#1 Clinical Trials Search in Europe

SURVODUTIDE

Survodutide (also known as BI 456906) is an investigational medication currently being studied in multiple clinical trials for the treatment of obesity, overweight, and related health conditions like non-alcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This drug is administered as a weekly subcutaneous injection and is being evaluated for its effectiveness in weight loss, improving liver function, and addressing metabolic disorders. Clinical trials are examining different doses of survodutide compared to placebo or other treatments, with participants typically receiving the medication for periods ranging from several months to multiple years while researchers monitor various health outcomes.

# Survodutide: A Comprehensive Guide for Patients Table of Contents – [What is Survodutide?](#what-is-survodutide) – [How Does Survodutide Work?](#how-does-survodutide-work) – [Medical Conditions Treated with Survodutide](#medical-conditions-treated-with-survodutide) – [How Survodutide is Administered](#how-survodutide-is-administered) – [Effectiveness of Survodutide](#effectiveness-of-survodutide) – [Potential Side Effects](#potential-side-effects) – [Ongoing Research](#ongoing-research) – [Who Can Take Survodutide?](#who-can-take-survodutide) What is Survodutide? Survodutide (also known as BI 456906) is an investigational medicine being developed to help people with overweight or obesity and related health conditions [1]. It’s designed to be taken as a weekly injection under the skin (subcutaneous injection). Unlike some currently approved weight loss medications, survodutide is still in clinical trials and is not yet approved by regulatory agencies for general use. Multiple studies are ongoing to determine its safety and effectiveness in various populations and medical conditions [2]. How Does Survodutide Work? While the exact mechanism isn’t fully detailed in the current clinical trials, survodutide appears to work by affecting how the body uses energy and breaks down fat [3]. One study specifically examines survodutide’s effects on: – Energy expenditure – how much energy your body uses at rest and during activity – Fatty acid oxidation – how efficiently your body breaks down fat for energy [3] These mechanisms may explain why survodutide can help with weight loss and potentially improve related health conditions. Medical Conditions Treated with Survodutide Based on ongoing clinical trials, survodutide is being studied for several medical conditions: # Obesity and Overweight The primary focus of survodutide research is treating obesity and overweight in adults. Studies are examining its effectiveness in people: – With a BMI of 30 kg/m² or more [4] – With a BMI of 27 kg/m² or more with at least one weight-related health problem [4] – Who are Asian with a BMI of 24 kg/m² or more (as different BMI thresholds apply to Asian populations) [5] # Type 2 Diabetes Survodutide is being studied specifically in people who have both obesity/overweight and type 2 diabetes. Researchers are examining not only its effects on weight loss but also on: – Blood sugar control (HbA1c levels) – Insulin levels – Other diabetes-related parameters [6] # Liver Diseases Several clinical trials are focusing on survodutide’s potential benefits for liver conditions: – Non-alcoholic steatohepatitis (NASH) – a type of liver inflammation and damage caused by a buildup of fat in the liver [7] – Metabolic dysfunction-associated steatohepatitis (MASH) – the newer term for NASH that better reflects its connection to metabolic problems [8] – Liver fibrosis – scarring of liver tissue that can occur with NASH/MASH [8] – Cirrhosis – advanced scarring of the liver [9] These studies are examining whether survodutide can reduce liver fat, improve liver inflammation, and even potentially reverse liver scarring in some cases. # Cardiovascular Health One major study (SYNCHRONIZE™ – CVOT) is specifically examining survodutide’s effects on cardiovascular (heart and blood vessel) health in people with overweight or obesity who also have: – Established cardiovascular disease – Chronic kidney disease – Or at least two weight-related complications or risk factors for cardiovascular disease [10] This study aims to determine whether survodutide affects the risk of serious cardiovascular problems like heart attacks and strokes. How Survodutide is Administered Based on the clinical trials, survodutide is administered as: – A once-weekly injection under the skin (subcutaneous) – With doses that are typically started low and gradually increased (“titrated”) to the target dose [8] – For extended periods – most studies examine treatment periods of 48 weeks (about 1 year) to 76 weeks (about 1.5 years), with some studies lasting up to 4.5 years [9] In the studies, participants also receive counseling on diet and physical activity alongside the medication, suggesting that survodutide is intended to be used as part of a comprehensive weight management approach [2]. Effectiveness of Survodutide While final results from most studies aren’t yet available, the clinical trials are measuring several important outcomes to determine survodutide’s effectiveness: # For Weight Loss: – Percentage change in body weight from baseline – Achievement of specific weight reduction targets (5%, 10%, 15%, or 20% reduction) [2] – Changes in waist circumference and body mass index (BMI) – Changes in body composition (fat mass, lean mass, visceral fat, etc.) # For Diabetes: – Changes in HbA1c (a measure of long-term blood sugar control) – Changes in fasting blood sugar and insulin levels [6] # For Liver Disease: – Reduction in liver fat content – Improvement in liver inflammation – Improvement in liver fibrosis (scarring) – Changes in liver enzymes (ALT, AST) [11] # For Cardiovascular Health: – Major adverse cardiovascular events (heart attacks, strokes, etc.) – Changes in blood pressure – Changes in blood lipids (cholesterol, triglycerides) [10] Potential Side Effects While detailed information about side effects isn’t provided in these clinical trial summaries, the studies are monitoring participants for: – Any unwanted effects during treatment – Effects on the stomach and intestines – Changes in vital signs and laboratory values – Serious adverse events that might require hospitalization [1] The fact that studies are gradually increasing the dose suggests that this approach may help minimize potential side effects. Ongoing Research Survodutide is being studied in multiple Phase III clinical trials, which is typically the final phase of testing before a medication can be submitted for regulatory approval. These studies include: – SYNCHRONIZE™ – CVOT – examining cardiovascular outcomes [10] – LIVERAGE™ studies – focusing on liver diseases including NASH/MASH [8] – Studies in specific populations, including Chinese individuals with overweight or obesity [5] – Studies comparing survodutide to other treatments like semaglutide (Wegovy®) [3] The comprehensive nature of these studies suggests that the developers are examining survodutide’s effects in a wide range of populations and conditions. Who Can Take Survodutide? Since survodutide is still in clinical trials, it’s not yet available for general use. However, the eligibility criteria for the clinical trials provide some insight into who might eventually be able to take this medication if approved: # People generally included in the studies: – Adults (typically 18 years or older) – People with a BMI of 27 kg/m² or higher, or 24 kg/m² or higher for Asian individuals – People with weight-related health complications like type 2 diabetes, high blood pressure, or elevated blood lipids – People who have previously tried to lose weight through lifestyle changes without success [2] ### People generally excluded from the studies: – People with a history of other chronic liver diseases (for liver-focused studies) – People with high alcohol intake (for liver-focused studies) – People with type 2 diabetes (for some studies specifically focused on non-diabetic individuals) [4] This suggests that if approved, survodutide might be indicated for adults with obesity or overweight with weight-related complications, particularly those who have not achieved sufficient weight loss through diet and exercise alone.
Aspect Details
Drug Information Survodutide (also known as BI 456906) is an investigational medication administered as a subcutaneous (under the skin) injection once weekly
Target Conditions • Obesity and overweight
• Non-alcoholic steatohepatitis (NASH)/Metabolic dysfunction-associated steatohepatitis (MASH)
• Type 2 diabetes with obesity
• Liver fibrosis associated with NASH/MASH
Patient Eligibility • Adults 18+ years
• BMI ranging from 24-40 kg/m² depending on the study
• Some studies require at least one weight-related health condition
• Some studies specifically target people with NASH/MASH and liver fibrosis
• Previous unsuccessful attempts at weight loss through diet changes
Trial Designs • Randomized, double-blind, placebo-controlled studies
• Treatment duration ranging from 48 weeks to up to 7 years
• Most studies compare multiple doses of survodutide to placebo
• Participants typically have a 2 in 3 chance of receiving active medication
• All participants receive counseling on diet and exercise
Primary Outcomes • Percentage change in body weight
• Achievement of ≥5%, ≥10%, ≥15% weight reduction
• Improvement in liver histology and fibrosis
• Reduction in liver fat content
• Cardiovascular safety
Secondary Outcomes • Changes in blood pressure
• Changes in HbA1c and other diabetes markers
• Changes in liver enzymes and liver function
• Changes in body composition (fat vs. muscle)
• Changes in cholesterol and triglycerides
• Quality of life measures
Global Studies • Studies being conducted in multiple countries
• Specific trials for Chinese and Japanese populations
• Range of study durations to assess both short and long-term effects

FAQ

  • What is survodutide and how does it work? Survodutide (also known as BI 456906) is an investigational medication administered as a weekly injection under the skin. It's being developed to help people with obesity, overweight, and related conditions like non-alcoholic steatohepatitis (NASH) or diabetes. While the exact mechanism isn't fully detailed in the trial information, it appears to work by affecting how the body processes fat and energy, potentially improving metabolism and promoting weight loss.
  • What conditions is survodutide being studied for? Survodutide is being studied for multiple conditions, including: obesity and overweight; non-alcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH); type 2 diabetes in combination with obesity; liver fibrosis (scarring) related to NASH/MASH; and for cardiovascular safety in people with obesity who have established cardiovascular disease or risk factors.
  • What results have been seen in clinical trials with survodutide? The clinical trial information provided doesn't include final results, as these studies are ongoing. The trials are measuring various outcomes including: percentage of weight loss; improvement in liver fat and liver function; changes in blood pressure and blood sugar levels; improvement in body composition (ratio of fat to muscle); and cardiovascular safety. The studies are designed to determine effective dosing, safety profile, and benefits compared to placebo.
  • How is survodutide administered and for how long? Survodutide is administered as a subcutaneous injection (under the skin) once per week. In the clinical trials, the treatment duration varies widely, from approximately 48 weeks (about 1 year) to up to 7 years for the longest studies. Many trials use a dose escalation approach, starting with lower doses and gradually increasing to target doses to help participants adjust to the medication.
  • Who might be eligible for survodutide treatment in clinical trials? Eligibility varies by study, but typically includes adults (18+ years) with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) plus related health conditions. Some studies specifically target people with NASH/MASH and liver fibrosis, while others focus on people with type 2 diabetes alongside obesity. Most trials require participants to have previously attempted weight loss through diet changes. Specific studies may have additional requirements or exclusions based on medical history.

Ongoing Clinical Trials on SURVODUTIDE

  • A study to evaluate the effect of survodutide on protein levels in the urine for patients with chronic kidney disease

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Germany The Netherlands Spain

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark Finland Germany Greece +5

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Finland Germany The Netherlands Poland Sweden

  • Study on the Effect of Survodutide on Heart Safety in Patients with Obesity and Cardiovascular or Kidney Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Finland +11

  • Study to Evaluate the Effectiveness of Survodutide in Reducing Liver Fat and Weight in Patients with Obesity or Overweight and Non-Alcoholic Steatohepatitis (NASH)

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany The Netherlands Spain

Glossary

  • Survodutide: An investigational medication (also called BI 456906) administered as a weekly subcutaneous injection being studied for treatment of obesity, overweight, and related conditions like NASH and type 2 diabetes.
  • BMI (Body Mass Index): A calculation using height and weight to estimate body fat and categorize weight status. In the trials, BMI thresholds of 24-40 kg/m² are used for eligibility, with ≥30 kg/m² typically considered obesity and 25-30 kg/m² considered overweight.
  • NASH (Non-alcoholic Steatohepatitis): A liver disease characterized by fat accumulation, inflammation, and damage in the liver not caused by alcohol consumption. It's closely related to obesity and metabolic disorders.
  • MASH (Metabolic dysfunction-associated Steatohepatitis): A term increasingly used instead of NASH to better reflect the metabolic origins of the condition. It refers to liver inflammation and damage associated with metabolic disorders.
  • Subcutaneous Injection: Administration of medication under the skin, rather than into a muscle or vein. Survodutide is given via weekly subcutaneous injections in all the clinical trials.
  • Placebo: A substance that looks like the medicine being tested but contains no active ingredient. In survodutide trials, some participants receive placebo injections for comparison to measure the true effect of the medication.
  • Liver Fibrosis: Scarring of liver tissue that occurs in response to injury or inflammation, often categorized in stages (F1-F4, with F4 being cirrhosis). Several survodutide trials focus on patients with stage F1-F3 fibrosis.
  • MRI-PDFF (Magnetic Resonance Imaging-Proton Density Fat Fraction): A specialized MRI technique used to measure fat content in the liver, used in several survodutide trials to assess improvement in liver fat.
  • HbA1c (Glycosylated Hemoglobin): A blood test that shows average blood sugar levels over the past 2-3 months, commonly used to monitor diabetes. Many survodutide trials measure changes in HbA1c as a secondary outcome.
  • Liver Biopsy: A procedure to remove a small sample of liver tissue for examination, used in some survodutide trials to directly assess changes in liver inflammation and fibrosis.
  • Cirrhosis: Advanced scarring (fibrosis) of the liver that represents the most severe stage of liver disease. Some survodutide trials are studying its potential to prevent progression to cirrhosis.
  • MELD Score: Model for End-stage Liver Disease score, a numerical scale used to express severity of liver disease. Some survodutide trials monitor changes in MELD score.
  • CSPH (Clinically Significant Portal Hypertension): Increased blood pressure in the portal vein that carries blood from the digestive organs to the liver, a serious complication of advanced liver disease monitored in some survodutide trials.
  • Pharmacokinetics: The study of how drugs move through the body, including absorption, distribution, metabolism and excretion. Some survodutide trials specifically study these properties.
  • 5P-MACE (5-Point Major Adverse Cardiac Event): A composite endpoint in cardiovascular studies that includes CV death, non-fatal stroke, non-fatal heart attack, ischemia-related coronary revascularization, and heart failure events. Used in survodutide cardiovascular safety trials.

References

  1. https://clinicaltrials.gov/study/NCT06492135
  2. https://clinicaltrials.gov/study/NCT06176365
  3. https://clinicaltrials.gov/study/NCT06745284
  4. https://clinicaltrials.gov/study/NCT06066515
  5. https://clinicaltrials.gov/study/NCT06214741
  6. https://clinicaltrials.gov/study/NCT06066528
  7. https://clinicaltrials.gov/study/NCT06309992
  8. https://clinicaltrials.gov/study/NCT06632444
  9. https://clinicaltrials.gov/study/NCT06632457
  10. https://clinicaltrials.gov/study/NCT06077864
  11. https://clinicaltrials.gov/study/NCT04771273