Clinical trials: Liver Metabolism
Healthy, Liver Diseases
A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906
This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts.
- Conditions
- Healthy, Liver Diseases, Obesity
- Trial name
- NCT05296733
- Testing
- BI 456906
- Where
- 13 sites in United States, Germany and 4 more
- Volunteers
- 82 people
- Sponsor
- Boehringer Ingelheim
MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
AGED Diagnostics Clinical Validation Study
Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis: This study aims to validate two investigational blood tests developed by AGED Diagnostics for the…
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Fibrosis and Cirrhosis of Liver, MetALD
- Trial name
- NCT07867574
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Active Genomes Expressed Diagnostics, Corp
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH).
- Trial name
- NCT07854782
- Testing
- ALN-CIDEB
- Where
- 4 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Regeneron Pharmaceuticals
Wilson's Disease
Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Efficacy of LY-M003 Injection in Adult Patients With Wilson's Disease
This is a multicenter, open-label, single-arm, single-dose Phase I/II clinical study. It aims to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of LY-M003…
- Trial name
- NCT07641140
- Testing
- LY-M003 Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Lingyi Biotech Co., Ltd.
Obesity, Nonalcoholic Steatohepatitis
ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
This study was a FIH, Phase 1, randomized, double-blind, placebo-controlled, 2-part single-ascending dose (SAD) and multiple-ascending dose (MAD) study of ALT-801 (pemvidutide) in healthy overweight and obese subjects.
- Trial name
- NCT04561245
- Testing
- ALT-801
- Where
- Australia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease
This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease.
- Trial name
- NCT01277094
- Testing
- RO5093151
- Where
- 4 sites in Austria, Germany
- Volunteers
- 82 people
- Sponsor
- Hoffmann-La Roche
Infantile Refsum's Disease, Zellweger Syndrome
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II.
- Conditions
- Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders
- Trial name
- NCT00007020
- Testing
- Cholic Acids
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Wilson Disease
A Phase 1/2/3 Study of UX701 Gene Therapy in Adults With Wilson Disease
The primary objectives of this study are to evaluate the safety of single IV doses of UX701 in patients with Wilson disease, to select the UX701 dose with the best benefit/risk profile based on the totality of safety and efficacy…
- Trial name
- NCT04884815
- Testing
- UX701, Standard of Care (SOC)
- Where
- 16 sites in United States, Portugal and 2 more
- Volunteers
- 82 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Contraception, Liver Metabolism
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.
- Conditions
- Contraception, Liver Metabolism, Hemostasis Parameter
- Trial name
- NCT02957630
- Testing
- 15 mg E4/3 mg DRSP, 30 mcg EE/150 mcg LNG, 20 mcg EE/3 mg DRSP
- Where
- Netherlands
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Estetra
Overweight and Obesity, Cardiovascular Diseases
Study Consortium for Evaluation of RNPC Program in Obese and Overweight Patients (SCOOP-RNPC)
The investigators hypothesize that weight loss obtained with the French RNPC weight reduction program is beneficial for the general health of overweight/obese patients in the medium term.
- Conditions
- Overweight and Obesity, Cardiovascular Diseases, Metabolic Disease, Diabete Type 2
- Trial name
- SCOOP-RNPC (NCT05857319)
- Testing
- Nutritional Psycho-Behavioral Reeducation Program
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Groupe Éthique et Santé
Overweight, Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）
This is a multicenter, randomized, open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 9 mg QW versus Semaglutide 2.4 mg QW in overweight or obese (BMI≥27kg/m2) MAFLD subjects.
- Trial name
- NCT06884293
- Testing
- IBI362, semaglutide
- Where
- China
- Volunteers
- 479 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Acute on Chronic Liver Failure (ACLF), Hepatic Encephalopathy (HE)
RENEW: Study of Porcine Liver Support in Participants With Acute-on-Chronic Liver Failure
This is a Phase 1/2, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants…
- Trial name
- NCT07429838
- Testing
- metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx), EGEN-5784 (genetically engineered porcine liver)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- eGenesis, INC
Obesity, Type 2 Diabetes (T2D)
A Retrospective Real-World Cohort Study
The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort…
- Conditions
- Obesity, Type 2 Diabetes (T2D), Prediabetes, Cardiovascular Disease (CVD)
- Trial name
- SCALA-TK-CM (NCT07781371)
- Testing
- No treatment given
- Where
- Denmark
- Volunteers
- 100,000 people
- Sponsor
- Novo Nordisk A/S
Non-Alcoholic Fatty Liver Disease
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)
A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
- Trial name
- NCT04951219
- Testing
- Resmetirom
- Where
- 76 sites in United States, Puerto Rico
- Volunteers
- 810 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.
- Trial name
- NCT04618744
- Testing
- ORMD-0801 (Insulin) capsule 8 mg BD
- Where
- 3 sites in United States, Israel
- Volunteers
- 32 people
- Sponsor
- Oramed, Ltd.
Mild Hepatic Encephalopathy
AST-120 Used to Treat Mild Hepatic Encephalopathy
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
- Trial name
- ASTUTE (NCT00867698)
- Testing
- AST-120
- Where
- 38 sites in United States
- Volunteers
- 148 people
- Sponsor
- Ocera Therapeutics
NAFLD, Diabetes Mellitus, Type 2
Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS…
- Conditions
- NAFLD, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Fatty Liver, Nonalcoholic
- Trial name
- NCT03371355
- Testing
- ISIS 703802 40 mg, ISIS 703802 80 mg, ISIS 703802 20 mg
- Where
- 42 sites in United States, Canada
- Volunteers
- 105 people
- Sponsor
- Akcea Therapeutics
Detoxification Response
Guided Metabolic Detox Program
Adequate antioxidant supply is essential for maintaining metabolic homeostasis and reducing oxidative stress during detoxification.
- Trial name
- NCT06061289
- Testing
- SP Detox Program
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Standard Process Inc.
Diabetes Mellitus, Type 2, Non-Alcoholic Fatty Liver Disease
A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes…
- Trial name
- NCT03060538
- Testing
- BFKB8488A
- Where
- 18 sites in United States, Canada
- Volunteers
- 154 people
- Sponsor
- Genentech, Inc.
Metabolic Dysfunction-Associated Fatty Liver Disease
Evaluate the Effect of Synbiotics on MAFLD
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota, while Vitamin E and omega 3 are safe and effective at…
- Trial name
- MAFLD-RCT (NCT06537882)
- Testing
- G-NiiB synbiotics formula (SLP07)
- Where
- Hong Kong
- Volunteers
- 54 people
- Sponsor
- GenieBiome Limited