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A 12-week randomized, patient and investigator blinded, placebo-controlled, parallel group study to investigate the efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH)

Primary objective:- To determine the effect of LIK066 on Liver Function test after 12 weeks of treatmentSecondary objectives: - To determine the effect of LIK066 on intrahepatic lipid after 12 weeks of treatment- To determine the effect of LIK066 on…

A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects

Primary objective:To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjectsSecondary objective:To assess the effects of fenretinide on hepatic steatosis, body weight and body fat…

Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients with Chronic Hepatitis B Virus Infection who are HBeAg-positive

Primary objectives:• To evaluate the safety and tolerability of BMS-914143 as measured by the frequency of SAEs and discontinuations due to AEs;• To assess the HBeAg seroconversion rate at 24 weeks off treatment (Week 72).Secondary objective• To…

A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…

A blinded, randomized, placebo-controlled trial in genotype 1 hepatitis C-infected subjects to evaluate the efficacy, safety, tolerability and pharmacokinetics of repeated doses of TMC435350, with or without peginterferon alpha-2a and ribavirin.

The primary objectives of this trial are the following:- to determine the dose dependency of the antiviral effect of TMC435350 during 1 week ofmonotherapy in treatment-naïve HCV-infected subjects;- to determine the dose dependency of the antiviral…

The effect of bezafibrate on cholestatic itch

To evaluate the effect of bezafibrate in cholestatic pruritus.

Multicenter, double-blind, parallel-group, randomised, 48 weeks, dose-ranging, placebo-controlled phase II trial to evaluate efficacy, safety and tolerability of multiple subcutaneous (s.c.) doses of BI 456906 in patients with non-alcoholic steatohepatitis (NASH) and fibrosis

The main trial objectives are to demonstrate a non-flat dose response curve, to evaluate the size of the treatment effect (using the absolute difference in proportions of patients with histological improvement between BI 456906 and placebo at week…

A Two Part Phase IIa/b Multicentre, Randomised, Double-Blind,
Placebo-Controlled, Parallel Group Dose-ranging Study to Assess
Efficacy, Safety, and Tolerability of the Combination of
Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy
Versus Placebo in Participants with Cirrhosis with Features of
Portal Hypertension

This study has been transitioned to CTIS with ID 2023-505405-17-00 check the CTIS register for the current data. The main objective of this Phase IIa/b study is to demonstrate the effectof zibotentan on HVPG, and that dapagliflozin can mitigate…

Synbiotics and Conditioned Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis.

Primary objective To investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and FOS with and without conditioned vegan LFMT capsules to reduce NASH in patients with fibrotic NASH…

Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with acute on chronic liver failure (ACLF).

The primary objective is:to demonstrate the efficacy of 2 infusions (intravenous [i.v.]) of HepaStem at 1.0 million of cells/kg body weight (BW) (7 days apart) on the overall survival proportion at 90 days post first infusion.The secondary…

A Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) (SEQUOIA)

Primary Objective:• To select a single dose for use in later stage development based on a combined evaluation of safety and pharmacodynamic effects of ARO-AAT

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Dose Levels of Belcesiran in Patients with Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

Primary objectives:Cohort 1 and 21. To evaluate the safety and tolerability of multiple doses of belcesiran in patients with AATLD2. To characterize the pharmacodynamics of belcesiran in patients with AATLDCohort 3 1. To characterize the…

Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH)

Primary objective:* To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASHSecondary objectiveTo study safety and tolerability (adverse events [AEs], laboratory parameters) of…

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose Phase 2 Study
to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from
Nonalcoholic Steatohepatitis (NASH)

Primary objectiveTo evaluate the efficacy of BMS-986263 compared with placebo to improve liver fibrosis in participants with compensated cirrhosis due to NASHSecondary objectives1. To further assess the efficacy of BMS-986263 compared with placebo…

Randomised, double-blind, placebo-controlled and parallel group
trial to investigate the effects of two doses (up-titration to a fixed
dose regimen) of oral BI 685509 on portal hypertension after 24
weeks treatment in patients with clinically significant portal
hypertension (CSPH) in compensated cirrhosis

The trial will compare two doses of BI 685509 (2 mg and 3 mg BID) with placebo, on top of standard of care, in patients with CSPH in compensated alcohol-related cirrhosis. The primary objective is to estimate the mean difference between treatment…

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

Primary objective* To assess the efficacy of EP547 compared to placebo on pruritus as assessed by the Worst Itch Numeric Rating Scale (WI-NRS)Secondary* To assess the efficacy of EP547 compared to placebo on the following:* Pruritus-related quality…

A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of Lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with Nonalcoholic steatohepatitis (NASH) and type 2 Diabetes mellitus (T2DM)

1. Primary Objective The primary objective of this study is to assess the effect of lanifibranor alone compared toplacebo and the effect of lanifibranor in combination with empagliflozin compared to placeboon HbA1c after a 24-week treatment duration…

Metabolic effects of ketohexokinase inhibition in individuals with non-alcoholic fatty liver disease

Primary objective: determining the effect of the ketohexokinase inhibitor, PF-06835919, on hepatic insulin sensitivity in individuals with non-alcoholic fatty liver disease.Secondary objective: determining the effect of the ketohexokinase inhibitor…

A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…

A multi-centre, double-blind, parallel-group, randomised, placebo controlled phase II a study to investigate safety, tolerability, pharmacodynamics, and harmacokinetics of different doses of orally administered BI 1467335 during a 12-week treatment period compared to placebo in patients with clinical evidence of NASH.

The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH…