Clinical trials: Non Alcoholic Fatty Liver
Non-alcoholic Fatty Liver Disease
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment.
- Trial name
- NCT03681457
- Testing
- LJN452
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Non-alcoholic Fatty Liver Disease in Women With PCOS
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
- Trial name
- NCT03617263
- Testing
- Saroglitazar Magnesium 4 mg Tablet
- Where
- 19 sites in United States, Mexico
- Volunteers
- 60 people
- Sponsor
- Zydus Therapeutics Inc.
Non-alcoholic Steatohepatitis
Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males
1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men. 2.
- Trial name
- NCT06308861
- Testing
- Single administration Amg dose Group, Single administration Bmg dose Group, Single administration Cmg dose Group
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- J2H Biotech
NAFLD, NASH - Nonalcoholic Steatohepatitis
Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test
Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay to diagnose NAFLD by collecting blood sample from healthy…
- Trial name
- NCT05108415
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study
This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease…
- Trial name
- LFQ (NCT04657523)
- Testing
- Investigational Liver Fat Quantification Software
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Non Alcoholic Steatohepatitis (NASH)
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult…
- Trial name
- ELIVATE (NCT04065841)
- Testing
- Tropifexor, Licogliflozin
- Where
- 80 sites in United States, Argentina and 22 more
- Volunteers
- 234 people
- Sponsor
- Novartis Pharmaceuticals
NASH - Nonalcoholic Steatohepatitis
Ascending Dose Study of HU6 in Healthy Volunteers
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next…
- Trial name
- NCT04463017
- Testing
- HU6
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Rivus Pharmaceuticals, Inc.
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)
Nonalcoholic Fatty Liver Disease
Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis
This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.
- Trial name
- NCT02029586
- Testing
- MB12066 200mg
- Where
- 10 sites in South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Yungjin Pharm. Co., Ltd.
Non-Alcoholic Steatohepatitis (NASH)
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
The primary objective of this study is to characterize the safety, tolerability and dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with biopsy-proven NASH with advanced liver fibrosis.
- Trial name
- NCT01899859
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Galectin Therapeutics Inc.
Non-alcoholic Steatohepatitis
A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men
This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men. Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by…
- Trial name
- NCT04722653
- Testing
- NNC0194-0499
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Nonalcoholic Steatohepatitis, Type 2 Diabetes Mellitus
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
The purpose of this study is to assess the effect of TEV-45478, as compared with placebo, on liver health and liver fat content in patients with T2DM who also have Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT02769091)
- Testing
- TEV-45478
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Non-alcoholic Fatty Liver Disease
A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men
This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499.
- Trial name
- NCT05742919
- Testing
- NNC0194-0499, NC0194-0499
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Metabolic Dysfunction-Associated SteatoHepatitis (MASH)
A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition
This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH).
- Trial name
- NASHGEN-2 (NCT05519475)
- Testing
- ALN-HSD
- Where
- 71 sites in United States, Japan and 2 more
- Volunteers
- 120 people
- Sponsor
- Regeneron Pharmaceuticals
Nonalcoholic Steatohepatitis (NASH)
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
- Trial name
- NCT05117489
- Testing
- Miricorilant 150 mg, Miricorilant 100 mg, Miricorilant 50 mg
- Where
- 9 sites in United States
- Volunteers
- 70 people
- Sponsor
- Corcept Therapeutics
Metabolic Dysfunction Associated Steatohepatitis
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
This study is open to adults who are at least 18 years old and have: A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or A confirmed liver disease called metabolic-associated steatohepatitis (MASH) BMI of 27…
- Trial name
- NCT06632457
- Testing
- Survodutide
- Where
- 447 sites in United States, Argentina and 35 more
- Volunteers
- 1,590 people
- Sponsor
- Boehringer Ingelheim
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
Nonalcoholic Fatty Liver Disease
Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
- Trial name
- SARONAPLUS (NCT05211284)
- Testing
- Saroglitazar Magnesium 4 mg
- Where
- 8 sites in United States
- Volunteers
- 4 people
- Sponsor
- Zydus Therapeutics Inc.