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Active, Not Recruiting

NCT Number: NCT06926842

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cullman Clinical Trials - Family Medicine, Cullman, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Petrelintide

Drug

Petrelintide will be taken by participants once weekly subcutaneously.

Other names: ZP8396

Placebo

Other

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

Primary outcomes

  1. Percentage Change in Body Weight

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

Secondary outcomes

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

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

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

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

  3. Change in Body Weight (kilogram)

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

  4. Change in Waist Circumference

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

  5. Change in Glycated Hemoglobin (HbA1c)

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

  6. Change in Fasting Glucose

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

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

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

  8. Number of Participants Achieving ≤6.5% HbA1c

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

  9. Changes in Fasting Lipids

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

  10. 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

  11. 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

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

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

  13. Change in Systolic Blood Pressure

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

  14. Change in Diastolic Blood Pressure

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

  15. Change in Pulse Rate

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

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Collaborators

  • Parexel

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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