A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME-4)

Roche

Status and phase: Enrolling; Phase 3

Conditions: Obesity or Overweight; Type 2 Diabetes

Treatments: Combination Product: Petrelintide; Combination Product: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07843485

2026-526189-25-00 (EU Trial (CTIS) Number)

CC46369

Details and patient eligibility

About

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).

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Petrelintide

Experimental group

Treatment:

Combination Product: Petrelintide

Placebo

Placebo Comparator group

Treatment:

Combination Product: Placebo