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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

8 criteria

  • 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.
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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.

What is already known about the treatment

Survodutide – Survodutide is administered through an injection under the skin, known as subcutaneous administration. It is currently being studied in clinical trials to assess its effectiveness and safety for people with type 2 diabetes and obesity. The main purpose of this medication is to help manage weight and improve blood sugar levels in these individuals. Survodutide works by influencing certain hormones in the body that control appetite and metabolism, helping to reduce hunger and increase energy use. It is classified as a medication for diabetes and weight management.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502531-18-00Protocol code1404-0041Estimated enrolment756 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

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