In short
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.
Key points
- Survodutide is an experimental medication currently being studied in multiple clinical trials for treating obesity, overweight, and related conditions like non-alcoholic steatohepatitis (NASH) and type 2 diabetes. Administered as a weekly subcutaneous injection, these trials are evaluating different doses of survodutide compared to placebo across diverse patient populations worldwide. The studies primarily measure weight loss effectiveness, improvement in liver function, metabolic parameters, and cardiovascular safety. Treatment durations range from approximately one year to multiple years, with some trials specifically focusing on certain populations like Chinese or Japanese patients. The comprehensive research program suggests survodutide is being positioned as a potential therapeutic option for obesity and its complications.
At a glance
- 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
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 . 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 .
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 . 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
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
- With a BMI of 27 kg/m² or more with at least one weight-related health problem
- Who are Asian with a BMI of 24 kg/m² or more (as different BMI thresholds apply to Asian populations)
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
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
- Metabolic dysfunction-associated steatohepatitis (MASH) - the newer term for NASH that better reflects its connection to metabolic problems
- Liver fibrosis - scarring of liver tissue that can occur with NASH/MASH
- Cirrhosis - advanced scarring of the liver
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
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
- 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
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 .
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)
- 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
For Liver Disease:
- Reduction in liver fat content
- Improvement in liver inflammation
- Improvement in liver fibrosis (scarring)
- Changes in liver enzymes (ALT, AST)
For Cardiovascular Health:
- Major adverse cardiovascular events (heart attacks, strokes, etc.)
- Changes in blood pressure
- Changes in blood lipids (cholesterol, triglycerides)
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
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
- LIVERAGE™ studies - focusing on liver diseases including NASH/MASH
- Studies in specific populations, including Chinese individuals with overweight or obesity
- Studies comparing survodutide to other treatments like semaglutide (Wegovy®)
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
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)
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.