A Study of INI-822 in Healthy Volunteers and Participants With Non-alcoholic Steatohepatitis (NASH)...
Non-alcoholic SteatohepatitisThis Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A and B and in participants with a history of NASH or presumed NASH in Part C.
Phase Ib/II Study to Evaluate the Efficacy and Safety of GH509 Versus Placebo in Patients With NASH/NAFLD...
NASHNAFLDThis is a Phase Ib/II, randomized, double-blind, placebo-controlled, international multi-center clinical study to investigate the efficacy and safety of GH509 in subjects with NASH/NAFLD
Dapagliflozin Efficacy and Action in NASH
Nonalcoholic SteatohepatitisThis is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis...
NASH - Nonalcoholic SteatohepatitisParticipants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if the investigators can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate the safety of VSG. The investigators wish to also understand which of these two interventions is more effective in achieving, 12 months after entry into the trial, a reduction in NAS composed of the non-weighted scores: (1) steatosis 0-3 (2) Inflammation 0-3 and (3) ballooning 0-2. Secondary goals include comparing the two treatment groups for changes in other measured outcomes including MRI assessments of intrahepatic triglyceride and liver elasticity and serum markers. As a pilot study, a sample size of 20 in each group should offer significant information as to the difference in NAS score reduction between to two groups and achieve adequate power to distinguish clinically significant changes in the primary and secondary outcome measures. These data support the overarching objective i.e. to provide evidence that a larger, longer-term clinical outcomes trial is feasible. A goal is for a longer term follow up for 5 years to assess the durability of treatment effects and treatment differences.
Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty...
Metabolic Associated Fatty Liver DiseaseThis randomized, controlled, double-blind study evaluates the utility of alpha-lipoic acid and silybum marianum , versus placebo, in the treatment of metabolic associated fatty liver disease.
Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT...
Non-Alcoholic Steatohepatitis (NASH)Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.
Diet, Immunometabolism and Non-alcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver DiseaseLiver Fat2 moreThis study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16 hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults with non-alcoholic fatty liver disease (NAFLD).
SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver DiseaseNAFLD1 moreThis study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension...
NASH - Nonalcoholic SteatohepatitisThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement...
NASH - Nonalcoholic SteatohepatitisThe aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.