Clinical trials: Non-Alcoholic Steatohepatitis
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Diabetes Mellitus, Type 2, Hypertriglyceridemia
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
The design of the Phase 2 clinical trial includes the following elements: Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs.
- Conditions
- Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease
- Trial name
- NCT05464784
- Testing
- MN-001
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MediciNova
NASH - Nonalcoholic Steatohepatitis
Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
- Trial name
- HM-TRIA-201 (NCT04505436)
- Testing
- HM15211
- Where
- 60 sites in United States, South Korea
- Volunteers
- 215 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study in Participants With Non-cirrhotic NASH With Fibrosis
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and…
- Trial name
- COSMOS (NCT05638737)
- Testing
- AZD4831
- Where
- 65 sites in United States, Argentina and 7 more
- Volunteers
- 112 people
- Sponsor
- AstraZeneca
Non-Alcoholic Fatty Liver Disease
A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.
- Trial name
- NCT03350165
- Testing
- K-877
- Where
- 16 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Kowa Company, Ltd.
Nonalcoholic Steatohepatitis (NASH)
A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
- Trial name
- NCT05320146
- Testing
- MRI-PDFF
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Corcept Therapeutics
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- Trial name
- NCT06037577
- Testing
- CM-101
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- ChemomAb Ltd.
Nonalcoholic Fatty Liver, Weight Loss
Study on GS300 on NAFLD
To determine the efficacy of GS300 when administered for 24 weeks in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
- Trial name
- REVERT (NCT04887766)
- Testing
- GS300
- Volunteers
- 250 people
- Sponsor
- Gelesis, Inc.
NAFLD, Liver Fibrosis
Different Doses of ZED1227 vs. Placebo in NAFLD
This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will…
- Trial name
- NormaliZED (NCT05305599)
- Testing
- ZED1227
- Where
- Germany
- Volunteers
- 186 people
- Sponsor
- Dr. Falk Pharma GmbH
Fibrosis, Inflammation
A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RXC007.
- Conditions
- Fibrosis, Inflammation, Idiopathic Pulmonary Fibrosis, Non-alcoholic Steatohepatitis
- Trial name
- NCT04931147
- Testing
- RXC007
- Where
- United Kingdom
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Redx Pharma Ltd
Metabolic Dysfunction-Associated Steatotic Liver Disease
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease…
- Trial name
- NCT07165028
- Testing
- Tirzepatide, Retatrutide
- Where
- 563 sites in United States, Argentina and 32 more
- Volunteers
- 4,500 people
- Sponsor
- Eli Lilly and Company
Nonalcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver Disease
Phase 2b Study of GSK4532990 in Adults With NASH
The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4).
- Trial name
- HORIZON (NCT05583344)
- Testing
- GSK4532990
- Where
- 170 sites in United States, Argentina and 15 more
- Volunteers
- 284 people
- Sponsor
- GlaxoSmithKline
Nonalcoholic Steatohepatitis
Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers
Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period. Period: 24 hours post dose in each period. Each subject will complete two study periods.
- Trial name
- NCT05983328
- Testing
- HUYPS-1 one tablet, HUYPS-1 nine tablets
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sinew Pharma Inc.
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection.
- Trial name
- NCT06842563
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Singlera Genomics Inc.
Non-alcoholic Fatty Liver Disease
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
- Trial name
- ZENITH-2 (NCT07221188)
- Testing
- Efimosfermin Alfa
- Where
- 66 sites in United States, Australia and 6 more
- Volunteers
- 1,250 people
- Sponsor
- GlaxoSmithKline
Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis
- Trial name
- NCT04607655
- Testing
- GB1211
- Sponsor
- Galecto Biotech AB
NASH
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high…
- Trial name
- NCT04048135
- Testing
- Pegozafermin
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 101 people
- Sponsor
- 89bio, Inc.
Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Non-alcoholic fatty liver disease (NAFLD) treatment drug HEC96719 in Healthy Male and Female Subjects
- Trial name
- NCT04422496
- Testing
- HEC96719
- Where
- Australia
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
NASH - Nonalcoholic Steatohepatitis
Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human…
- Trial name
- NCT03213145
- Testing
- intraconazole, Rifampin, EDP 305
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc