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

NCTNCT06926842Other idZP8396-24115

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 221 participants (actual)
Sponsor: Zealand Pharma · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 22 Apr 2025
Primary completion: 13 Aug 2026
Completion: 13 Aug 2026
First posted: 15 Apr 2025
Last update posted: 9 Sept 2026
Conditions: Overweight · Type 2 Diabetes · Obesity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

Ph 2
Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)
NCT06926842
22 Apr 2025 to 13 Aug 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 investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.

Interventions

PetrelintideDrug
PlaceboOther

Arms6

Experimental
Treatment A: Petrelintide Dose 1
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.
Placebo comparator
Treatment B: Petrelintide Placebo Dose 1
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Experimental
Treatment C: Petrelintide Dose 2
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.
Placebo comparator
Treatment D: Petrelintide Placebo Dose 2
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Experimental
Treatment E: Petrelintide Dose 3
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
Placebo comparator
Treatment F: Petrelintide Placebo Dose 3
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage Change in Body Weight
Time frame · From Baseline (Day 1) to Weeks 28

Secondary outcomes(15)

Number of Participants Achieving ≥5% Body Weight Loss
Time frame · From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≥10% Body Weight Loss
Time frame · From Baseline (Day 1) to Weeks 28
Change in Body Weight (kilogram)
Time frame · From Baseline (Day 1) to Weeks 28
Change in Waist Circumference
Time frame · From Baseline (Day 1) to Weeks 28
Change in Glycated Hemoglobin (HbA1c)
Time frame · From Baseline (Day 1) to Weeks 28
Change in Fasting Glucose
Time frame · From Baseline (Day 1) to Weeks 28
Change in High-Sensitivity C-reactive protein (hsCRP)
Time frame · From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≤6.5% HbA1c
Time frame · From Baseline (Day 1) to Weeks 28
Changes in Fasting Lipids
Time frame · 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
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
Number of Participants with Positive Anti-Drug Antibodies (ADAs)
Time frame · From Baseline (Day 1) to Weeks 38
Change in Systolic Blood Pressure
Time frame · From Baseline (Day 1) to Week 38
Change in Diastolic Blood Pressure
Time frame · From Baseline (Day 1) to Week 38
Change in Pulse Rate
Time frame · From Baseline (Day 1) to Week 38

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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