RO7204239 + Tirzepatide for Obesity

(GYMINDA Trial)

Not currently recruiting at 38 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a new treatment, RO7204239 (an experimental treatment), combined with tirzepatide, affects weight loss in individuals with obesity or who are overweight. Participants will be divided into groups to receive varying doses of RO7204239 or a placebo, alongside tirzepatide, over 48 weeks. The trial seeks adults who have unsuccessfully attempted weight loss through diet or exercise and have maintained a stable weight recently. It excludes individuals with diabetes or those who have experienced recent significant health issues. Participants should have a body mass index (BMI) of at least 30, or between 27 and 30 with a weight-related health issue such as high blood pressure or sleep apnea. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to the development of new weight loss solutions.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, since all participants will receive tirzepatide as part of the treatment, it's best to discuss your current medications with the trial team to ensure there are no interactions.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that participants taking tirzepatide alone for weight loss generally tolerated it well. Some experienced mild side effects such as nausea, diarrhea, and reduced appetite, but these were usually manageable. RO7204239, the new drug being tested with tirzepatide in this trial, remains under investigation. As a Phase 2 trial, RO7204239 has passed initial safety tests, but further information on its safety in humans is still being gathered. No serious side effects have been reported so far, but more research is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments involving RO7204239 plus tirzepatide for obesity because they offer a fresh approach to tackling weight loss. Unlike standard options like lifestyle modifications or medications solely targeting appetite or metabolic rate, RO7204239 works alongside tirzepatide, which is already known for its role in regulating insulin and appetite. The unique aspect here is the combination therapy, where RO7204239 is administered in varying doses to see how it enhances weight loss when combined with tirzepatide. This multi-pronged approach could lead to more effective long-term weight management solutions.

What evidence suggests that this trial's treatments could be effective for obesity?

Studies have shown that tirzepatide helps people lose weight by mimicking hormones that regulate hunger and insulin. In this trial, participants will receive tirzepatide as a background therapy. Research suggests that RO7204239 might enhance this effect. Participants in different trial arms will receive varying doses of RO7204239 alongside tirzepatide. Early findings indicate that combining RO7204239 with tirzepatide might result in greater weight loss than using tirzepatide alone. This combination aims to enhance weight loss compared to tirzepatide by itself. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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. During the treatment extension period participants will receive placebo for the 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. During the treatment extension period participants will receive placebo for the 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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06965413

NCT06965413 | A Study to Assess Efficacy, Safety, ... The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/metabolic-disorder/obesity/a-study-to-assess-efficacy--safety--tolerability--pharm-17109.html

Clinical trial for Obesity-Genentech A Member of the Roch... 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 ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-ro7204239-and-tirzepatide-for-weight-loss-in-patients-with-obesity-or-overweight-with-a-weight-related-health-issue/

Study on the Effects of RO7204239 and Tirzepatide ... The purpose of the study is to assess how effective this combination is in helping participants lose weight over a period of 48 weeks.

4. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/metabolic-disorder/obesity/a-study-to-evaluate-the-effect-of-ro7204239-on-insulin--95286.pdf

A study to look at how RO7204239 works to reduce certain ... Treatment with RO7204239 alongside diet modification and exercise might lead to improved insulin sensitivity and weight loss. Page 2. © 2022 F. Hoffmann-La ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07137585

NCT07137585 | A Study to Evaluate the Effect of ... The main purpose of this study is to assess the effect of RO7204239 on insulin sensitivity versus placebo in participants with T2DM and obesity or overweight.

6. withpower.com withpower.com/trial/phase-2-overweight-4-2025-349d0

RO7204239 + Tirzepatide for Obesity (GYMINDA 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, ...

7. trialstoday.org trialstoday.org/trial/NCT06965413

A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics ... 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 ...