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

NCT07843485 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CC463692026-526189-25-00
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Obesity or Overweight; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Body Weight from Baseline

  From Baseline to Week 64

Secondary Outcomes (41)

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

  From Baseline to Week 64

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

  From Baseline to Week 64

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

  From Baseline to Week 64

• Change from Baseline in Waist Circumference (cm)

  From Baseline to Week 64

• Change from Baseline in Hemoglobin A1c (HbA1c)

  From Baseline to Week 64

Study Arms (2)

Petrelintide

EXPERIMENTAL

Combination Product: Petrelintide

Placebo

PLACEBO COMPARATOR

Combination Product: Placebo

Interventions

Petrelintide COMBINATION_PRODUCT

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

Also known as: RO7895515, ZP8396

Petrelintide

Placebo COMBINATION_PRODUCT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History or presence of proliferative diabetic retinopathy, or diabetic macular edema
• Current or previous treatment with petrelintide or any other amylin analog

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Zealand Pharma: collaborator

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Reference Study ID Number: CC46369 https://forpatients.roche.com/No attachments to email below.

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 28, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): October 20, 2028
• Study Completion (Estimated): January 19, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09