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A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease

ConditionsObesity or OverweightCardiovascular Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorHoffmann-La Roche

About this trial

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 established cardiovascular disease (CVD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with BMI ≥ 27 kg/m² and established CVD

History of at least one self-reported unsuccessful dietary effort to lose body weight

Disqualifiers

Known history of Type 1 diabetes mellitus

Current or previous treatment with petrelintide or any other amylin analog

Trial design

Design model

Parallel

Treatments tested in this trial

  • Petrelintide

    Combination product

    Petrelintide will be administered subcutaneously (SC) using a drug-device combination product.

  • Placebo

    Combination product

    Petrelintide-matching placebo will be administered SC using a drug-device combination product.

Treatment groups

2,500 Participants
are divided into 2 treatment groups
Group A: PetrelintideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage Change in Body Weight from Baseline

Time frame
From Baseline to Week 64

Secondary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Zealand Pharma

Collaborator

Source ClinicalTrials.gov
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