Clinical trials: NASH With Fibrosis
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Hepatic Cirrhosis, Nonalcoholic Steatohepatitis
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and…
- Trial name
- NCT00856869
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Norgine
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated…
- Trial name
- NCT06920043
- Testing
- Efimosfermin
- Where
- 30 sites in United States
- Volunteers
- 42 people
- Sponsor
- GlaxoSmithKline
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic…
- Trial name
- LYNX (NCT07270601)
- Testing
- Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- ContextVision AB
NASH - Nonalcoholic Steatohepatitis
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
- Trial name
- NATiV3 (NCT04849728)
- Testing
- IVA337
- Where
- 459 sites in United States, Argentina and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Inventiva Pharma
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.
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
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
Healthy Volunteers, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug…
- Trial name
- NCT05648214
- Testing
- ALN-PNP
- Where
- 6 sites in United States
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
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
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital…
- Trial name
- DPAILO-1 (NCT06344364)
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- 3 sites in Hong Kong, Spain
- Volunteers
- 1,241 people
- Sponsor
- PharmaNest, Inc
Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
- Trial name
- PROXYMO-ADV (NCT05364931)
- Testing
- Cotadutide
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Hepatic Impairment
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function
- Trial name
- NCT04469920
- Testing
- Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg
- Where
- 2 sites in United States
- Volunteers
- 98 people
- Sponsor
- Zydus Therapeutics Inc.
Nonalcoholic Steatohepatitis
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.
- Trial name
- CENTAUR (NCT02217475)
- Testing
- Cenicriviroc
- Where
- 91 sites in United States, Australia and 8 more
- Volunteers
- 289 people
- Sponsor
- Tobira Therapeutics, Inc.
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
- Trial name
- STELLAR-3 (NCT03053050)
- Testing
- SEL
- Where
- 298 sites in United States, Argentina and 25 more
- Volunteers
- 808 people
- Sponsor
- Gilead Sciences
Steatohepatitis
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.
The purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a…
- Trial name
- NCT05864391
- Testing
- AZD7503
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
This study is open to adults who are at least 18 years old living with obesity and have: a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and moderate or advanced…
- Trial name
- NCT06632444
- Testing
- Survodutide
- Where
- 531 sites in United States, Argentina and 34 more
- Volunteers
- 1,800 people
- Sponsor
- Boehringer Ingelheim
Non-Alcoholic Steatohepatitis (NASH)
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages…
- Trial name
- NCT02466516
- Testing
- SEL, SIM
- Where
- 28 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic…
- Trial name
- RESOLVE-IT (NCT02704403)
- Testing
- Elafibranor
- Where
- 326 sites in United States, Argentina and 23 more
- Volunteers
- 2,157 people
- Sponsor
- Genfit