Clinical trials: Liver Metabolism
Erythropoietic Protoporphyria
Multicentre Phase III Erythropoietic Protoporphyria Study
This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in patients with Erythropoietic Protoporphyria (EPP).
- Trial name
- NCT04053270
- Testing
- Afamelanotide
- Volunteers
- 100 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Pompe Disease
A Study of S-606001 as Monotherapy in Participants With Late-onset Pompe Disease (LOPD)
The primary purpose of this study is to evaluate the safety and tolerability profile of S-606001 in participants with LOPD.
- Trial name
- NCT07787650
- Testing
- S-606001
- Volunteers
- 15 people
- Sponsor
- Shionogi
Wilson's Disease
Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride
Decentralized study to assess patient reported treatment satisfaction comparing their current standard-of-care Wilson's Disease (WD) treatment with a new once-daily Trientine (TETA) 4HCl formulation.
- Trial name
- NCT07010575
- Testing
- New TETA 4HCl Formulation, Standard of Care
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Orphalan
Diabetes
A Trial of SP2086 With Hepatic Insufficiency
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
- Trial name
- NCT06035406
- Testing
- Retagliptin Phosphate Tablet
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Obesity/Overweight
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function
This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or…
- Trial name
- NCT07144098
- Testing
- GZR18 injection
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Diabetes Mellitus, Type 2, Hypertriglyceridemia
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
The design of the Phase 2 clinical trial includes the following elements: Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs.
- Conditions
- Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease
- Trial name
- NCT05464784
- Testing
- MN-001
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MediciNova
Hepatic Encephalopathy
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
- Trial name
- NCT00597909
- Testing
- sodium phenylacetate and sodium benzoate injection 10% / 10%
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Amgen
Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM.
- Trial name
- NCT00150085
- Testing
- cyclosporine micro-emulsion
- Volunteers
- 50 people
- Sponsor
- Novartis
MASH, MASLD
Global Research Initiative for Patients Screening on MASH
GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe…
- Conditions
- MASH, MASLD, MASH With Fibrosis, Fibrosis, Liver
- Trial name
- GRIPonMASH (NCT05651724)
- Where
- 13 sites in Belgium, Czechia and 8 more
- Volunteers
- 10,000 people
- Sponsor
- Julius Clinical
Hepatic Encephalopathy
Revealing Engagement Patterns Among Hepatic Encephalopathy Patients
This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in hepatic encephalopathy clinical trials.
- Trial name
- NCT06201988
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Power Life Sciences Inc.
Non-alcoholic Fatty Liver Disease
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and…
- Trial name
- ZENITH-1 (NCT07221227)
- Testing
- Efimosfermin alfa
- Where
- 91 sites in United States, Australia and 7 more
- Volunteers
- 1,200 people
- Sponsor
- GlaxoSmithKline
Obesity
Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat to establish whether there is any indication of liver toxicity.
- Trial name
- NCT01332448
- Testing
- Orlistat 120, Orlistat 60
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
NASH - Nonalcoholic Steatohepatitis, NAFLD
Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, T2DM (Type 2 Diabetes Mellitus)
- Trial name
- NCT03291249
- Testing
- Foralumab, Omeprazole 20mg
- Sponsor
- Tiziana Life Sciences LTD
NASH/MASH, NAFLD/MASLD
A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
- Trial name
- NCT06161571
- Testing
- Efruxifermin
- Where
- 211 sites in United States, Argentina and 11 more
- Volunteers
- 700 people
- Sponsor
- Akero Therapeutics, Inc
Erythropoietic Protoporphyria
A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
The main objectives of the study were to evaluate the safety and tolerability of afamelanotide by measuring treatment emergent adverse events (AEs) and to determine whether afamelanotide can improve the quality of life of EPP…
- Trial name
- NCT04578496
- Testing
- Afamelanotide
- Volunteers
- 16 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Hepatic Encephalopathy
Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin (PROSPER)
This study evaluates hepatic encephalopathy (HE) and liver-related hospitalization rates and duration of stay in patients with HE treated with rifaximin-α 550mg compared to patients receiving other therapies.
- Trial name
- PROSPER (NCT02488993)
- Testing
- Prospective Phase Rifaximin-α 550mg, Prospective Phase No Rifaximin-α 550mg, Retrospective Phase
- Where
- United Kingdom
- Volunteers
- 389 people
- Sponsor
- Norgine
Wilson Disease
Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease
This is a multicenter, randomized, open-label study with an active standard-of-care comparator (penicillamine)
- Trial name
- NCT03539952
- Testing
- Penicillamine (D1-W12), TETA 4HCL (W12-60), Penicillamine (W12-W60)
- Where
- 15 sites in United States, Belgium and 7 more
- Volunteers
- 77 people
- Sponsor
- Orphalan
Metabolic Dysfunction-associated Steatohepatitis
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)
This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD).
- Trial name
- NCT07462455
- Testing
- ACT500 tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatic Steatosis
Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes
The purpose is to assess the Safety, Tolerability, and Pharmacodynamics effect of IONIS DGAT2Rx in up to 45 Adult Patients with Type 2 Diabetes.
- Trial name
- NCT03334214
- Testing
- IONIS DGAT2Rx
- Where
- 22 sites in Canada, Hungary and 2 more
- Volunteers
- 44 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
HIV Infections, Hepatitis B
ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency
The purpose of this study is to determine the safety and effects in HIV patients of supplementation (4-20 fl. oz. daily) with ProAlgaZyme, a novel fermentation product of a freshwater algae ecosystem, on markers of immune status…
- Conditions
- HIV Infections, Hepatitis B, Dyslipidemia
- Trial name
- NCT00493506
- Testing
- ProAlgaZyme
- Where
- Cameroon
- Volunteers
- 59 people
- Sponsor
- Health Enhancement Products, Inc.