Recruiting

RO7795081 for Glycemic Control in Type 2 Diabetes

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What is being tested

RO7795081

+ Semaglutide

+ Placebo

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Study ContactReference Study ID Number: BP45703 https://forpatients.roche.com/
Last updated: January 16, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 19, 2025

Actual date on which the first participant was enrolled.

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. The aim is to see if this medication can help people with this condition maintain better control of their blood sugar, which is crucial for preventing complications like heart disease, nerve damage, and other serious health issues. The study is important because it explores a potential new treatment option that could improve the quality of life for people with Type 2 Diabetes. Participants in the study will be randomly assigned to receive either the actual medication, a placebo, or another active treatment in a way that neither the participants nor the researchers know who is receiving which treatment. This is done to ensure the results are unbiased. The medication is given once a day for 30 weeks, and the study will monitor how well it helps control blood sugar levels, as well as how safe and tolerable it is for participants. The study will carefully check for any side effects to ensure that the treatment is safe for use.

Official TitleA Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants With Type 2 Diabetes Mellitus 
NCT07112872
Principal SponsorHoffmann-La Roche
Study ContactReference Study ID Number: BP45703 https://forpatients.roche.com/
Last updated: January 16, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months before screening
Have an HbA1c ≥7% and ≤10.5% at screening
Management of T2D with diet and exercise alone or with either a stable dose of metformin or/and sodium-glucose cotransporter-2 (SGLT-2) inhibitors
Body mass index (BMI) ≥23.0 kg/m^2 at screening
Show More Criteria
9 exclusion criteria prevent from participating
Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
History or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
Evidence of clinically significant/active nephropathy or neuropathy (including resting tachycardia, orthostatic hypotension, and diabetic diarrhea)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

9 intervention groups are designated in this study

11.111% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in this group will take RO7795081, a study drug, once a day by mouth for a period of 30 weeks.

Group II

Experimental
Participants in this group will take RO7795081 once a day by mouth, following a specific dosing plan, for a period of 30 weeks.

Group III

Experimental
Participants in this group will take RO7795081, a new investigational drug, once a day by mouth for a 30-week treatment period.

Group IV

Experimental
Participants in this group take RO7795081 once a day by mouth for a 30-week period.

Group 5

Experimental
Participants in this group will take RO7795081, a new investigational drug, once a day by mouth for a period of 30 weeks.

Group 6

Experimental
Participants in this group will take RO7795081 once a day by mouth, following the assigned dosing plan, for a treatment period of 30 weeks.

Group 7

Experimental
Participants in this group will take RO7795081 once a day, as per their assigned dosing regimen, for a period of 30 weeks.

Group 8

Active Comparator
Participants in this group will take Semaglutide 14 mg orally once daily, with dosage adjustments as per label instructions, for a period of 30 weeks.

Group 9

Placebo
Participants in this group receive a placebo, a pill with no active medication, taken once daily for 30 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 51 locations

Recruiting

Arizona Liver Health - Tucson

Tucson, United StatesSee the location
Recruiting

Orange County Research Center

Lake Forest, United States
Recruiting

Prospective Research Innovations Inc.

Rancho Cucamonga, United States
Recruiting

Encompass Clinical Research

Spring Valley, United States
Recruiting
51 Study Centers