RO7795081 for Type 2 Diabetes

Recruiting at 47 trial locations

Overseen By Reference Study ID Number: BP45703 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must be taking: Metformin, SGLT-2 inhibitors

Must not be taking: Other anti-hyperglycemics

Disqualifiers: Type 1 diabetes, Retinopathy, Nephropathy, Neuropathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 30 weeks

240 Participants Needed

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 determine its effectiveness in controlling blood sugar in people with Type 2 diabetes. Researchers aim to assess the treatment's safety and efficacy compared to a placebo and the current medication, semaglutide. Individuals who have had Type 2 diabetes for at least six months and manage it with diet, exercise, or certain medications might be suitable candidates. The study includes different groups to test various doses of the treatment. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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

You can continue taking metformin or SGLT-2 inhibitors, but you must stop any other diabetes medications at least 3 months before joining the trial.

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

Research shows that RO7795081 is being tested for safety and tolerability in people with Type 2 diabetes. Earlier studies assessed responses to ensure safety. Although detailed safety information is not yet available, RO7795081's progression to a Phase 2 trial indicates it has passed initial safety tests in humans. This phase focuses on determining the right dose and monitoring for side effects. Participants in earlier studies generally tolerated it well, but side effects can occur with any treatment. Prospective participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 diabetes?

RO7795081 is unique because it offers a new approach to treating Type 2 Diabetes by targeting different pathways compared to standard treatments. While most current medications, like metformin or GLP-1 receptor agonists such as semaglutide, work by improving insulin sensitivity or mimicking incretin hormones, RO7795081 targets a novel pathway that may enhance glucose control more effectively. Researchers are excited about this treatment because it has the potential to offer better blood sugar regulation with potentially fewer side effects, providing a promising alternative for patients who may not respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for Type 2 diabetes?

Research has shown that RO7795081 is a promising new treatment for managing blood sugar levels in people with Type 2 Diabetes. Early results suggest it helps stabilize blood sugar levels. This trial tests various dosing regimens of RO7795081 to determine the most effective and safe dose. Researchers are comparing this treatment to semaglutide, a well-known diabetes medication, to assess if RO7795081 can match or surpass its effectiveness in controlling diabetes. The current focus is on identifying the optimal dose that is both effective and easy for patients to manage safely. ^{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 Type 2 diabetes who are looking to improve their blood sugar control. Specific eligibility details aren't provided, but typically participants should be in stable health and not currently participating in other studies.

Inclusion Criteria

Have an HbA1c ≥7% and ≤10.5% at screening

Body mass index (BMI) ≥23.0 kg/m^2 at screening

A stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)

Exclusion Criteria

I haven't taken any diabetes medication other than metformin or SGLT-2 inhibitors in the last 3 months.

Have a known, clinically significant gastric emptying abnormality

My obesity is caused by a specific hormonal disorder or genetic condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RO7795081 or comparator for glycemic control over 30 weeks

30 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 different doses of a new medication called RO7795081 against a placebo and Semaglutide, which is an existing diabetes treatment. Participants will be randomly assigned to one of these options in separate groups.

How Is the Trial Designed?

Group I: Arm 9: RO7795081 Dosing Regimen 7 Experimental Treatment 1 Intervention

Group II: Arm 8: RO7795081 Dosing Regimen 6 Experimental Treatment 1 Intervention

Group III: Arm 7: RO7795081 Dosing Regimen 5 Experimental Treatment 1 Intervention

Group IV: Arm 6: RO7795081 Dosing Regimen 4 Experimental Treatment 1 Intervention

Group V: Arm 5: RO7795081 Dosing Regimen 3 Experimental Treatment 1 Intervention

Group VI: Arm 4: RO7795081 Dosing Regimen 2 Experimental Treatment 1 Intervention

Group VII: Arm 3: RO7795081 Dosing Regimen 1 Experimental Treatment 1 Intervention

Group VIII: Arm 2: Semaglutide 14 mg Active Control 1 Intervention

Group IX: 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/NCT07112872

NCT07112872 | A Study to Compare Different Doses of ... See Delay Results Type in the Results Data ... A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes.

2. forpatients.roche.com forpatients.roche.com/en/trials/metabolic-disorder/t2d/a-study-to-compare-different-doses-of-ro7795081-with-a--74491.html

Clinical trial for Type 2 Diabetes Mellitus-ForPatients b... ... II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).

3. patlynk.com patlynk.com/trial/NCT07112872

RO7795081 for Glycemic Control in Type 2 Diabetes This study is focused on finding out how well a new medication, RO7795081, works in managing blood sugar levels in adults with Type 2 Diabetes.

4. withpower.com withpower.com/trial/phase-2-diabetes-mellitus-type-2-7-2025-e25a8

RO7795081 for Type 2 Diabetes Trial Overview The study tests different doses of a new medication called RO7795081 against a placebo and Semaglutide, which is an existing diabetes treatment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07081958

NCT07081958 | A Study Evaluating the Effect of Daily Oral ... Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period. Participant Group/Arm ...

6. 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 ... Body Mass Index (BMI) ≥27.0 kg/m^2 at screening and on Day -1 of Period 1; Stable body weight (defined as <5% gain or loss) in the 2 months ...

7. 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, ...