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OverweightPhase 2NCT06926842

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

A Phase 2 study testing Petrelintide in people with Overweight and Type 2 Diabetes, run by Zealand Pharma at 48 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Type 2 Diabetes, Obesity
What is being tested?
Petrelintide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
48 sitesUnited States
Study dates
22 Apr 2025to 13 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • M3 Wake Research - Atlanta

    Atlanta, Georgia, 30328

  • Elligo Clinical Research, Inc.

    Austin, Texas, 78704

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • East Coast Institute for Research - Canton

    Canton, Georgia, 30114

  • AZ Endocrine Institute

    Chandler, Arizona, 85224

  • M3 Wake Research - Charleston

    Charleston, South Carolina, 29414

  • Javara Inc

    Charlotte, North Carolina, 28210

  • M3 Wake Research/ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Velocity Clinical Research, Cincinnati, Mt. Auburn

    Cincinnati, Ohio, 45219

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Centricity Research

    Columbus, Ohio, 43213

  • Cullman Clinical Trials - Family Medicine

    Cullman, Alabama, 35055

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8857

  • AAMRC

    Flint, Michigan, 48504

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina, 27408

  • Velocity Clinical Research, Gulfport

    Gulfport, Mississippi, 39503

  • Juno Research LLC

    Houston, Texas, 77040

  • Velocity Clinical Research

    Huntington Park, California, 90255

  • Tekton Research, LLC

    Irving, Texas, 75039

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32204

  • Solutions Through Advanced Research, Inc

    Jacksonville, Florida, 32216

  • AMR Kansas City

    Kansas City, Missouri, 64114

  • M3 Wake Research - Lake City

    Lake City, Florida, 32055

  • M3 Wake Research - Las Vegas, NV

    Las Vegas, Nevada, 89106

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89148

  • Medical Investigation Inc

    Little Rock, Arkansas, 72211-1847

  • Manaasas Clinical Research Center

    Manassas, Virginia, 20110

  • Tekton Research, LLC

    McKinney, Texas, 75069

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • DelRicht Research - New Orleans

    New Orleans, Louisiana, 70115

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606

  • West Orange Endocrinology P.A

    Ocoee, Florida, 34761

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • M3 Wake Research

    Raleigh, North Carolina, 27612

  • Exalt Clinical Research

    San Diego, California, 91910

  • Texas Health Care, PLLC

    San Marcos, Texas, 78666

  • Privia Medical Group Georgia, LLC

    Savannah, Georgia, 31406

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • Texas Health Care

    Stephenville, Texas, 76401

  • M3 Wake Research, Tucson Neuroscience Research, LLC

    Tucson, Arizona, 85710

  • Diablo Clinical Research Inc.

    Walnut Creek, California, 94598

  • Emerson Clinical Research

    Washington D.C., District of Columbia, 20009

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Iowa Diabetes & Endocrinology Research Center

    West Des Moines, Iowa, 50266

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67226

Other trials in United States

About this study

Official title: 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.

Being tested
Petrelintide, Placebo
Keywords
Long-acting amylin analogues, Weight management
Medical subject headings
Overweight, Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PetrelintideDrug

    Also called ZP8396

    Petrelintide will be taken by participants once weekly subcutaneously.

  • PlaceboOther

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

Study groups in NCT06926842
Study groupRoleWhat they receive
Treatment A: Petrelintide Dose 1ExperimentalRandomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.
Receives: Drug: Petrelintide
Treatment B: Petrelintide Placebo Dose 1Placebo comparatorRandomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Receives: Other: Placebo
Treatment C: Petrelintide Dose 2ExperimentalRandomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.
Receives: Drug: Petrelintide
Treatment D: Petrelintide Placebo Dose 2Placebo comparatorRandomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Receives: Other: Placebo
Treatment E: Petrelintide Dose 3ExperimentalRandomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
Receives: Drug: Petrelintide
Treatment F: Petrelintide Placebo Dose 3Placebo comparatorRandomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change in Body Weight

    Measured: From Baseline (Day 1) to Weeks 28

Secondary outcomes (15)

  1. Number of Participants Achieving ≥5% Body Weight Loss

    Measured: From Baseline (Day 1) to Weeks 28

  2. Number of Participants Achieving ≥10% Body Weight Loss

    Measured: From Baseline (Day 1) to Weeks 28

  3. Change in Body Weight (kilogram)

    Measured: From Baseline (Day 1) to Weeks 28

  4. Change in Waist Circumference

    Measured: From Baseline (Day 1) to Weeks 28

  5. Change in Glycated Hemoglobin (HbA1c)

    Measured: From Baseline (Day 1) to Weeks 28

  6. Change in Fasting Glucose

    Measured: From Baseline (Day 1) to Weeks 28

  7. Change in High-Sensitivity C-reactive protein (hsCRP)

    Measured: From Baseline (Day 1) to Weeks 28

  8. Number of Participants Achieving ≤6.5% HbA1c

    Measured: From Baseline (Day 1) to Weeks 28

  9. Changes in Fasting Lipids

    Measured: From Baseline (Day 1) to Weeks 28

  10. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    Measured: From Baseline (Day 1) to Weeks 38

  11. Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38

    Measured: From Baseline (Day 1) to Weeks 38

  12. Number of Participants with Positive Anti-Drug Antibodies (ADAs)

    Measured: From Baseline (Day 1) to Weeks 38

  13. Change in Systolic Blood Pressure

    Measured: From Baseline (Day 1) to Week 38

  14. Change in Diastolic Blood Pressure

    Measured: From Baseline (Day 1) to Week 38

  15. Change in Pulse Rate

    Measured: From Baseline (Day 1) to Week 38

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2025
  2. Study start22 Apr 2025
  3. Primary completion13 Aug 2026
  4. Study completion13 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926842
Sponsor's protocol ID
ZP8396-24115
Status last verified
Sep 2026
First submitted
11 Apr 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Petrelintide in people with Overweight and Type 2 Diabetes, run by Zealand Pharma at 48 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Body Weight (time frame: From Baseline (Day 1) to Weeks 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06926842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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