Clinical trials: NASH
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Non-Alcoholic Fatty Liver Disease
Ultrasound Liver Fat Quantification on Pediatric Patients
This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI…
- Trial name
- NCT06095479
- Testing
- 2D ultrasound scan and MRI examination
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Philips (China) Investment CO., LTD
NASH - Nonalcoholic Steatohepatitis
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.
- Trial name
- NCT05022693
- Testing
- BIO89-100
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- 89bio, Inc.
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver
Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis
This study is a Phase 1, first-in-human single-dose escalation and multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.
- Trial name
- NCT05680233
- Testing
- OA-235i (4 mg), OA-235i (8 mg), OA-235i (16 mg)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Oasis Pharmaceuticals, LLC
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Evaluating the Pharmacokinetics and Safety of Miricorilant
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT07553663
- Testing
- Miricorilant
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Corcept Therapeutics
NASH - Nonalcoholic Steatohepatitis
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NCT04685993
- Testing
- LPCN 1144
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lipocine Inc.
NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
- Trial name
- NCT06528314
- Testing
- Efruxifermin
- Where
- 345 sites in United States, Argentina and 19 more
- Volunteers
- 2,150 people
- Sponsor
- Akero Therapeutics, Inc
Obesity, Non-Alcoholic SteatoHepatitis (NASH)
A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD)
This study is open to adults who are at least 18 years old and have presumed or confirmed NASH together with overweight or obesity and a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² and at least one…
- Trial name
- NCT06309992
- Testing
- Survodutide
- Where
- 37 sites in United States, Spain
- Volunteers
- 218 people
- Sponsor
- Boehringer Ingelheim
Nonalcoholic Steatohepatitis (NASH)
The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects
This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in healthy subjects.This study is the healthy adult subjects single ascending-dose research
- Trial name
- NCT04194242
- Testing
- HEC96719 tablets
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
NASH With Fibrosis
A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3
This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs…
- Trial name
- ALTITUDE (NCT05461105)
- Testing
- rencofilstat, 75 mg, rencofilstat, 150mg, rencofilstat, 225 mg
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- Hepion Pharmaceuticals, Inc.
NAFLD, NASH
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or NASH (nonalcoholic steatohepatitis)
- Trial name
- NCT04006145
- Testing
- Elobixibat
- Where
- 10 sites in United States
- Volunteers
- 47 people
- Sponsor
- Albireo
Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Study in Healthy Adults Evaluating PF-07202954
The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
- Trial name
- NCT04857437
- Testing
- PF-07202954 Repeat Dose, PF-07202954 Single Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non-alcholic Fatty Liver Disease
Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition.
- Trial name
- NCT02068339
- Testing
- Oltipraz 1 (90mg), Oltipraz 2 (120mg)
- Where
- 5 sites in South Korea
- Volunteers
- 283 people
- Sponsor
- PharmaKing
Non-Alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)
To build a registry of diabetic volunteers by inviting them to get a LiverMultiScan and collecting their contact information to seek interest in participating in future research studies.
- Trial name
- NCT04336800
- Testing
- LiverMultiscan
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Perspectum
Liver Inflammation, Fatty Liver Disease
LivQ-box® Parameters in the Diagnosis of Liver Inflammation
To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.
- Trial name
- NCT06802731
- Where
- China
- Volunteers
- 365 people
- Sponsor
- Wuxi Hisky Medical Technology Co Ltd
Non-Alcoholic Steatohepatitis (NASH), Type2 Diabetes Mellitus
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes.
- Trial name
- NCT02653300
- Testing
- Oral Insulin
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Oramed, Ltd.
NASH - Nonalcoholic Steatohepatitis
A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period.
- Trial name
- VOYAGE (NCT04173065)
- Testing
- VK2809
- Where
- 79 sites in United States, Belgium and 3 more
- Volunteers
- 248 people
- Sponsor
- Viking Therapeutics, Inc.
NASH, Cirrhosis, Liver
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical…
- Trial name
- NCT05500222
- Testing
- Resmetirom
- Where
- 141 sites in United States, Belgium and 7 more
- Volunteers
- 845 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Healthy, NAFLD
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of…
- Trial name
- NCT04845646
- Testing
- ASC41, Itraconazole, Phenytoin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gannex Pharma Co., Ltd.
NASH - Nonalcoholic Steatohepatitis
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
- Trial name
- NCT04897594
- Testing
- TERN-201
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)