Phase 2 N=18 Treating Nonalcoholic Steatohepatitis With Pioglitazone
Hepatitis
Primary: Number of Patients With Improvement in Liver Histology — 12 participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=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
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=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=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 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 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=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…
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=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=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
Phase 2 N=128 A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
NASH - Nonalcoholic Steatohepatitis
Primary: Effect of Efruxifermin (EFX) vs Placebo on Fibrosis Regression in Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)-Associated Stage 2 or 3…
Phase 2 N=17 Spironolactone Therapy In Young Women With NASH
NASH - Nonalcoholic Steatohepatitis
Primary: Change in Liver Stiffness on Magnetic Resonance Elastography (MRE) — 0.025; -0.265; 0.105; 0.135 Change in kPA
Phase 4 N=105 Prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanics With Diabetes Mellitus Type 2 (T2DM) and Role of Treatment
Nonalcoholic Steatohepatitis
Primary: Liver Histology (Kleiner's et al Criteria, Hepatology 2005) — 7; 13; 24 Participants
Phase 2 N=7 A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic Steatohepatitis (NASH)
Primary: Number of Participants With Treatment-related Adverse Events. — 3 Participants
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 3 N=26 Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH
Nonalcoholic Steatohepatitis · Liver Diseases
Primary: The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months. — 19; 7 participants — p=0.46
Phase 2 N=295 A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Non-alcoholic Steatohepatitis (NASH)
Primary: Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3)…
Phase 2 N=97 Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic Steatohepatitis (NASH) · Nonalcoholic Fatty Liver Disease (NAFLD)
Primary: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events — 50; 60; 50; 25 percentage of participants
Phase 2 N=142 Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
Primary: Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline — -11.31; -27.59; 2.52; -28.68 percent change…
N/A N=28 NASH Fitness Intervention in Thrombosis Trial (NASHFit)
Liver Diseases · Blood Disorder · Digestive System Disease
Primary: PAI-1 Level — 151.4; 176.2 ng/mL
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=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=110 A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
NASH - Nonalcoholic Steatohepatitis
Primary: Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 12. — -12.32; -13.44; -14.14; -0.29 Absolute percentage of hepatic fat
Phase 2 N=125 Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Non-alcoholic Steatohepatitis
Primary: Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) — -32.9; -10.4 percent…
Phase 4 N=103 Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
Non-Alcoholic Fatty Liver Disease
Primary: Percentage of Liver Fat — -7.9; -4.6 percentage of liver fat — p=0.48
Phase 2 N=75 A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Non-Alcoholic Steatohepatitis
Primary: Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 — -8.43; -6.45; -1.26; -6.77 percentage — p=0.0004
Phase 2 N=255 Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Nonalcoholic Fatty Liver Disease · Nonalcoholic Steatohepatitis With Liver Fibrosis
Primary: Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by…