Clinical trials: Liver Metabolism
Acute Hepatic Porphyria, Acute Intermittent Porphyria
ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).
- Conditions
- Acute Hepatic Porphyria, Acute Intermittent Porphyria, Porphyria, Acute Intermittent, Acute Porphyria
- Trial name
- NCT03338816
- Testing
- Givosiran
- Where
- 36 sites in United States, Australia and 16 more
- Volunteers
- 94 people
- Sponsor
- Alnylam Pharmaceuticals
Hepatic Encephalopathy
Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE)…
- Trial name
- RED-C-3132 (NCT05297448)
- Testing
- Rifaximin SSD
- Where
- 188 sites in United States, Australia and 15 more
- Volunteers
- 517 people
- Sponsor
- Bausch Health Americas, Inc.
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
- Trial name
- NCT06108219
- Testing
- Miricorilant (Cohort A), Miricorilant (Cohort B)
- Where
- 77 sites in United States, India and 1 more
- Volunteers
- 175 people
- Sponsor
- Corcept Therapeutics
Metabolic Dysfunction-Associated Steatotic Liver Disease
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease…
- Trial name
- NCT07165028
- Testing
- Tirzepatide, Retatrutide
- Where
- 563 sites in United States, Argentina and 32 more
- Volunteers
- 4,500 people
- Sponsor
- Eli Lilly and Company
Non-alcoholic Steatohepatitis
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy.
- Trial name
- NCT03969719
- Testing
- PF-06835919
- Where
- 106 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Pfizer
Hyperoxaluria, Nonalcoholic Fatty Liver Disease
A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria
The purpose of this study is to test the safety of BMN 255 and to learn about the effect BMN 255 has on you and your hyperoxaluria associated with NAFLD, and compare these effects with a placebo.
- Conditions
- Hyperoxaluria, Nonalcoholic Fatty Liver Disease, Kidney Stone
- Trial name
- NCT06138327
- Testing
- BMN 255
- Where
- 7 sites in United States
- Sponsor
- BioMarin Pharmaceutical
Hepatic Encephalopathy
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.
- Trial name
- NCT04128462
- Testing
- MNK-6105, Standard of Care
- Sponsor
- Mallinckrodt
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency
Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia.
- Conditions
- Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease, Ornithine Carbamoyltransferase Deficiency (Disorder), Urea Cycle Disorders, Inborn
- Trial name
- NCT06255782
- Testing
- ECUR-506
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 20 people
- Sponsor
- iECURE, Inc.
Obesity
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
This study is open to adults with obesity. People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study.
- Trial name
- NCT05202353
- Testing
- BI 456906, Semaglutide
- Where
- Netherlands
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant.
- Trial name
- NCT07335601
- Testing
- Resmetirom
- Where
- 17 sites in United States, Canada
- Volunteers
- 120 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Liver Dysfunction
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction
The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin
- Trial name
- NCT02754219
- Testing
- Evogliptin
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Wilson's Disease
A Phase I/II Study of VTX-801 in Adult Patients With Wilson's Disease
The objectives of this clinical trial are to assess, for up to 5 years, the safety, tolerability and pharmacological activity of a single ascending doses of VTX-801, a gene therapy, administered intravenously (IV) to adult…
- Trial name
- GATEWAY (NCT04537377)
- Testing
- VTX-801
- Where
- 10 sites in United States, Denmark and 2 more
- Volunteers
- 4 people
- Sponsor
- Vivet Therapeutics SAS
Erythropoietic Protoporphyria
HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP
This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.
- Trial name
- NCT05883748
- Testing
- DISC-1459
- Where
- 26 sites in United States, Australia and 9 more
- Volunteers
- 230 people
- Sponsor
- Disc Medicine, Inc
Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)
INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP
To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.
- Trial name
- INSPIRE (NCT06144840)
- Testing
- Dersimelagon
- Where
- 35 sites in United States, Australia and 9 more
- Volunteers
- 165 people
- Sponsor
- Tanabe Pharma America, Inc.
Acute Intermittent Porphyria (AIP), Acute Hepatic Porphyria (AHP)
A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)
The purpose of this study is to evaluate the effect of givosiran on the pharmacokinetics of the 5-probe cocktail of midazolam, caffeine, losartan, omeprazole, and dextromethorphan, and their metabolites, in asymptomatic patients…
- Conditions
- Acute Intermittent Porphyria (AIP), Acute Hepatic Porphyria (AHP), Porphyria, Acute Intermittent, Acute Porphyria
- Trial name
- NCT03505853
- Testing
- Givosiran, 5-probe cocktail
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Alnylam Pharmaceuticals
Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)
A Study to Investigate PORT-77 Oral Dosing Compared With Placebo in Participants With Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP)
PATHWAY is a Phase 2b/3 clinical study with an Open-Label Extension (OLE). It tests PORT-77 in patients with EPP, EPP2, and XLP.
- Conditions
- Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP), EPP2
- Trial name
- PATHWAY (NCT07820085)
- Testing
- PORT-77
- Where
- 2 sites in United States
- Volunteers
- 225 people
- Sponsor
- Portal Therapeutics, Inc.
Non-Alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)
To build a registry of diabetic volunteers by inviting them to get a LiverMultiScan and collecting their contact information to seek interest in participating in future research studies.
- Trial name
- NCT04336800
- Testing
- LiverMultiscan
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Perspectum
Non-Alcoholic Steatohepatitis
A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose
The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.
- Trial name
- NCT02571192
- Testing
- SHP626, 5.95 μCi RAD
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Mirum Pharmaceuticals, Inc.
Nonalcoholic Steatohepatitis (NASH)
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups…
- Trial name
- ARMOR (NCT04104321)
- Testing
- Aramchol free acid
- Where
- 2 sites in United States
- Volunteers
- 157 people
- Sponsor
- Galmed Research and Development, Ltd.
MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
- Trial name
- NCT07581951
- Testing
- HSK31679
- Where
- China
- Volunteers
- 886 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.