Survodutide for Obesity and Fatty Liver Disease
Trial Summary
What is the purpose of this trial?
This study is open to adults who are at least 18 years old and have * presumed or confirmed NASH together with overweight or obesity and * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² and at least one weight-related health problem. People with a history of other chronic liver diseases cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are taking medications associated with liver injury, hepatic steatosis, or steatohepatitis.
What data supports the idea that Survodutide for Obesity and Fatty Liver Disease is an effective treatment?
The available research does not provide specific data on Survodutide for Obesity and Fatty Liver Disease. However, it mentions other treatments like cotadutide, which showed improvements in liver fat and metabolic health in people with obesity and type 2 diabetes. This suggests that similar drugs targeting the same pathways might be effective. Without direct data on Survodutide, we can't confirm its effectiveness, but the success of similar treatments offers some hope.12345
What safety data is available for Survodutide (BI 456906) in treating obesity and fatty liver disease?
The provided research does not contain specific safety data for Survodutide (BI 456906) or its other names. The studies mentioned focus on other treatments like DA-3091, liraglutide, saroglitazar, and cotadutide, which are not directly related to Survodutide. Therefore, no relevant safety data for Survodutide is available in the given research.45678
Is Survodutide a promising drug for obesity and fatty liver disease?
Yes, Survodutide is a promising drug for obesity and fatty liver disease because it is similar to other treatments that have shown positive effects in reducing liver fat and improving liver health. These treatments also help with weight loss and managing diabetes, which are important for treating these conditions.2691011
Research Team
Eligibility Criteria
Adults over 18 with obesity or overweight and presumed or confirmed NASH can join. They must have a BMI of at least 30, or a BMI of 27 plus a weight-related health issue like hypertension, type 2 diabetes, dyslipidemia, sleep apnea, or cardiovascular disease. Those with other chronic liver diseases are excluded.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Survodutide (Peptide)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor