Clinical trials: NASH With Fibrosis
- Condition NASH With Fibrosis
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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.
Moderate Liver Impairment, Severe Liver Impairment
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment.
- Trial name
- NCT04634149
- Testing
- BMS-986036
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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.
NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
A Study of EDP-297 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
- Trial name
- NCT04559126
- Testing
- EDP-297
- Where
- Netherlands
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
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 With Fibrosis, NAFLD
AGED Diagnostics Liver Disease Assessment
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood.
- Conditions
- NASH With Fibrosis, NAFLD, Healthy
- Trial name
- AGEDDX (NCT06348563)
- Testing
- AGED Multiple Target Assay in Healthy Controls, AGED Multiple Target Assay in NAFLD Participants, AGED Multiple Target Assay in Fibrosis Participants
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Active Genomes Expressed Diagnostics, Corp
Healthy Participants
Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
- Trial name
- NCT05604287
- Testing
- ID119031166M
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
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.
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
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
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
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