Study on the Effectiveness of Survodutide for Weight Loss in Adults with Obesity Without Diabetes

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for people living with obesity who do not have type 2 diabetes. The treatment being tested is called BI 456906, also known as survodutide, and it is given as a solution for injection under the skin. The purpose of the study is to see if this treatment can help participants lose weight when combined with a reduced-calorie diet and increased physical activity.

Participants in the study will receive either the BI 456906 treatment or a placebo. The study will last for 76 weeks, during which time the effects of the treatment on body weight will be closely monitored. The main goal is to determine if BI 456906 is more effective than the placebo in helping participants achieve weight loss. The study will also look at other health factors, such as changes in waist size and blood pressure.

This trial is designed to provide valuable information about the safety and effectiveness of BI 456906 as a potential treatment for obesity. By participating, individuals will contribute to research that may lead to new ways to manage weight and improve health outcomes for people with obesity.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, a healthcare professional will explain the study details, including the purpose, procedures, and duration. Consent forms are reviewed and signed.

Baseline measurements are taken, including body weight, waist circumference, and blood pressure. These measurements help establish a starting point for the study.

2 medication administration

Participants receive the study medication, BI 456906, or a placebo. The medication is administered as a solution for injection under the skin, known as subcutaneous use.

The dosage and frequency of the medication are determined by the study protocol. Participants are instructed on how to self-administer the injections if required.

3 diet and activity guidance

Participants receive guidance on following a reduced-calorie diet and increasing physical activity. These lifestyle changes are part of the study to assess the medication’s effectiveness in conjunction with these efforts.

4 regular follow-up visits

Regular follow-up visits are scheduled throughout the 76-week study period. During these visits, healthcare professionals monitor progress, collect data, and address any concerns.

Measurements such as body weight, waist circumference, and blood pressure are repeated to track changes over time.

5 final assessment

At the end of the 76-week period, a final assessment is conducted. This includes a comprehensive evaluation of the participant’s progress and any changes in health status.

The primary goal is to determine the percentage change in body weight and assess whether a weight reduction of 5% or more has been achieved.

Who Can Join the Study?

Must be a male or female who is at least 18 years old at the time of signing the consent form. In some countries, you must be older if the legal age of consent is more than 18 years.
Must have a Body Mass Index (BMI) of 30 kg/m² or higher. BMI is a measure of body fat based on height and weight.
If your BMI is between 27 and 30 kg/m², you must have at least one of the following weight-related health issues:
- Hypertension: High blood pressure, which is either measured as 140/90 mmHg or higher without medication, or controlled with medication.
- Dyslipidaemia: Abnormal levels of lipids (fats) in the blood, requiring medication to maintain normal levels, or specific cholesterol and triglyceride levels.
- Obstructive sleep apnoea: A condition where breathing stops and starts during sleep.
- Cardiovascular disease (CVD): Includes heart failure, history of stroke, heart attack, coronary artery disease, or peripheral vascular disease.
- Non-alcoholic steatohepatitis (NASH): A liver condition confirmed by a liver test within the last 6 months.
Must have a history of at least one self-reported unsuccessful attempt to lose weight through diet.
Additional criteria may apply.

Who Cannot Join the Study?

Participants cannot have Type 2 Diabetes Mellitus (T2DM). This is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Participants must not have a Body Mass Index (BMI) below 27 kg/m². BMI is a measure of body fat based on height and weight.
Participants with a BMI of 27 kg/m² or higher must have at least one weight-related health issue, such as high blood pressure or high cholesterol, but they cannot have T2DM.
Participants must be within the age range of 18 to 65 years old.
Both male and female participants are eligible, but they must not be part of a vulnerable population, which includes groups like pregnant women or those unable to consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Health Step Finland Oy	Kuopio	Finland
Ośrodek Badań Klinicznych “METABOLICA” lek. Robert Witek	Tarnow	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium
Algemeen Stedelijk Ziekenhuis Campus Aalst	Aalst	Belgium
MVZ im Altstadt-Carree Fulda GmbH	Fulda	Germany
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Sint Franciscus Vlietland Groep Stichting	Rotterdam	The Netherlands
KliFoCenter GmbH	Witten	Germany
Region Oerebro Laen	Orebro	Sweden
Ko-Med Centra Kliniczne Sp. z o.o.	Zamosc	Poland
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Clinical Research Services Turku CRST Oy	Turku	Finland
InnoDiab Forschung GmbH	Essen	Germany
Lukmed 2 Sp. z o.o.	Siedlce	Poland
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH	Oldenburg In Holstein	Germany
Region Stockholm – SLSO	Stockholm	Sweden
StudyCor Oy	Jyvaskyla	Finland
PharmaSite AB	Malmo	Sweden
Stift Carlanderska Sjukhuset	Gothenburg	Sweden
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
Lotzuwcx Ai	Boras	Sweden
Unflvbcqqknz Mvzggws Caeqznt Ggxesaswu	Groningen	The Netherlands
Psaxuva Tsvsv &zzqo Rzijolzonsv Bwkg	Beek Lb	The Netherlands
Eur Ldkzcl	Lublin	Poland
Hcuajmbx Ucrqptdmpt Czvrqcv Hninjkag	Helsinki	Finland
Umooswxffq Ol Aqkoebz	Edegem	Belgium
Cjhyuen Bvqal Kifkasrgfiq Paqpnouj Sjc z olxd	Gdansk	Poland
Tpxoli Zsnvcyerecgkax Spwwsajyi	Hoogeveen	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	09.04.2024
Finland	Not recruiting	09.04.2024
Germany	Not recruiting	09.04.2024
Poland	Not recruiting	09.04.2024
Sweden	Not recruiting	09.04.2024
The Netherlands	Not recruiting	09.04.2024

Trial locations

Survodutide is a medication being studied to help people who are overweight or have obesity. It is given as an injection under the skin. The goal of using survodutide is to help people lose weight when combined with a diet that has fewer calories and more physical activity. This medication is being tested to see if it is safe and effective for people who do not have type 2 diabetes but have a high body mass index (BMI) or other weight-related health issues. The study is looking at how well survodutide works compared to not using any active medication. The hope is that survodutide will help people lose more weight than those who do not receive the active treatment.

Investigated diseases:

Obesity

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically defined by a Body Mass Index (BMI) of 30 or higher. The progression of obesity involves an increase in body weight and fat mass over time, often due to an imbalance between calorie intake and energy expenditure. As obesity progresses, it can lead to changes in body shape and size, and may contribute to the development of other health issues. The condition can affect various bodily systems, including metabolic, cardiovascular, and musculoskeletal systems. Obesity is influenced by a combination of genetic, environmental, and lifestyle factors.

Trial ID:

2022-502529-17-00

Protocol code:

1404-0038

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Survodutide for Weight Loss in Adults with Obesity Without Diabetes

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