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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Ośrodek Badań Klinicznych “METABOLICA” lek. Robert Witek	Tarnow	Poland

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Borbanya Praxis Egeszsegugyi Kft.	Nyiregyhaza	Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Area Sanitaria De Ferrol	Ferrol	Spain
Qualiclinic Kft.	Budapest	Hungary
Centrum Medyczne Intercor Sp. z o.o.	Bydgoszcz	Poland
Pro Familia Altera Sp. z o.o.	Katowice	Poland
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
University Of Debrecen	Debrecen	Hungary
Clinexpert Kft.	Budapest	Hungary
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.	Wroclaw	Poland
Centro Medico Teknon-Grupo Quironsalud	Barcelona	Spain
University Of Szeged	Szeged	Hungary
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Osteo Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
Eyatuh Syf z otvu	Lublin	Poland
Hgsvique Uaywocswzqgkw Mexelat De Vwgcikutuo	Santander	Spain
Cubanfi Biwfq Klbnwmuaaxa Puiqwbiw Syn z omuz	Gdansk	Poland
Eqw Zngfqp	Zamosc	Poland
Esq Lrxfsp	Lublin	Poland
Hdovyhpm Vxyf dutawqsh	Barcelona	Spain
Htxyxnoy Utfvweqsjubwr dm A Cgnemx	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	19.10.2025
Poland	Not recruiting	19.10.2025
Spain	Not recruiting	19.10.2025

Trial locations

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.

Investigated diseases:

Type 2 diabetes mellitus

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 ID:

2024-520322-11-00

Protocol code:

BP45703

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?