This trial is evaluating whether Semaglutide 3 mg/mL will improve 1 primary outcome and 24 secondary outcomes in patients with Nonalcoholic Steatohepatitis. Measurement will happen over the course of From baseline (week 0) to week 52.
This trial requires 672 total participants across 10 different treatment groups
This trial involves 10 different treatments. Semaglutide 3 Mg/mL is the primary treatment being studied. Participants will be divided into 5 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
"Some signs of NASH include weight loss, swelling of the abdomen, feeling of fullness after eating meals, and a metallic taste in the mouth or throat and diarrhea. Patients who have signs of steatosis, but have no signs of NASH require further evaluation for the condition." - Anonymous Online Contributor
"In most patients with histological criteria of histologically proven NASH, the cause is most probably dietary, especially fat accumulation within the liver due to obesity of childhood or adolescence." - Anonymous Online Contributor
"nonalcoholic steatohepatitis is a condition characterized by both insulin resistance and fatty liver disease. NASH is typically diagnosed in middle-aged women with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) or diabetes associated with metabolic syndrome." - Anonymous Online Contributor
"2.6% of people are affected with NAFLD. In the United States, 10 million people will have NAFLD by 2030, a 5% increase relative to the present. This is an increase of 7 million new cases, or a 25% increase in the prevalence over the next 20 years." - Anonymous Online Contributor
"Although patients with NASH might in some cases have symptom resolution to diet and activity levels, others never fully recover and most still have disabling comorbidities. Future work is needed to determine whether pharmacologic therapies can modify histologic features and improve outcomes." - Anonymous Online Contributor
"NASH is commonly diagnosed using imaging and laboratory testing. Treatment is often tailored according to the underlying cause, which may include medications, lifestyle modifications, liver transplantation, and various medical procedures. The American Association for the Study of Liver Disease guidelines have recently changed from a focus on the diagnosis criteria in patients with diabetes to a multidisciplinary approach focused on disease severity, fibrosis progression, and the risk of severe complications." - Anonymous Online Contributor
"Semaglutide provided statistically significant improvements on key efficacy parameters in subgroup analysis for improvement in hepatic steatosis and the presence of NASH in patients treated with a dose of semaglutide 3 and 20 mg/ml in both sexes. Recent findings support the safety and efficacy of semaglutide in patients with type II diabetes and hepatic steatosis/ NASH." - Anonymous Online Contributor
"Hepatocellular carcinoma continues to be a great problem in patients with NASH. There are no new treatment options in NASH that are widely accepted as standard of care, but some agents may be potential candidates for clinical trials." - Anonymous Online Contributor
"For NAFLD patients under the age of 50 years, the current study confirms the superiority of semaglutide 3 mg/ml versus placebo over 8 weeks of treatment, regardless of concurrent metabolic treatment or pre-treatment BMI. While BMI and BMI change independently predicted the response to treatment with semaglutide, baseline LDL in children, and baseline ALT in both sexes may serve as indicators of response that are independent of BMI or BMI change." - Anonymous Online Contributor
"At least one-quarter of patients receiving semaglutide experienced AEs in this study, and a higher proportion of patients experienced AEs while taking the drug in the longer-term. The most common AEs were (non-serious, excluding those reported with drug use and those that were in the placebo group in this study): constipation (12.6%), abdominal pain (11.3%), hypoglycaemia (10.7%), headache (10.3%), diarrhoea (9.4%) and nausea (8.6%). Patients receiving semaglutide had a more than 2-fold increased risk of diarrhoea compared to matched controls on placebo (1.67; 95% CI 1." - Anonymous Online Contributor
"About one in every 11 adults in the United States have nonalcoholic steatohepatitis. Nonalcoholic steatohepatitis is usually diagnosed when someone has symptoms such as steatosis, elevated aminotransferase levels, and normal to slightly elevated serum bilirubin. The average age at which a person with nonalcoholic steatohepatitis gets diagnosed is around 40 years old. Women are diagnosed a little earlier than men." - Anonymous Online Contributor
"Genetic factors play an important role in the development of the metabolic syndrome and its components, particularly lipid disorders. Findings from a recent study herein suggest that this entity may be under a genetic control (or in the first rank and with probable major epistatic effect) and suggest the use of the family study methodology in the assessment of their contribution." - Anonymous Online Contributor