ZUPREME

CompletedPhase 2

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

A Randomized, Double-blind, Phase 2, Dose-finding Trial of Once Weekly Petrelintide Compared With Placebo in Participants With Obesity or Overweight With Weight Related Comorbidities

Lead sponsor

Zealand Pharma

Asset

Petrelintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

493

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06662539

Org study IDZP8396-23094

Secondary ID2024-512549-18

Timeline

Milestones

Study first posted2024-10-29actual

Study start2024-12-09actual

Primary completion2025-09-30actual

Study completion2026-03-07actual

Last update posted2026-03-23actual

Assets

Investigational agents

Petrelintide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

6 endpoints

Primary/protocol endpoint

Percent change from baseline in body weight to Week 28

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42

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

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

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

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight to Weeks 28 and 42

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference to Weeks 28 and 42

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

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight to Week 42

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

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

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

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in fasting glucose to Week 42

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

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

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

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint/low confidence

Change from baseline in fasting lipids to Week 42

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

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Occurrences of anti-drug antibodies (ADAs) to petrelintide

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

Immunogenicity (ADA)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.