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

NCT ID: NCT06926842

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-22

Study Completion Date

2026-08-13

Brief Summary

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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

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Conditions

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Overweight Type 2 Diabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A: Petrelintide Dose 1

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.

Group Type EXPERIMENTAL

Petrelintide

Intervention Type DRUG

Petrelintide will be taken by participants once weekly subcutaneously.

Treatment B: Petrelintide Placebo Dose 1

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Treatment C: Petrelintide Dose 2

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.

Group Type EXPERIMENTAL

Petrelintide

Intervention Type DRUG

Petrelintide will be taken by participants once weekly subcutaneously.

Treatment D: Petrelintide Placebo Dose 2

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Treatment E: Petrelintide Dose 3

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.

Group Type EXPERIMENTAL

Petrelintide

Intervention Type DRUG

Petrelintide will be taken by participants once weekly subcutaneously.

Treatment F: Petrelintide Placebo Dose 3

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Petrelintide

Petrelintide will be taken by participants once weekly subcutaneously.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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ZP8396

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

Zealand Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cullman Clinical Trials - Family Medicine

Cullman, Alabama, United States

Site Status

AZ Endocrine Institute

Chandler, Arizona, United States

Site Status

Elite Clinical Studies, LLC

Phoenix, Arizona, United States

Site Status

M3 Wake Research, Tucson Neuroscience Research, LLC

Tucson, Arizona, United States

Site Status

Medical Investigation Inc

Little Rock, Arkansas, United States

Site Status

Velocity Clinical Research

Huntington Park, California, United States

Site Status

Velocity Clinical Research, North Hollywood

North Hollywood, California, United States

Site Status

Exalt Clinical Research

San Diego, California, United States

Site Status

Diablo Clinical Research Inc.

Walnut Creek, California, United States

Site Status

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status

Emerson Clinical Research

Washington D.C., District of Columbia, United States

Site Status

Innovative Research of West Florida

Clearwater, Florida, United States

Site Status

East Coast Institute for Research, LLC

Jacksonville, Florida, United States

Site Status

Solutions Through Advanced Research, Inc

Jacksonville, Florida, United States

Site Status

M3 Wake Research - Lake City

Lake City, Florida, United States

Site Status

West Orange Endocrinology P.A

Ocoee, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

M3 Wake Research - Atlanta

Atlanta, Georgia, United States

Site Status

East Coast Institute for Research - Canton

Canton, Georgia, United States

Site Status

Privia Medical Group Georgia, LLC

Savannah, Georgia, United States

Site Status

Great Lakes Clinical Trials

Chicago, Illinois, United States

Site Status

Iowa Diabetes & Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

DelRicht Research - New Orleans

New Orleans, Louisiana, United States

Site Status

AAMRC

Flint, Michigan, United States

Site Status

International Diabetes Center

Minneapolis, Minnesota, United States

Site Status

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, United States

Site Status

AMR Kansas City

Kansas City, Missouri, United States

Site Status

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Site Status

M3 Wake Research - Las Vegas, NV

Las Vegas, Nevada, United States

Site Status

Palm Research Center, Inc.

Las Vegas, Nevada, United States

Site Status

Javara Inc

Charlotte, North Carolina, United States

Site Status

PharmQuest Life Sciences, LLC

Greensboro, North Carolina, United States

Site Status

M3 Wake Research

Raleigh, North Carolina, United States

Site Status

Velocity Clinical Research, Cincinnati, Mt. Auburn

Cincinnati, Ohio, United States

Site Status

Centricity Research

Columbus, Ohio, United States

Site Status

Lynn Institute of Norman

Norman, Oklahoma, United States

Site Status

M3 Wake Research - Charleston

Charleston, South Carolina, United States

Site Status

M3 Wake Research/ClinSearch, LLC

Chattanooga, Tennessee, United States

Site Status

Elligo Clinical Research, Inc.

Austin, Texas, United States

Site Status

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Juno Research LLC

Houston, Texas, United States

Site Status

Tekton Research, LLC

Irving, Texas, United States

Site Status

Tekton Research, LLC

McKinney, Texas, United States

Site Status

Texas Health Care, PLLC

San Marcos, Texas, United States

Site Status

Consano Clinical Research

Shavano Park, Texas, United States

Site Status

Texas Health Care

Stephenville, Texas, United States

Site Status

Manaasas Clinical Research Center

Manassas, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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ZP8396-24115

Identifier Type: -

Identifier Source: org_study_id

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