Study on the Effectiveness of Survodutide for Weight Loss in Patients with Type 2 Diabetes and Obesity

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called BI 456906 on individuals who are living with overweight or obesity and also have type 2 diabetes. The treatment is administered as a solution for injection under the skin, known as subcutaneous use. The main goal of the study is to see if BI 456906 can help participants lose weight when combined with a reduced-calorie diet and increased physical activity, compared to a placebo.

The study will last for 76 weeks, during which participants will receive either the BI 456906 treatment or a placebo. Throughout the study, participants will be monitored to assess changes in their body weight and other health indicators. The study aims to determine if the treatment can lead to a significant reduction in body weight and improve other health measures related to type 2 diabetes.

Participants will be evaluated on various outcomes, including the percentage change in body weight and the achievement of specific weight loss goals. The study will also look at changes in waist circumference, blood sugar levels (measured by HbA1c), and other health-related scores. This research is important for understanding how BI 456906 might help people with overweight or obesity and type 2 diabetes manage their weight and improve their overall health.

1 joining the study

Upon joining the study, participants will be randomly assigned to receive either the study medication, BI 456906, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

2 medication administration

The medication, BI 456906, is administered as a solution for injection. It is given through a method called subcutaneous use, which means it is injected under the skin.

Participants will receive the medication or placebo regularly as part of the study protocol. The exact dosage and frequency will be determined by the study team and communicated to participants.

3 diet and physical activity

Participants are expected to follow a reduced-calorie diet and increase their physical activity as part of the study. These lifestyle changes are important components of the trial and will be monitored throughout the study period.

4 regular check-ups

Participants will attend regular check-ups to monitor their health and the effects of the medication. These check-ups will include measurements of body weight, waist circumference, and other health indicators.

Blood tests will be conducted to measure HbA1c, which is a marker of blood sugar levels, and other relevant health parameters.

5 study duration

The study will last for a total of 76 weeks. During this time, participants will continue to receive the study medication or placebo and follow the prescribed diet and exercise regimen.

The primary goal is to assess the percentage change in body weight and the achievement of specific weight reduction targets by the end of the study period.

6 end of study

At the end of the study, participants will undergo a final assessment to evaluate the overall effects of the treatment. This will include a review of weight changes, health markers, and any side effects experienced during the trial.

Participants will be informed of the study results and any further steps, if applicable.

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 27 kg/m2 or higher. BMI is a measure of body fat based on height and weight.
  • Must have been diagnosed with Type 2 Diabetes Mellitus (T2DM) at least 180 days before the screening. This is confirmed by a blood test called glycosylated hemoglobin A1c (HbA1c), which should be 6.5% (48 mmol/mol) or higher.
  • At the screening, the HbA1c level should be between 6.5% (48 mmol/mol) and less than 10% (86 mmol/mol).
  • Must currently be treated for T2DM with either diet and exercise alone or stable treatment for at least 3 months with medications such as metformin, sodium-glucose cotransporter-2 inhibitor (SGLT2i), acarbose, sulfonylurea, or glitazone. These can be used alone or in combination, up to three medications.
  • 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?

  • Having a medical condition other than Type II Diabetes Mellitus or Obesity that could interfere with the study.
  • Being under the age of 18 or over the age of 65.
  • Being pregnant or planning to become pregnant during the study period.
  • Having a history of severe allergic reactions to any of the study medications.
  • Currently participating in another clinical trial.
  • Having a significant medical condition that the study doctor believes would make it unsafe to participate.
  • Having a history of drug or alcohol abuse within the past year.
  • Being unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Private Practice – Dr. Barbora Diepoltova Prague Czechia
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium
MVZ im Altstadt-Carree Fulda GmbH Fulda Germany
Ośrodek Badań Klinicznych “METABOLICA” lek. Robert Witek Tarnow Poland
Diabeteszentrum Hamburg West Hamburg Germany
Health Step Finland Oy Kuopio Finland
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain
DIEKO s.r.o. Plzen Czechia

Other Sites

Site Name City Country Status
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Sanos A/S Gandrup Denmark
Region Oerebro Laen Orebro Sweden
Hospital General Universitario Gregorio Maranon Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Lukmed 2 Sp. z o.o. Siedlce Poland
Region Stockholm – SLSO Stockholm Sweden
DRC Kft. Balatonfured Hungary
Edumed s.r.o. Nachod Czechia
PharmaSite AB Malmo Sweden
Belinus Bt. Debrecen Hungary
Stift Carlanderska Sjukhuset Gothenburg Sweden
Thermi Clinic S.A. Thessaloniki Greece
InnoDiab Forschung GmbH Essen Germany
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Stichting Treant Ziekenhuiszorg Emmen The Netherlands
KliFoCenter GmbH Witten Germany
Hospital Universitario De Canarias La Laguna Spain
Vrije Universiteit Brussel Jette Belgium
Clinical Research Services Turku CRST Oy Turku Finland
Centrum Medyczne Kuba-Med 2 Sp. z o.o. Zamosc Poland
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
University Of Szeged Szeged Hungary
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
DermaMed Research Kft. Oroshaza Hungary
Mlcna Kvyjct skbrdq Prague Czechia
Unnzkvrphmov Mmpdfjn Cfuqjge Gqihojndh Groningen The Netherlands
Hnvkruig Hgamhisd Hvidovre Denmark
Cbukepj Bxnib Kdutnjeydji Pawddwgz Snz z okrx Gdansk Poland
Ptgtoqo Tvmnp &polf Rztmpgkzebg Bncg Beek Lb The Netherlands
Anmxhcnv Silwowv Pic sjpoc s rohr Lazce Czechia
Hiuugimr Umwdglntbu Cvqfyoc Hgetcrjw Helsinki Finland
Ajilrf Mrvmbhj Csyffy Skbe Thessaloniki Greece
Loetmytq Ad Boras Sweden
Hdgehayn Huvirccp Hillerød Denmark
Hdpoewyp Ugfqpltruckfb dr A Ccyzbk A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
10.01.2024
Czechia Czechia
Not recruiting
10.01.2024
Denmark Denmark
Not recruiting
10.01.2024
Finland Finland
Not recruiting
10.01.2024
Germany Germany
Not recruiting
10.01.2024
Greece Greece
Not recruiting
10.01.2024
Hungary Hungary
Not recruiting
10.01.2024
Poland Poland
Not recruiting
10.01.2024
Spain Spain
Not recruiting
10.01.2024
Sweden Sweden
Not recruiting
10.01.2024
The Netherlands The Netherlands
Not recruiting
10.01.2024

Trial locations

Investigated drugs:

Survodutide is a medication being studied to help people who are overweight or have obesity, and also have type 2 diabetes. It is given as an injection under the skin. The goal of using survodutide is to see if it can help people lose weight when combined with a diet that has fewer calories and more physical activity. The study is looking at how well survodutide works, how safe it is, and how well people can tolerate it compared to a placebo, which is a substance with no active medication. The researchers want to find out if survodutide can help people lose more weight than the placebo. This medication is being tested in different amounts to see which works best.

Investigated diseases:

Diabetes mellitus type II – This is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body’s cells do not respond properly to insulin, leading to elevated blood glucose levels. Over time, the pancreas may not produce enough insulin to maintain normal glucose levels. The disease often develops gradually and can be influenced by factors such as obesity, physical inactivity, and genetics. Symptoms may include increased thirst, frequent urination, and fatigue. If not managed, it can lead to complications affecting various organs.

Obesity – This 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. Obesity develops over time when calorie intake exceeds calorie expenditure, often influenced by genetic, behavioral, and environmental factors. It can lead to increased risk of various health issues, including type 2 diabetes, cardiovascular diseases, and certain cancers. The condition can also affect physical mobility and lead to psychological issues such as low self-esteem. Managing obesity often involves lifestyle changes, including diet and physical activity adjustments.

Trial ID:
2022-502531-18-00
Protocol code:
1404-0041
Trial Phase:
Therapeutic confirmatory (Phase III)

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