RO7204239 + Tirzepatide for Obesity

(GYMINDA Trial)

Recruiting at 10 trial locations

Overseen By Reference Study ID Number: BC45538 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must be taking: Tirzepatide

Disqualifiers: Diabetes, Cardiovascular, Endocrine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

234 Participants Needed

Trial Summary

What is the purpose of this trial?

The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with obesity or overweight and at least one weight-related health issue, but not diabetes. Participants will be tested over a period that includes treatment phases and follow-up.

Inclusion Criteria

History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight

Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11 pounds [lbs]) within 3 months prior to screening

My BMI is 30 or higher.

Exclusion Criteria

Obesity induced by other endocrinologic disorders

Participation in unbalanced/extreme diets

Known clinically significant gastric emptying abnormality

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Core Treatment

Participants receive tirzepatide as background treatment and are randomized to one of the 4 treatment arms for 48 weeks

48 weeks

Weekly visits for tirzepatide administration

Treatment Extension

Participants stop treatment with tirzepatide and continue with RO7204239 or placebo for 24 weeks

24 weeks

Every 4 weeks for RO7204239 or placebo administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

• RO7204239

Trial Overview The study tests the effectiveness of RO7204239 combined with tirzepatide versus a placebo with tirzepatide on weight loss over 48 weeks in participants without diabetes.

Participant Groups

Group I: RO7204239 medium dose + Tirzepatide Experimental Treatment 2 Interventions

Participants will receive RO7204239, medium dose, SC, Q4W for the core treatment period of 48 weeks and the treatment extension period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks.

Group II: RO7204239 low dose + Tirzepatide Experimental Treatment 2 Interventions

Participants will receive RO7204239, low dose, SC, Q4W for the core treatment period of 48 weeks and the treatment extension period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks.

Group III: RO7204239 high dose + Tirzepatide Experimental Treatment 2 Interventions

Participants will receive RO7204239, high dose, SC, Q4W along with tirzepatide, given as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks. During the treatment extension period participants will be randomized to receive RO7204239 or matching placebo, SC, Q4W for 24 weeks.

Group IV: Placebo + Tirzepatide Active Control 3 Interventions

Participants will receive RO7204239 matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for the core treatment period of 48 weeks and the treatment extension period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, every week (QW) during the core treatment period of 48 weeks.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University