GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 2

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

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

Lead sponsor

Zealand Pharma

Asset

Petrelintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

221

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥27

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 IDNCT06926842

Org study IDZP8396-24115

Timeline

Milestones

Study first posted2025-04-15actual

Study start2025-04-22actual

Last update posted2026-01-15actual

Primary completion2026-08-13estimated

Study completion2026-08-13estimated

Assets

Investigational agents

Petrelintide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

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.

Endpoints (16)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

5 endpoints

Primary/protocol endpoint

Percentage Change in Body Weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Achieving ≥5% Body Weight Loss

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

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving ≥10% Body Weight Loss

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

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Weight (kilogram)

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

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

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in Glycated Hemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Glucose

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Number of Participants Achieving ≤6.5% HbA1c

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

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

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

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

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Changes in Fasting Lipids

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

change from baseline, improvement

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:From Baseline (Day 1) to Week 38

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:From Baseline (Day 1) to Week 38

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Pulse Rate

Time frame:From Baseline (Day 1) to Week 38

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

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

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

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

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

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

Time frame:From Baseline (Day 1) to Weeks 38

Immunogenicity (ADA)

descriptive

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.