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Study comparing RO7795081 and semaglutide with placebo in adults with type 2 diabetes mellitus

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Type 2 Diabetes Mellitus, a condition where the body has problems controlling blood sugar levels. The research will test a new medication called RO7795081 and compare it with both Rybelsus (containing semaglutide) and placebo. The purpose is to determine how well RO7795081 works in controlling blood sugar levels in diabetes patients.

The study will last 30 weeks, during which participants will take their assigned medication once daily by mouth. The medications come in different forms - RO7795081 as hard capsules and Rybelsus as tablets. The study will measure changes in HbA1c (a measure of average blood sugar levels over the past few months) and body weight, among other health indicators.

Throughout the study period, participants will need to visit the clinic regularly for health check-ups. These visits will include blood tests to measure blood sugar control, body weight measurements, and monitoring for any side effects. The study is designed as a double-blind trial, which means neither the participants nor most of the healthcare providers will know which treatment each person is receiving.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your participation in the study begins after confirming that you meet the following requirements:

    - You have had type 2 diabetes for at least 6 months

    - Your blood sugar level (HbA1c) is between 7% and 10.5%

    - You are managing diabetes with diet and exercise alone, or taking metformin and/or SGLT-2 inhibitors for at least 3 months

    - Your body mass index (BMI) is 23.0 or higher

    - Your weight has been stable in the past 3 months (no more than 5% change)

  2. Step 2

    Treatment phase

    The treatment phase lasts for 30 weeks

    You will receive one of the following medications:

    - RO7795081 (capsules taken by mouth)

    - Rybelsus (tablets containing semaglutide in doses of 3 mg, 7 mg, or 14 mg taken by mouth)

    - A placebo (inactive substance)

    The medication should be taken once daily as directed

  3. Step 3

    Monitoring

    Throughout the study, medical staff will monitor:

    - Changes in your blood sugar levels (HbA1c)

    - Your fasting blood sugar levels

    - Changes in your body weight

    - Any side effects or health concerns

    - Your heart activity through ECG measurements

    - Standard laboratory tests and vital signs

  4. Step 4

    Study completion

    The study ends after the 30-week treatment period

    Final assessments will measure:

    - Your final blood sugar levels

    - Total weight change

    - Overall health status

    - Any side effects experienced during the study

Who can join the trial?

7 criteria

  • You must have been diagnosed with Type 2 Diabetes for at least 6 months before screening according to medical standards
  • Your HbA1c level (a blood test that measures your average blood sugar levels over the past 2-3 months) must be between 7% and 10.5% at screening

  • You must either:

    • Be managing your diabetes with diet and exercise alone, or
    • Be taking a stable dose of metformin (a diabetes medication) and/or SGLT-2 inhibitors (medications that help remove sugar through urine) for at least 3 months before screening
  • Your BMI (Body Mass Index, a measure of body fat based on height and weight) must be 23.0 kg/m2 or higher at screening
  • Your body weight must have been stable in the past 3 months (no more than 5% weight gain or loss)
  • You must agree to follow the study's contraception requirements
  • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • History of type 1 diabetes (an autoimmune condition where body cannot produce insulin)
  • Currently pregnant or breastfeeding women
  • Severe kidney disease (poor kidney function)
  • Severe liver disease (poor liver function)
  • Uncontrolled blood pressure (consistently high readings above 140/90)
  • History of heart attack or stroke in the past 6 months
  • Current cancer or cancer treatment
  • Taking insulin therapy
  • Participation in other clinical trials within the past 30 days
  • Known allergic reactions to similar medications
  • Severe mental health conditions that could affect participation
  • HbA1c (average blood sugar) levels below 7% or above 10%
  • Substance abuse within the past year
  • Unable to follow study procedures or attend scheduled visits
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Investigated drugs

  • Rybelsus tablets (semaglutide)

    is an oral medication that contains semaglutide, a type of drug called a GLP‑1 receptor agonist. It works by helping the pancreas release more insulin when blood sugar is high and by slowing down how quickly sugar is absorbed from food. In this study, it is used as a standard treatment (comparator) so researchers can see how the new test drug compares to a medicine that is already known to lower blood sugar in people with type 2 diabetes.

  • RO7795081

    is an experimental, oral GLP‑1 receptor agonist being tested for the first time in people with type 2 diabetes. The drug is taken as a hard capsule once a day. The trial is looking at whether RO7795081 can safely lower blood sugar levels and improve overall diabetes control over a 30‑week period. It is the test medication whose effectiveness and safety are compared against the standard treatment and placebo.

What is already known about the treatment

RO7795081 - An investigational medication being studied for the treatment of Type 2 Diabetes Mellitus, administered once daily. This novel compound is currently undergoing Phase II clinical trials to evaluate its effectiveness in reducing glycated hemoglobin (HbA1c) levels in diabetic patients. While the exact molecular mechanism of action is still being studied through clinical research, the medication is being tested in a controlled environment alongside placebo and active comparators to assess its efficacy, safety, and tolerability over a 30-week treatment period. The drug represents a potential new therapeutic option in diabetes management, though it has not yet received regulatory approval for general medical use.

Investigated diseases

Type 2 Diabetes Mellitus - A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or reduced insulin production. The condition typically develops gradually, with the pancreas initially producing more insulin to compensate for insulin resistance. Over time, the body becomes increasingly unable to properly process glucose from food, leading to elevated blood sugar levels. The condition often develops in adulthood and is associated with factors such as obesity, physical inactivity, and genetic predisposition. Common manifestations include increased thirst, frequent urination, fatigue, and slow-healing wounds.
Trial detailsLast updated 27 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520322-11-00Protocol codeBP45703Estimated enrolment236 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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