Clinical trials: Hepatobiliary Disease
Severe Hypertriglyceridemia (sHTG), Hypertriglyceridemia
A Phase III Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of weekly subcutaneous DR10624 injection in adult patients with severe hypertriglyceridemia (sHTG).
- Trial name
- NCT07693777
- Testing
- DR10624 Injection
- Where
- China
- Volunteers
- 480 people
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
- Trial name
- NCT03684811
- Testing
- FT-2102, Azacitidine, Nivolumab
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 93 people
- Sponsor
- Forma Therapeutics, Inc.
Alcohol-related Liver Disease
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on liver damage and alcohol use in participants with alcoholic liver disease.
- Trial name
- NCT06409130
- Testing
- NNC0194-0499, Semaglutide, Cagrilintide + semaglutide
- Where
- 102 sites in United States, Australia and 12 more
- Volunteers
- 270 people
- Sponsor
- Novo Nordisk A/S
Non-Alcoholic Fatty Liver Disease
Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).
- Trial name
- NCT05292911
- Testing
- ALT-801
- Where
- 13 sites in United States
- Volunteers
- 64 people
- Sponsor
- Altimmune, Inc.
Alpha 1-Antitrypsin Deficiency
An Extension Study of Belcesiran in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATLD)
This is a Phase 2, multicenter, open-label extension of Study DCR-A1AT-201, designed to evaluate the long-term safety and further characterize the pharmacodynamics (PD) of belcesiran in adult patients with PiZZ AATLD.
- Trial name
- NCT05146882
- Testing
- Belcesiran
- Where
- New Zealand
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
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 and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects
- Trial name
- NCT04481594
- Testing
- HPN-01
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Hepanova Inc.
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.
- Trial name
- NCT03976401
- Testing
- EFX
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 110 people
- Sponsor
- Akero Therapeutics, Inc
Non-Alcoholic Fatty Liver Disease
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).
- Trial name
- NCT05006885
- Testing
- ALT-801
- Where
- 15 sites in United States
- Volunteers
- 95 people
- Sponsor
- Altimmune, Inc.
Non-alcoholic Steatohepatitis
Investigate Safety, Tolerability, PK/PD of J2H-1702 in Healthy Females
Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects.
- Trial name
- NCT06308874
- Testing
- Amg dose administration group, Bmg dose administration group
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- J2H Biotech
NASH - Nonalcoholic Steatohepatitis
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \& F≥2 from those without.
- Trial name
- NCT04054310
- Testing
- Liver Multi Scan
- Where
- 7 sites in United States
- Volunteers
- 225 people
- Sponsor
- Perspectum
Advanced Chronic Liver Disease, Healthy Participants
A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants
The purpose of this study is to measure the effect of multiple doses of AZD2389 on the pharmacokinetics (PK) of midazolam, caffeine, and bupropion in healthy participants.
- Trial name
- CRIOLLO (NCT06973005)
- Testing
- AZD2389, Midazolam, Caffeine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Rheumatoid Arthritis, Non-Alcoholic Steatohepatitis
A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants
The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.
- Trial name
- NCT05053165
- Testing
- LB-P6, LB-P8
- Where
- Australia
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- LISCure Biosciences
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.
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.
Chronic Hepatitis B
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.
- Trial name
- NCT02579382
- Testing
- TDF, Vesatolimod
- Where
- 21 sites in United States, Canada and 6 more
- Volunteers
- 192 people
- Sponsor
- Gilead Sciences
Lesion
A Randomized, Open, Parallel, Optimal Injection Rate-Finding Study for E7337 in Dynamic CT of the Liver in Patients With Liver Disease
To establish the optimum injection rate for E7337 (Iomeron 350) in dynamic CT in patients who have hepatic lesions.The primary endpoint for efficacy is the contrast enhancement effect in the early arterial phase, and the primary…
- Trial name
- NCT00165620
- Testing
- Iomeprole
- Where
- 2 sites in Japan
- Sponsor
- Eisai Limited
Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
This randomized clinical trial aims to compare the effect of the pioglitazone and SGLT2 inhibitor combination on liver fat mass, as compared to either drug used alone, with or without background medical therapy of metformin…
- Conditions
- Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis, NAFLD
- Trial name
- NCT04976283
- Testing
- Pioglitazone, Empagliflozin, Pioglitazone + Empagliflozin
- Where
- Pakistan
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Getz Pharma
NASH - Nonalcoholic Steatohepatitis, Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Portal Hypertension
- Trial name
- NCT03439189
- Testing
- Methacetin Breath Test, Emricasan
- Where
- France
- Volunteers
- 343 people
- Sponsor
- Meridian Bioscience, Inc.
Non-alcoholic Fatty Liver Disease
Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome
The study is designed to assess the safety and efficacy of different doses and dosing regimens of Runihol, tablets, enteric coated, produced by "NTFF" POLYSAN" (Russia), in prevention of liver disease progression in patients with…
- Trial name
- NCT02930161
- Testing
- Runihol
- Where
- 3 sites in Russia
- Volunteers
- 35 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company