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-Controlled
Phase 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, 2025Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Metabolic Diseases
Nutritional and Metabolic Diseases
Glucose 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.

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
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.

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
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.

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
Group IV
Experimental
Participants in this group take RO7795081 once a day by mouth for a 30-week period.

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment 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.

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
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.

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
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.

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
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.

Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
Group 9
Placebo
Participants in this group receive a placebo, a pill with no active medication, taken once daily for 30 weeks.

Placebo will be taken orally QD during the 30-week treatment period.
Study Objectives
Primary Objectives

This study measures how much the blood sugar levels change from the start to the end of 30 weeks. This is important because it shows how well the drug RO7795081 controls blood sugar compared to a placebo.
Secondary Objectives

This study measures how much a blood sugar marker, HbA1c, changes from the start to the end of 30 weeks. This helps patients understand which drug, RO7795081 or Semaglutide, works better for controlling blood sugar levels.

This measures the percentage of participants who have reached healthy blood sugar levels (HbA1c <5.7%, ≤6.5%, and <7.0%) after 30 weeks. This matters to patients because reaching these levels can reduce the risk of complications from diabetes.

This measures how much the blood sugar level, when not eating, changes from the start to the end of 30 weeks. This is important because it helps show how well a treatment is working in managing diabetes.

This measures how much your body weight has increased or decreased after 30 weeks of treatment. This is important because changes in body weight can affect your overall health and well-being.

This measures how much your weight has increased or decreased from the start to the end of the 30-week period. This is important because changes in weight can show if a treatment is working or not, and can also affect your overall health.

This measures the percentage of participants who lose 5%, 10%, or 15% of their starting body weight after 30 weeks. This is important because it can show how effective a treatment is for weight loss.

This study looks at how often participants experience side effects, special side effects of interest, and serious side effects. It checks this from the first dose until 28 days after the last dose of the study treatment (34 weeks).

This study measures the amount of RO7795081 in the blood at different times, from before the first dose up to Week 30. This helps us understand how the body processes the drug and how long it stays effective.

This study records the number of participants experiencing low blood sugar levels (categorized as mild, moderate, or severe) from the start of the treatment until 28 days after the final dose. This helps us understand the impact of the treatment on blood sugar control, which is important for patients' overall health.

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 - TucsonTucson, United StatesSee the location
Recruiting
Orange County Research CenterLake Forest, United States
Recruiting
Prospective Research Innovations Inc.Rancho Cucamonga, United States
Recruiting
Encompass Clinical ResearchSpring Valley, United States
Recruiting
51 Study Centers
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