Clinical trial

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

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT06926842

Active, not recruitingPhase 2Interventional

What this study is about

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 promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Type 2 Diabetes, Obesity

Full registry criteria

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.

Treatments and study arms

Petrelintide

Drug

Petrelintide will be taken by participants once weekly subcutaneously.

Placebo

Other

Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.

Primary outcomes

Percentage Change in Body WeightFrom Baseline (Day 1) to Weeks 28

Study locations

48 locations were listed when this page was built. The first 40 are shown.

M3 Wake Research - Atlanta🇺🇸 Atlanta, Georgia, United States
Elligo Clinical Research, Inc.🇺🇸 Austin, Texas, United States
Mercury Street Medical Group, PLLC🇺🇸 Butte, Montana, United States
East Coast Institute for Research - Canton🇺🇸 Canton, Georgia, United States
AZ Endocrine Institute🇺🇸 Chandler, Arizona, United States
M3 Wake Research - Charleston🇺🇸 Charleston, South Carolina, United States
Javara Inc🇺🇸 Charlotte, North Carolina, United States
M3 Wake Research/ClinSearch, LLC🇺🇸 Chattanooga, Tennessee, United States
Great Lakes Clinical Trials🇺🇸 Chicago, Illinois, United States
Velocity Clinical Research, Cincinnati, Mt. Auburn🇺🇸 Cincinnati, Ohio, United States
Innovative Research of West Florida🇺🇸 Clearwater, Florida, United States
Centricity Research🇺🇸 Columbus, Ohio, United States
Cullman Clinical Trials - Family Medicine🇺🇸 Cullman, Alabama, United States
The University of Texas Southwestern Medical Center🇺🇸 Dallas, Texas, United States
AAMRC🇺🇸 Flint, Michigan, United States
PharmQuest Life Sciences, LLC🇺🇸 Greensboro, North Carolina, United States
Velocity Clinical Research, Gulfport🇺🇸 Gulfport, Mississippi, United States
Juno Research LLC🇺🇸 Houston, Texas, United States
Velocity Clinical Research🇺🇸 Huntington Park, California, United States
Tekton Research, LLC🇺🇸 Irving, Texas, United States
East Coast Institute for Research, LLC🇺🇸 Jacksonville, Florida, United States
Solutions Through Advanced Research, Inc🇺🇸 Jacksonville, Florida, United States
AMR Kansas City🇺🇸 Kansas City, Missouri, United States
M3 Wake Research - Lake City🇺🇸 Lake City, Florida, United States
M3 Wake Research - Las Vegas, NV🇺🇸 Las Vegas, Nevada, United States
Palm Research Center, Inc.🇺🇸 Las Vegas, Nevada, United States
Medical Investigation Inc🇺🇸 Little Rock, Arkansas, United States
Manaasas Clinical Research Center🇺🇸 Manassas, Virginia, United States
Tekton Research, LLC🇺🇸 McKinney, Texas, United States
International Diabetes Center🇺🇸 Minneapolis, Minnesota, United States
DelRicht Research - New Orleans🇺🇸 New Orleans, Louisiana, United States
Lynn Institute of Norman🇺🇸 Norman, Oklahoma, United States
Velocity Clinical Research, North Hollywood🇺🇸 North Hollywood, California, United States
West Orange Endocrinology P.A🇺🇸 Ocoee, Florida, United States
Elite Clinical Studies, LLC🇺🇸 Phoenix, Arizona, United States
M3 Wake Research🇺🇸 Raleigh, North Carolina, United States
Exalt Clinical Research🇺🇸 San Diego, California, United States
Texas Health Care, PLLC🇺🇸 San Marcos, Texas, United States
Privia Medical Group Georgia, LLC🇺🇸 Savannah, Georgia, United States
Consano Clinical Research🇺🇸 Shavano Park, Texas, United States