Recruiting

Phase 3

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

Sponsor:

Hoffmann-La Roche

Code:

NCT07843498

Conditions

Obesity or Overweight

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, at least one weight-related comorbidity, and without Type 2 Diabetes (T2D).

Conditions

Obesity or Overweight

Study ID

NCT07843498

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Mar 22, 2029

Anticipated

Primary completion date

Dec 21, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants with BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight-related comorbidity
History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

HbA1c ≥ 48 mmol/mol (6.5%), measured by the central laboratory at screening
Known history of Type 1 or Type 2 diabetes mellitus
Current or previous treatment with petrelintide or any other amylin analog

Study Design

Enrollment

3900 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: CC46368 https://forpatients.roche.com/No attachments to email below.

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

Locations

Pinnacle Research Group

Recruiting

Anniston, Alabama, United States, 36207

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Clinical Research Associates

Recruiting

Nashville, Tennessee, United States, 37203

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.