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Trial · Interventional

CompletedPhase 2Registry data

Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities

Short name ZUPREME

NCTNCT06662539 (opens ClinicalTrials.gov in a new tab)Other idZP8396-23094Other id2024-512549-18

Overview

Status
Completed
Phase
Phase 2
Enrollment
493 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Double masking
Countries
3 countries

United States, Poland, Romania

Start
9 Dec 2024
Primary completion
30 Sept 2025
Completion
7 Mar 2026
First posted
29 Oct 2024
Last update posted
23 Mar 2026
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 2

    ZUPREME

    NCT06662539

    9 Dec 2024 to 7 Mar 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability.

Interventions

  • PetrelintideDrug
  • PlaceboDrug

Arms6

  • Experimental

    Petrelintide Dose 1

    Participants will self-inject petrelintide dose 1 subcutaneously once a week.

  • Experimental

    Petrelintide Dose 2

    Participants will self-inject petrelintide dose 2 subcutaneously once a week.

  • Experimental

    Petrelintide Dose 3

    Participants will self-inject petrelintide dose 3 subcutaneously once a week.

  • Experimental

    Petrelintide Dose 4

    Participants will self-inject petrelintide dose 4 subcutaneously once a week.

  • Experimental

    Petrelintide Dose 5

    Participants will self-inject petrelintide dose 5 subcutaneously once a week.

  • Placebo comparator

    Placebo

    Participants will self-inject matching placebo to petrelintide subcutaneously once a week.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent change from baseline in body weight to Week 28

    Time frame · From Baseline (Day 1) to Week 28

    Registry description

    To compare the dose-response of increasing doses of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity after 28 weeks of exposure.

Secondary outcomes(11)
  1. Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42

    Time frame · From Baseline (Day 1) to Weeks 28 and 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  2. Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42

    Time frame · From Baseline (Day 1) to Weeks 28 and 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  3. Change from baseline in body weight to Weeks 28 and 42

    Time frame · From Baseline (Day 1) to Weeks 28 and 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  4. Change from baseline in waist circumference to Weeks 28 and 42

    Time frame · From Baseline (Day 1) to Weeks 28 and 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on waist circumference, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  5. Percent change from baseline in body weight to Week 42

    Time frame · From Baseline (Day 1) to Week 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  6. Change from baseline in hemoglobin A1c (HbA1c) to Week 42

    Time frame · From Baseline (Day 1) to Week 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on HbA1c, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  7. Change from baseline in fasting glucose to Week 42

    Time frame · From Baseline (Day 1) to Week 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on fasting glucose, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  8. Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42

    Time frame · From Baseline (Day 1) to Week 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on hsCRP, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  9. Change from baseline in fasting lipids to Week 42

    Time frame · From Baseline (Day 1) to Week 42

    Registry description

    To compare the efficacy of petrelintide versus placebo on fasting lipids, when added as an adjunct to a reduced-calorie diet and increased physical activity.

  10. Number of treatment emergent adverse events (TEAEs)

    Time frame · From Baseline (Day 1) to Week 51

    Registry description

    To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.

  11. Occurrences of anti-drug antibodies (ADAs) to petrelintide

    Time frame · From Baseline (Day 1) to Week 51

    Registry description

    To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

11 results

Petrelintide, a human amylin analogue for the treatment of obesity (ZUPREME 1): a randomised, double-blind, placebo-controlled, phase 2 trial.

Garvey et al. 2026The lancet. Diabetes & endocrinology

PMID 42810355DOI 10.1016/s2213-8587(26)00213-5PUB-42810355

Full text at the publisher11 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female participants having body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of at least one of the following comorbidities: hypertension or dyslipidemia (treated or untreated). * A female participant is eligible to participate if she is: * A woman of nonchildbearing potential. OR * A woman of childbearing potential (WOCBP) who is not pregnant, does not intend to be pregnant, not lactating and is willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial and for 10 weeks after the last injection of the investigational medicinal product (IMP). * Ability to comply with the protocol requirements including self-administration of IMP with vial and syringe. Exclusion Criteria: * Glycated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%), as measured at screening. * History of type 1 or type 2 diabetes mellitus. * Treatment with glucose lowering agent(s) within 90 days prior to screening. * A self-reported change in body weight \>5% within 90 days prior to screening. * Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months 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. * Uncontrolled thyroid disease defined as thyroid stimulating hormone \>4.20 mIU/L or \<0.27 mIU/L as measured by the central laboratory at screening. * Lifetime history of a suicidal attempt. * History of major depressive disorder or other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder). * Estimated glomerular filtration rate value \<60.0 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation17, measured at screening. * Impaired liver function, defined as alanine aminotransferase and/or aspartate aminotransferase ≥2.0 times or bilirubin \>1.5 times upper normal limit, measured at screening. * Presence or history of acute or chronic pancreatitis. * Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronic treatment that affects gastrointestinal (GI) motility. * Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation. * Presence or history of clinically significant arrhythmias or clinically significant conduction disorders. * Known or suspected hypersensitivity to amylin analogs or related products. * History of malignant neoplasms (except for basal or squamous cell skin cancer) within 5 years prior to screening. * Known or suspected abuse of alcohol or recreational drugs. * Participant previously treated with petrelintide or any other amylin analog.

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