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

ConditionsObesity or OverweightType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
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 with Type 2 Diabetes (T2D).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History or presence of proliferative diabetic retinopathy, or diabetic macular edema

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

600 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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