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

January 14, 2026 updated by: Zealand Pharma

A Randomized, Double-Blind, Phase 2 Trial of Once-Weekly Petrelintide Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials - Family Medicine
    • Arizona
      • Chandler, Arizona, United States, 85224
        • AZ Endocrine Institute
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
      • Tucson, Arizona, United States, 85710
        • M3 Wake Research, Tucson Neuroscience Research, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72211-1847
        • Medical Investigation Inc
    • California
      • Huntington Park, California, United States, 90255
        • Velocity Clinical Research
      • North Hollywood, California, United States, 91606
        • Velocity Clinical Research, North Hollywood
      • San Diego, California, United States, 91910
        • Exalt Clinical Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research Inc.
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20009
        • Emerson Clinical Research
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West Florida
      • Jacksonville, Florida, United States, 32204
        • East Coast Institute for Research, LLC
      • Jacksonville, Florida, United States, 32216
        • Solutions Through Advanced Research, Inc
      • Lake City, Florida, United States, 32055
        • M3 Wake Research - Lake City
      • Ocoee, Florida, United States, 34761
        • West Orange Endocrinology P.A
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • M3 Wake Research - Atlanta
      • Canton, Georgia, United States, 30114
        • East Coast Institute for Research - Canton
      • Savannah, Georgia, United States, 31406
        • Privia Medical Group Georgia, LLC
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diabetes & Endocrinology Research Center
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research - New Orleans
    • Michigan
      • Flint, Michigan, United States, 48504
        • AAMRC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Velocity Clinical Research, Gulfport
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • AMR Kansas City
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group, PLLC
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center, Inc.
      • Las Vegas, Nevada, United States, 89106
        • M3 Wake Research - Las Vegas, NV
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Javara Inc
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences, LLC
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Velocity Clinical Research, Cincinnati, Mt. Auburn
      • Columbus, Ohio, United States, 43213
        • Centricity Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Lynn Institute of Norman
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • M3 Wake Research - Charleston
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • M3 Wake Research/ClinSearch, LLC
    • Texas
      • Austin, Texas, United States, 78704
        • Elligo Clinical Research, Inc.
      • Dallas, Texas, United States, 75390-8857
        • The University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77040
        • Juno Research LLC
      • Irving, Texas, United States, 75039
        • Tekton Research, LLC
      • McKinney, Texas, United States, 75069
        • Tekton Research, LLC
      • San Marcos, Texas, United States, 78666
        • Texas Health Care, PLLC
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research
      • Stephenville, Texas, United States, 76401
        • Texas Health Care
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manaasas Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A: Petrelintide Dose 1
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.
Drug: Petrelintide
Petrelintide will be taken by participants once weekly subcutaneously.
Other Names:
  • ZP8396
Placebo Comparator: Treatment B: Petrelintide Placebo Dose 1
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Other: Placebo
Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Experimental: Treatment C: Petrelintide Dose 2
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.
Drug: Petrelintide
Petrelintide will be taken by participants once weekly subcutaneously.
Other Names:
  • ZP8396
Placebo Comparator: Treatment D: Petrelintide Placebo Dose 2
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Other: Placebo
Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Experimental: Treatment E: Petrelintide Dose 3
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
Drug: Petrelintide
Petrelintide will be taken by participants once weekly subcutaneously.
Other Names:
  • ZP8396
Placebo Comparator: Treatment F: Petrelintide Placebo Dose 3
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Other: Placebo
Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage Change in Body Weight
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Achieving ≥5% Body Weight Loss
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≥10% Body Weight Loss
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28
Change in Body Weight (kilogram)
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28
Change in Waist Circumference
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28
Change in Glycated Hemoglobin (HbA1c)
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28
Change in Fasting Glucose
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28
Change in High-Sensitivity C-reactive protein (hsCRP)
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≤6.5% HbA1c
Time Frame: From Baseline (Day 1) to Weeks 28
From Baseline (Day 1) to Weeks 28
Changes in Fasting Lipids
Time Frame: From Baseline (Day 1) to Weeks 28
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
From Baseline (Day 1) to Weeks 38
Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38
Time Frame: From Baseline (Day 1) to Weeks 38
From Baseline (Day 1) to Weeks 38
Number of Participants with Positive Anti-Drug Antibodies (ADAs)
Time Frame: From Baseline (Day 1) to Weeks 38
From Baseline (Day 1) to Weeks 38
Change in Systolic Blood Pressure
Time Frame: From Baseline (Day 1) to Week 38
From Baseline (Day 1) to Week 38
Change in Diastolic Blood Pressure
Time Frame: From Baseline (Day 1) to Week 38
From Baseline (Day 1) to Week 38
Change in Pulse Rate
Time Frame: From Baseline (Day 1) to Week 38
From Baseline (Day 1) to Week 38

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand Pharma

Collaborators

Parexel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Estimated)

August 13, 2026

Study Completion (Estimated)

August 13, 2026

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZP8396-24115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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