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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

Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical trial.

The aim of this study is to assess the efficacy of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis to halt the progression of the disease as assessed by prevention of the development of ACLF.

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 randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

This study has been transitioned to CTIS with ID 2023-508248-23-00 check the CTIS register for the current data. Primary objectivesThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis and consists of 2…

A PHASE I, SPONSOR-OPEN, INVESTIGATORBLINDED,SUBJECT-BLINDED, MULTI-CENTER,
PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS
AND PHARMACODYNAMICS OF ORAL ADMINISTRATION OF RO7020531: (1). SINGLE
AND MULTIPLE ASCENDING DOSES IN HEALTHY MALE AND FEMALE SUBJECTS; (2). 6-WEEK
TREATMENT OF VIROLOGICALLY SUPPRESSED PATIENTS WITH CHRONIC HEPATITIS B VIRUS
INFECTION

OBJECTIVESPrimary ObjectivesThe primary objective is:* To assess the safety and tolerability of 6 weeks of treatment with RO7020531 administered orally to virologically suppressed chronic hepatitis B (CHB) patients.Secondary ObjectivesThe secondary…

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis

To evaluate the effect of Obeticholic Acid on clinical outcomes in subjects with primary biliary cholangitis

Effect of 4 weeks of oral D. piger on safety, pharmacokinetics and ethanol metabolism in overweight individuals (2023)

To assses safety, gut engraftment and effects on sugar- and alcohol metabolism of d. piger in individuals with increased waist circumference.

A three-part, phase 1, randomized, controlled, dose-escalation study of INT-787 following single or multiple dose administration in healthy subjects.

In this study we will investigate how safe the new compound INT-787 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent multiple doses of INT-787 are absorbed, transported,…

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…

The effect of semaglutide in non-cirrhotic non-alcoholic steatohepatitis

This study has been transitioned to CTIS with ID 2023-506962-30-00 check the CTIS register for the current data. Primary objectivesThe trial has two parts, a part 1 and a part 2, with distinctive objectives and endpoints.Part 1 of the trial: To…

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…

Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

This study has been transitioned to CTIS with ID 2023-510200-42-00 check the CTIS register for the current data. Primary:• To show the superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing…

A phase 1, first-in-human, 2-part, randomized, double-blind, placebo
controlled, single ascending dose and sequential, open-label, multiple
ascending dose study to evaluate the safety, tolerability,
pharmacodynamics, and pharmacokinetics of VIS171 in healthy
participants and participants with autoimmune disease(s)

The purpose of this first-in-human (FIH) study is to assess the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (single ascending dose [SAD] - Part A) as well as in…

A randomized, double-blind, placebo-controlled, alternating panel single ascending dose, sequential multiple ascending dose, and food effect study of FM101 in healthy male and female volunteers

The purpose of this study is to investigate how safe the new compound FM101 is and how well it is tolerated when it is administered to healthy volunteers. FM101 has not been administered to humans before. It has been previously tested in the…