Not recruiting

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.

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)
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
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
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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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
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Hospital Clinic De Barcelona
Barcelona, Spain
Verified
Hospital General Universitario Gregorio Maranon
Madrid, Spain

Trial locations

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Investigated drugs

RO7795081 is an investigational medication being studied for the treatment of Type 2 Diabetes Mellitus. It is designed to be taken once daily and aims to help control blood sugar levels by reducing glycated hemoglobin (HbA1c), which is a measure of average blood sugar levels over the past 2-3 months. Note: Based on the provided source data, only one active medication (RO7795081) is mentioned. The trial includes placebo and an active comparator, but specific details about the active comparator are not provided in the source data.

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.