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

3 1

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

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Region Stockholm – SLSO Stockholm Sweden
Sanos A/S Gandrup Denmark
KliFoCenter GmbH Witten Germany
Hospital Universitario De Canarias La Laguna Spain
Stift Carlanderska Sjukhuset Gothenburg Sweden
Htrjerdw Ujeoazibtmror dq A Cxsoez A Coruna Galicia Spain
Hqksmbnl Uhbhhlokgs Colfgsp Hobbtlmw Helsinki Finland
Ayfdeo Mlrsfza Camhvr Sgup Thessaloniki Greece
Uaaahetwwi Ox Sdclxa Szeged Hungary
Rpeusf Omriokf Lnop Orebro Sweden
Uozdghphcfzq Mnlncig Colmsrw Gypcjybvn Groningen The Netherlands
Vwyoz Ukieqxhsqssi Bpzgyva Jette Belgium
Awgsliem Zrqphzeszg Ddtzv Roeselare Belgium
Cuvcgls Bakvt Kvvbjcnxjpq Ptruwomy Shd z oeep Gdansk Poland
Tbqqnm Cvrdmx Sykv Thessaloniki Greece
Ehrteu snczdx Nachod Czechia
Kgzhqydmii Fcwn Ffhfns Ktlfre Kistarcsa Hungary
Muxhd Kivraj sgsnal Prague Czechia
Ivdukapf fmsc Dfwskuleyzcfywywi Mkllfltm Garr Munster Germany
Hmxxpumf Uiikwpmsqmis Advxx Dg Vvxtefhy Dk Lc Gfxmwxzp Twaynqojesb Dy Lhiith Lleida Spain
Ssev Fmvrhtrptl Vzdwgdxlz Gnrlz Sumvvsjlm Rotterdam The Netherlands
Kkbgtp Cgkazu Kwogscwfh Sfg z oqot Zamosc Poland
Sbhlpgqme Tywwnt Znglujtettfmcu Emmen The Netherlands
Lslwhdfg Ab Boras Sweden
Hwgssmkk Hxkoqxxf Hvidovre Denmark
Hgjeacte Hecfxkpv Hillerød Denmark
Eztgklyjqt Gmnramv Cmtots Oq Trguocentdtu Thessaloniki Greece
Caeqpphv Rhijjzfx Sekwgvks Tjule Cmpg Oe Turku Finland
Imxstyda Fkjnpsqbq Gxjl Essen Germany
Lawoxt 2 Sxs z ouwj Siedlce Poland
Cmmcisc Moprerdh Kwfdskbp 2 Sez z oqrr Zamosc Poland
Rlhutp Ibzjqqzw fyjh mlvatykdxpaw Sbcakre unv Fmjnruxcgwb Gxxp Oldenburg In Holstein Germany
Dvf Khla Balatonfured Hungary
Poicfnu Tpmsu &fmpo Rroprjpswlf Buzi Beek Lb The Netherlands
Pqhyxnxumn As Malmo Sweden
Bbdhpqi Bjm Debrecen Hungary
Aqbgc Tdzwj Rnsdqvrw Ktzd Oroshaza Hungary
Detkizljxifgtfm Swordvwdsnhhzdfln Hamburg Germany
Nqi Avensbsz Svmppym Pibq shmjpb Olomouc Czechia

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.

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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