RO7795081 for Obesity

Not currently recruiting at 36 trial locations

Overseen By Reference Study ID Number: BP45702 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Disqualifiers: Diabetes, Cushing's, Hypertension, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 38 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RO7795081, an experimental therapy, to help manage weight in individuals who are obese or overweight and have at least one weight-related health issue, such as high blood pressure or sleep apnea, but do not have diabetes. Researchers aim to assess the effectiveness and safety of this treatment by comparing it to a placebo (a harmless pill with no active drug) and different doses of the treatment. Individuals who have attempted and struggled to lose weight through diet and exercise, and have maintained a stable weight for the last three months, might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to important early findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that RO7795081 has been tested for safety in individuals who are overweight or have obesity. In these studies, most participants tolerated the treatment well. Serious side effects rarely occurred, though some experienced mild to moderate issues like nausea or headaches, which were uncommon.

The treatment remains under investigation, with promising evidence of its safety so far. This stage of research typically indicates that the treatment has passed initial safety checks and is now undergoing closer examination to ensure its efficacy and safety for regular use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about RO7795081 for obesity because it potentially offers a new approach where existing treatments often focus on appetite suppression or fat absorption. Unlike these conventional methods, RO7795081 may target different metabolic pathways, which could lead to more effective weight management. This unique mechanism might also reduce some side effects commonly associated with current obesity medications, offering a promising new option for those struggling with weight issues.

What evidence suggests that RO7795081 might be an effective treatment for obesity?

Research has shown that RO7795081 is designed to help individuals who are obese or overweight manage their weight. Early studies found that this treatment can reduce body weight by influencing how the body processes certain fats and cholesterol. Initial results indicated that participants taking RO7795081 lost weight without serious side effects. Although the full effectiveness is still under investigation, these early findings are promising for those seeking weight management solutions. Participants in this trial will receive one of several dosing regimens of RO7795081 or a placebo to further evaluate its effectiveness and safety. ^{1 2 3 5 6}

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 who also have a weight-related health issue, but not diabetes. Participants should be looking to manage their weight long-term.

Inclusion Criteria

My BMI is 27 or higher and I may have a weight-related health issue.

History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)

Exclusion Criteria

Have a known, clinically significant gastric emptying abnormality

I haven't had a heart attack, stroke, severe chest pain, or heart failure hospitalization in the last 3 months.

I have been diagnosed with a form of diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RO7795081 or placebo for chronic weight management

38 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RO7795081

Trial Overview The study tests the effects of RO7795081, taken daily by mouth, against a placebo. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug or placebo.

How Is the Trial Designed?

Group I: Arm 8: RO7795081 Dosing Regimen 7 Experimental Treatment 1 Intervention

Group II: Arm 7: RO7795081 Dosing Regimen 6 Experimental Treatment 1 Intervention

Group III: Arm 6: RO7795081 Dosing Regimen 5 Experimental Treatment 1 Intervention

Group IV: Arm 5: RO7795081 Dosing Regimen 4 Experimental Treatment 1 Intervention

Group V: Arm 4: RO7795081 Dosing Regimen 3 Experimental Treatment 1 Intervention

Group VI: Arm 3: RO7795081 Dosing Regimen 2 Experimental Treatment 1 Intervention

Group VII: Arm 2: RO7795081 Dosing Regimen 1 Experimental Treatment 1 Intervention

Group VIII: Arm 1: Placebo Placebo Group 1 Intervention

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/NCT07081958

NCT07081958 | A Study Evaluating the Effect of Daily Oral ... A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity. ClinicalTrials ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/metabolic-disorder/obesity/a-study-evaluating-the-effect-of-daily-oral-ro7795081-i-63928.html

Clinical trial for Obesity-Genentech A Member of the Roch... A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity. Metabolic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06982131

A Study Investigating the Safety of RO7795081 and ... This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, ...

4. trialx.com trialx.com/clinical-trials/listings/299167/a-study-investigating-the-safety-of-ro7795081-and-the-effect-of-ro7795081-on-how-the-body-processes-pitavastatin-and-rosuvastatin-in-otherwise-healthy-overweight-or-obese-adult-participants/

A Study Investigating the Safety of RO7795081 and ... ... Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants.

5. forpatients.roche.com forpatients.roche.com/en/trials/metabolic-disorder/obesity/a-study-investigating-the-safety-of-ro7795081-and-the-e-56948.html

Clinical trial for Obesity-ForPatients by Roche A study investigating the safety of RO7795081 and the effect of RO7795081 on how the body processes pitavastatin and rosuvastatin in otherwise healthy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07081958

NCT07081958 | A Study Evaluating the Effect of Daily Oral ... A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity. ClinicalTrials ...