number of Participants with Positive Anti-Drug Antibodies (ADAs) From Baseline (Day 1) to Weeks 38 Change in Systolic Blood Pressure From Baseline (Day 1) to Week 38 Change in Diastolic Blood Pressure From Baseline (Day 1) to Week 38 Change in Pulse Rate From Baseline (Day 1) to Week 38
Related Research Topics
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Trial Locations
- Locations (25)
Cullman Clinical Trials - Family Medicine
🇺🇸Cullman, Alabama, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Medical Investigation Inc
🇺🇸Little Rock, Arkansas, United States
AMCR Institute, Inc.
🇺🇸Escondido, California, United States
Velocity Clinical Research
🇺🇸Huntington Park, California, United States
Diablo Clinical Research Inc.
🇺🇸Walnut Creek, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, 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
West Orange Endocrinology P.A
🇺🇸Ocoee, Florida, United States
East Coast Institute for Research - Canton
🇺🇸Canton, Georgia, United States
Iowa Diabetes & Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
DelRicht Research - New Orleans
🇺🇸New Orleans, Louisiana, United States
AAMRC
🇺🇸Flint, Michigan, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Mercury Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
Palm Research Center, Inc.
🇺🇸Las Vegas, Nevada, United States
PharmQuest Life Sciences, LLC
🇺🇸Greensboro, North Carolina, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Elligo Clinical Research, Inc.
🇺🇸Austin, Texas, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Juno Research LLC
🇺🇸Houston, Texas, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
Manaasas Clinical Research Center
🇺🇸Manassas, Virginia, United States