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Trial · Interventional

RecruitingPhase 3Registry data

A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes

Short name ZUPREME-4

NCTNCT07843485 (opens ClinicalTrials.gov in a new tab)Other idCC46369Other id2026-526189-25-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
600 participants (estimated)
Sponsor
Hoffmann-La Roche · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
30 Sept 2026 (estimated)
Primary completion
20 Oct 2028 (estimated)
Completion
19 Jan 2029 (estimated)
First posted
28 Sept 2026
Last update posted
7 Oct 2026
Conditions
Obesity or Overweight · Type 2 Diabetes

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027202820292030
  1. Ph 3

    ZUPREME-4

    NCT07843485

    est. 30 Sept 2026 to est. 19 Jan 2029

Registry summary

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

This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and with Type 2 Diabetes (T2D).

Interventions

  • PetrelintideCombination product
  • PlaceboCombination product

Arms2

  • Experimental

    Petrelintide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage Change in Body Weight from Baseline

    Time frame · From Baseline to Week 64

Secondary outcomes(20)

  1. Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline

    Time frame · From Baseline to Week 64

  2. Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline

    Time frame · From Baseline to Week 64

  3. Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline

    Time frame · From Baseline to Week 64

  4. Change from Baseline in Waist Circumference (cm)

    Time frame · From Baseline to Week 64

  5. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame · From Baseline to Week 64

  6. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT) Physical Functioning Composite Score

    Time frame · From Baseline to Week 64

  7. Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

    Time frame · From Baseline to Week 64

  8. Change from Baseline in Mean Daily Food Craving Score

    Time frame · From Baseline to Week 64

  9. Change from Baseline in Mean Daily Peak Hunger Score

    Time frame · From Baseline to Week 64

  10. Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Time frame · From Baseline to Week 64

  11. Change from Baseline in Body Mass Index (BMI) (kg/m²)

    Time frame · From Baseline to Week 64

  12. Change from Baseline in Body Weight (kg)

    Time frame · From Baseline to Week 64

  13. Change from Baseline in Waist-to-Hip Ratio

    Time frame · From Baseline to Week 64

  14. Change from Baseline in Waist-to-Height Ratio

    Time frame · From Baseline to Week 64

  15. Change from Baseline in Fasting Insulin

    Time frame · From Baseline to Week 64

  16. Change from Baseline in Fasting Glucose

    Time frame · From Baseline to Week 64

  17. Percentage of Participants Achieving HbA1c of < 5.7%

    Time frame · At Week 64

  18. Percentage of Participants Achieving HbA1c of < 6.5%

    Time frame · At Week 64

  19. Percentage of Participants Achieving HbA1c of < 7%

    Time frame · At Week 64

  20. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol

    Time frame · From Baseline to Week 64

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.

A trial that is still running, or that stopped early, may post results later.

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
Inclusion Criteria: * Participants with BMI ≥ 27 kg/m² * T2D diagnosis as per World Health Organization (WHO) classification (or other locally applicable standards) with HbA1c ≥ 6.5% to ≤ 10% (48-86 mmol/mol), measured by the central laboratory at screening * Stable treatment with either diet and exercise alone, basal insulin, or selected oral glucose-lowering agents, for at least 90 days prior to and during screening * History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * History or presence of proliferative diabetic retinopathy, or diabetic macular edema * Current or previous treatment with petrelintide or any other amylin analog

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