What Is Survodutide?
Survodutide is a medication currently undergoing investigation in clinical trials for various metabolic conditions. It is administered as a subcutaneous injection, typically using a pre-filled syringe for weekly dosing. While the specific mechanism of action is not detailed in the available trial descriptions, survodutide is being studied for its potential to address conditions like obesity, metabolic dysfunction-associated steatohepatitis (MASH), and type 2 diabetes. A total of 15 clinical trials have been initiated for survodutide, with the first trial beginning in 2021 and the latest expected to conclude in 2026. These studies have collectively enrolled 11,902 participants to date. The development of survodutide is primarily sponsored by Boehringer Ingelheim, an industry sponsor, with one trial also involving the University Medical Center Groningen.
Uses and Conditions Under Study
Survodutide is being investigated across a range of conditions, primarily focusing on metabolic health. The most significant area of study is in obesity and overweight, with 13 trials exploring survodutide's potential to help participants manage their weight. These conditions are characterized by excessive body fat, which can lead to various health problems. Survodutide aims to provide a therapeutic option for individuals seeking to achieve and maintain weight loss.
Another key area of research involves liver conditions, specifically Metabolic Dysfunction Associated Steatohepatitis (MASH) and Non-alcoholic Steatohepatitis (NASH). MASH, formerly known as NASH, is a severe form of fatty liver disease that can lead to inflammation and liver damage. Survodutide is being studied in 3 trials for these conditions, suggesting a potential role in improving liver health for affected individuals.
Beyond weight management and liver disease, survodutide is also being explored for its effects in other metabolic disorders. One trial is investigating its use in Type 2 Diabetes Mellitus, a chronic condition where the body either doesn't produce enough insulin or can't effectively use the insulin it produces. Additionally, survodutide is being studied in 1 trial for Chronic Kidney Disease and 1 trial for Liver Fibrosis, which is the scarring of the liver often associated with conditions like MASH. Two trials also involve healthy volunteers, likely to assess the drug's safety, pharmacokinetics, and how it is processed by the body.
Dosing
Survodutide is administered as a subcutaneous injection, typically using a pre-filled syringe. The drug is designed for once-weekly dosing. Clinical trials have explored a variety of strengths to determine the most effective and well-tolerated doses for different conditions.
The strengths of survodutide that have been studied include:
- 0.3 mg
- 0.6 mg
- 1.2 mg
- 2.4 mg
- 3.6 mg
- 4.8 mg
- 6.0 mg
These dosages are being investigated across the various conditions under study, such as obesity, overweight, and metabolic dysfunction-associated steatohepatitis. Some trial arms have also explored specific planned maintenance treatments at 2.4 mg, 4.8 mg, or 6.0 mg. Additionally, trials have investigated different formulations, including "Survodutide formulation A" and "Survodutide formulation B2," to optimize the drug's delivery or composition. The available trial data does not specify separate pediatric doses, focusing on adult participants.
Side Effects
In a clinical trial involving 214 patients taking Survodutide, the most common side effects were primarily gastrointestinal. These events were generally reported more frequently in patients receiving Survodutide compared to those on placebo.
- Nausea was reported by 65.0% of patients taking Survodutide, compared to 27.8% on placebo.
- Diarrhea occurred in 48.6% of patients on Survodutide, while 25.3% of patients on placebo experienced it.
- Vomiting affected 40.2% of patients taking Survodutide, compared to 7.6% on placebo.
- Constipation was experienced by 20.1% of patients on Survodutide, versus 17.7% on placebo.
- Headache was reported by 18.2% of patients taking Survodutide, compared to 16.5% on placebo.
- Decreased appetite occurred in 17.3% of patients on Survodutide, while 10.1% of patients on placebo experienced it.
- Fatigue affected 16.8% of patients taking Survodutide, compared to 8.9% on placebo.
- Abdominal distension was experienced by 15.9% of patients on Survodutide, versus 8.9% on placebo.
Clinical Trial Results
Clinical trials have investigated the efficacy of Survodutide in adults with non-alcoholic steatohepatitis (NASH) and fibrosis (F1-F3).
In a 48-week study (NCT04771273), Survodutide demonstrated significant improvements in several key markers of liver health compared to placebo:
- Reduction in NAS Score: The NAS (NASH Activity Score) is a measure of disease activity, with lower scores indicating less inflammation and damage. Patients receiving Survodutide 6.0 mg experienced an average reduction of 3.3 units from baseline, compared to a 0.4-unit reduction in the placebo group.
- Reduction in Liver Fat Content: Liver fat content, assessed by MRI-PDFF, was substantially reduced. Patients on Survodutide 6.0 mg saw an average absolute reduction of 12.96 percentage points in liver fat, while the placebo group had a 1.89 percentage point reduction. Furthermore, 76.9% of patients on Survodutide 6.0 mg achieved at least a 30% relative reduction in liver fat content from baseline, compared to 16.5% on placebo.
- Improvement in NASH Histology: A key outcome was the improvement in liver histological findings based on biopsy, indicating a resolution of the underlying liver inflammation and damage. 63.8% of patients on Survodutide 4.8 mg showed this improvement in NASH histology, compared to 15.2% on placebo.
- Improvement in Liver Fibrosis: Survodutide also led to improvements in liver fibrosis, meaning a decrease in the severity of liver scarring. 44.2% of patients on Survodutide 6.0 mg experienced at least a one-stage decrease in fibrosis severity, compared to 21.5% on placebo.
These results indicate that Survodutide can significantly reduce liver fat, improve NASH disease activity, and lead to a decrease in liver fibrosis in patients with NASH.
Currently Recruiting Trials
Survodutide is currently being investigated in several clinical trials, focusing on its potential to help individuals living with liver diseases such as Metabolic Dysfunction Associated Steatohepatitis (MASH), also known as Non-Alcoholic Steatohepatitis (NASH). These studies aim to understand how Survodutide might improve liver health in different patient populations.
One significant study, known as LIVERAGE™ - Cirrhosis (NCT06632457), is a Phase 3 trial sponsored by Boehringer Ingelheim. This study is designed to test whether Survodutide can help people who have NASH/MASH and have already developed cirrhosis, a more advanced stage of liver disease. Researchers are seeking to enroll approximately 1,590 adult participants, aged 18 years or older, who have a confirmed diagnosis of NASH or MASH and a Body Mass Index (BMI) of 27 kg/m2 or more (or 25 kg/m2 or more if the participant is Asian).
Another ongoing Phase 3 trial, LIVERAGE™ (NCT06632444), also sponsored by Boehringer Ingelheim, is exploring Survodutide's effects in people with NASH/MASH who have moderate or advanced liver fibrosis. This study is open to adults, 18 years or older, living with obesity who have a confirmed diagnosis of NASH/MASH and moderate or advanced liver fibrosis. The trial aims to recruit around 1,800 participants to evaluate the drug's effectiveness in this specific population.
Where to Participate
Clinical trials for Survodutide are actively recruiting across a wide geographic area, making participation accessible to many individuals. These studies are currently being conducted at 161 sites located in 132 cities across 30 states.
Some of the top locations with multiple participating sites include:
- Miami, Florida (13 sites)
- San Antonio, Texas (9 sites)
- Austin, Texas (8 sites)
- Orlando, Florida (7 sites)
- Houston, Texas (7 sites)
- Dallas, Texas (7 sites)
- Las Vegas, Nevada (6 sites)
- Tucson, Arizona (6 sites)
- Poway, California (4 sites)
- Waco, Texas (4 sites)
Eligibility for these trials generally requires participants to be adults, specifically between 18 and 18 years of age. All genders are welcome to participate. These studies are not open to healthy volunteers or children, as they focus on individuals with specific medical conditions.
Development Timeline
The journey of Survodutide in clinical development began on February 25, 2021, with its first clinical trial. Since then, the development program has steadily expanded, primarily driven by Boehringer Ingelheim, which has sponsored 14 of the 15 total trials. One additional trial has been sponsored by the University Medical Center Groningen.
Initially, Survodutide was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the research pipeline broadened significantly to investigate its potential across a wider range of conditions. This expansion included studies in healthy volunteers, and then progressed to focus on Metabolic Dysfunction Associated Steatohepatitis (MASH), Chronic Kidney Disease, Non-alcoholic Steatohepatitis (NASH), Type 2 Diabetes Mellitus, and Liver Fibrosis.
The clinical program has advanced through various phases, starting with 5 Phase 1 trials to assess safety and dosage. This was followed by 2 Phase 2 trials to further evaluate effectiveness and side effects. Currently, Survodutide is undergoing extensive investigation in 8 Phase 3 trials, which are large-scale studies designed to confirm efficacy and monitor adverse reactions in diverse populations. The latest projected completion date for a Survodutide trial is February 17, 2026, marking a continued commitment to understanding its full therapeutic potential.