Barra

Researchers are evaluating the effects of survodutide in adults aged 18 years and older who have a confirmed liver condition called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH). Eligible participants must have a body mass index (BMI) of 27 kg/m2 or higher, or at least 25 kg/m2 if they are Asian. The study excludes those with other chronic liver diseases or a history of significant alcohol use. The main goal is to see if survodutide can improve liver function and delay progression of liver damage over time. Participants are randomly assigned to receive either survodutide or a placebo, with twice the chance of receiving survodutide. Both treatments are given as weekly injections under the skin using a pre-filled syringe. Alongside treatment, all participants receive regular counseling to encourage healthy diet and exercise habits. The study lasts up to four and a half years, with frequent visits or remote video calls during the first year and five months, then quarterly visits thereafter. During the study, doctors monitor participants' health, including body weight and liver function using imaging tests at certain visits. Participants complete symptom questionnaires to help assess their condition. Researchers track outcomes such as survival, need for liver transplant, worsening liver disease, and liver-related complications. Safety and any side effects are closely watched throughout the study period to understand the treatment's impact.

Researchers are evaluating the effects of survodutide on adults living with obesity who have a liver disease called non-alcoholic steatohepatitis (NASH) or metabolic associated steatohepatitis (MASH), along with moderate or advanced liver fibrosis. The study focuses on whether survodutide can improve liver function and reduce liver damage in these participants. This Phase III trial aims to assess both the effectiveness and safety of survodutide over a long-term period. Participants are randomly assigned to one of two groups: one receiving weekly injections of survodutide and the other receiving placebo injections that look like the medicine but contain no active drug. The doses of survodutide are gradually increased until the target dose is reached. All participants receive counseling to support healthy diet changes and regular exercise throughout the study. The study lasts up to 7 years, with frequent visits to the study site or remote video calls. In the first year, visits occur every 2 weeks, then every 4 to 6 weeks, and later every 3 months alternating between in-person and remote. Throughout the study, researchers monitor participants' health, liver condition through imaging and biopsies, body weight, digestive system effects, and questionnaires about symptoms and quality of life. The main outcomes include liver fibrosis improvement, resolution of MASH without worsening fibrosis, and long-term safety and efficacy measures.