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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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