Recruiting

Phase 3

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

Sponsor:

Hoffmann-La Roche

Code:

NCT07843485

Conditions

Obesity or Overweight

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Petrelintide

Placebo

Study Details

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

Study ID

NCT07843485

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Jan 19, 2029

Anticipated

Primary completion date

Oct 20, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Petrelintide

placebo comparator: Placebo

Interventions

Petrelintide

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

Placebo

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

Primary outcome measure

Percentage Change in Body Weight from Baseline [ Time Frame: From Baseline to Week 64 ]

Central Contacts and Locations

Central contacts

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

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

Locations

Institute for Metabolic Research Los Angeles

Recruiting

Los Angeles, California, United States, 90015

Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.