Phase 2 N=18 Treating Nonalcoholic Steatohepatitis With Pioglitazone
Hepatitis
Primary: Number of Patients With Improvement in Liver Histology — 12 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=13 A Preliminary Study to Evaluate Cysteamine Therapy in Human Subjects With Non-Alcoholic Steatohepatitis (NASH)
Fatty Liver
Primary: Normalization or >50% of Serum ALT Levels From Baseline — 7 participants
Phase 2 N=53 Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver Disease (NAFLD)
Primary: Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6…
Phase 2 N=80 Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
Nonalcoholic Fatty Liver · Nonalcoholic Steatohepatitis
Primary: Absolute Change in Intrahepatic Lipid Content, by 1H-MRS — -6.6; 3.6 Mean absolute percentage change
N/A N=51 Obesity and Nonalcoholic Fatty Liver Disease
Non-alcoholic Fatty Liver Disease
Primary: Hepatic Insulin Sensitivity Index (HISI) — 0.8; 1.4 [10000/(μmol/min)x(mU/L)] — p=<0.019
Phase 2 N=44 Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis
Non Alcoholic Steatohepatitis · Fibrosis
Primary: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 — 9; 4 Participants
Phase 2 N=9 Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
Fatty Liver Disease, Nonalcoholic
Primary: Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months — 5 units on a scale — p=0.015
Phase 4 N=101 University of Texas H.S.C. San Antonio Pioglitazone in Non-Alcoholic Steatohepatitis Trial (UTHSCSA NASH Trial)
Nonalcoholic Steatohepatitis · Nonalcoholic Fatty Liver Disease · Type 2 Diabetes Mellitus
Primary: Liver Histology (Using Kleiner et al Criteria, Hepatology 2005) — 9; 29 Participants
Phase 2 N=155 A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
Hepatic Cirrhosis · Liver Fibrosis · Nonalcoholic Fatty Liver Disease (NAFLD)
Primary: The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 — 28.2; 24.3; 28.2…
Phase 2 N=197 A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
Liver Fibrosis · Nonalcoholic Fatty Liver Disease (NAFLD) · Nonalcoholic Steatohepatitis
Primary: The Percentage of Participants With Improvement in Fibrosis or Nonalcoholic Steatohepatitis (NASH) at Week 24 — 30.6; 24.0; 26.5; 14.3 Percentage of Participants — p=0.055
Phase 2 N=275 Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Non-Alcoholic Steatohepatitis (NASH)
Primary: Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) — 21…
Phase 2 N=55 Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis
Primary: Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. — -1.6; -0.1 NAS score units
N/A N=14 Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery
NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease
Primary: Percent Change in Liver Fat Between Baseline and 12 Weeks Post-surgery — -16.4 percent change
Phase 2 N=132 A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
Non-Alcoholic Steatohepatitis
Primary: Mean Change From Baseline (Average) in Alanine Aminotransferase (ALT) at Week 12 — -13.85; -23.76; -26.14 units per liter (U/L) — p=0.0495
Phase 2 N=247 Phase 2b Study in NASH to Assess IVA337
Non-Alcoholic Steatohepatitis (NASH)
Primary: SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F) — 41; 34; 22; 42 Participants — p==0.061
Phase 2 N=50 Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis
Non Alcoholic Steatohepatitis
Primary: Change in Liver Fat as Measured by MRI-PDFF — 15.0; 18.5; 11.6; 16.4 percentage of total fat
Phase 3 N=247 Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Liver Diseases
Primary: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and…
Phase 2 N=26 Treating Nonalcoholic Steatohepatitis (NASH) With Metformin
Hepatitis
Primary: Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category) — 9; 11; 5; 1 participants — p=<0.001
Phase 2 N=164 A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
Non-alcoholic Steatohepatitis
Primary: Percent Change From Baseline in Whole Liver Fat at Week 16 — -3.21; -16.12; -4.36 Percent change — p=0.0696
Phase 2 N=65 JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis
Primary: Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population) — 0.38; -0.44; -3.09 percentage of fat — p=0.034
Phase 2 N=82 Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic Steatohepatitis (NASH)
Primary: Change in Absolute Liver Fat Content (Part 1) — -9.68; -11.91; -0.85 percent of liver fat — p=<0.001
Phase 2 N=40 Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
Non-alcoholic Fatty Liver Disease
Primary: Liver Fat Content — 8.38; 7.72; 8.50; 7.29 percentage of liver fat content — p=0.94
N/A N=4 Metabolomic Analysis of Hepatic Insulin Resistance
Type 2 Diabetes · Obesity
Primary: Insulin Sensitivity — 8 m value — p=<0.05
Phase 2 N=12 The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
NAFLD · Nonalcoholic Fatty Liver · NASH - Nonalcoholic Steatohepatitis
Primary: Intrahepatic Lipid Content (IHL, Percent Liver Fat) — 3.9 absolute change in percentage liver fat — p=0.4
Phase 2 N=280 A Phase 2b Study of Icosabutate in Fatty Liver Disease
Non Alcoholic Steatohepatitis (NASH)
Primary: Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis…
Phase 2 N=99 A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
Non-Alcoholic Fatty Liver Disease (NAFLD)
Primary: Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 — 8.14; -40.01; -30.14; -40.13 percent change — p=0.0000
Phase 2 N=75 Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Nonalcoholic Steatohepatitis · Nonalcoholic Fatty Liver Disease
Primary: Percent Change From Baseline (CFB) in Percent (%) Liver Fat as Assessed Via Magnetic Resonance Imaging Using Proton Density Fat Fraction Acquisition (MRI-PDFF) at Week 6…
N/A N=70 Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver Disease · Non-alcoholic Steatohepatitis
Primary: Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score — -13.0; 8.7 percent change
Phase 2 N=6 A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
Fatty Liver
Primary: Number of Study Participants With Adverse Events — 0; 0 Participants
Phase 2 N=117 Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
NASH - Nonalcoholic Steatohepatitis
Primary: Relative Change From Baseline to Week 36 in the Percentage of Liver Fat Content (LFC) (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF])…