Clinical trials: Liver Metabolism
Erythropoietic Protoporphyria
Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP
This is a Phase 2, multi-center, double-blind, placebo-controlled, parallel group study of bitopertin to evaluate the safety, tolerability, efficacy, and PPIX concentration change in participants with EPP.
- Trial name
- NCT05308472
- Testing
- DISC-1459
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Disc Medicine, Inc
Acute Intermittent Porphyria
Phase I Gene Therapy Clinical Trial Using the Vector rAAV2/5-PBGD for the Treatment of Acute Intermittent Porphyria
This is a Phase I trial aimed to determine the safety of the investigational gene therapy product (rAAV2/5-PBGD) for the treatment of Acute Intermittent Porphyria (AIP).
- Trial name
- NCT02082860
- Testing
- rAAV2/5-PBGD vector dosage 1, rAAV2/5-PBGD vector dosage 2, rAAV2/5-PBGD vector dosage 3
- Where
- 2 sites in Spain
- Volunteers
- 8 people
- Sponsor
- Digna Biotech S.L.
Splenomegaly, Hepatomegaly
Biomarker for Gaucher Disease: BioGaucher (BioGaucher)
Development of a new mass spectrometry-based biomarker for the early and sensitive diagnosis of Gaucher Disease from blood (plasma)
- Trial name
- BioGaucher (NCT01331642)
- Where
- 4 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Type 2 Diabetes
Longitudinal Assessment of Multiple Organs in Patients With Type 2 Diabetes
MODIFY study is a multi-centre prospective, longitudinal, observational cohort study which aims to recruit 150 adult patients with type 2 diabetes recruited from community, primary care or secondary care settings.
- Trial name
- MODIFY (NCT04114682)
- Testing
- Multi parametric MRI scan
- Where
- 4 sites in United Kingdom
- Volunteers
- 135 people
- Sponsor
- Perspectum
NASH - Nonalcoholic Steatohepatitis, NAFLD
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
A multi-centre randomised controlled trial to determine the implementation and health care cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic fatty liver disease (NAFLD) across several…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, Metabolic Syndrome
- Trial name
- RADIcAL1 (NCT03289897)
- Testing
- LiverMultiScan
- Where
- 11 sites in Germany, Netherlands and 2 more
- Volunteers
- 801 people
- Sponsor
- Perspectum
Ulcerative Colitis, Crohn Disease
Systems Biology of Gastrointestinal and Related Diseases
This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and…
- Conditions
- Ulcerative Colitis, Crohn Disease, Obesity, Colon Polyp
- Trial name
- NCT05579444
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Viome
Metabolic Syndrome X
Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease
The purpose of this study is the evaluation of the effects in obese patients with metabolic syndrome on the composition of the intestinal microbiota, markers of the syndrome (hypertension, dyslipidemia, inflammation biomarkers…
- Trial name
- PROSIR (NCT02972567)
- Testing
- Lactobacillus spp, Control
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Biosearch S.A.
Non-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic…
- Trial name
- NCT02354976
- Testing
- Omega-3 carboxylic acid, Fenofibrate 200mg
- Where
- 4 sites in Sweden
- Volunteers
- 78 people
- Sponsor
- AstraZeneca
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital…
- Trial name
- NCT06493253
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- United States
- Volunteers
- 1,519 people
- Sponsor
- PharmaNest, Inc
Wilson Disease
Early Access Program for ALXN1840 in Patients With Wilson Disease
This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.
- Trial name
- NCT05686564
- Testing
- ALXN1840
- Sponsor
- Alexion Pharmaceuticals, Inc.
Obese
Study of NGM313 in Obese Participants
The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants
- Trial name
- NCT03298464
- Testing
- NGM313, Pioglitazone
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Erythropoietic Protoporphyria
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.
- Trial name
- NCT06388642
- Testing
- Afamelanotide 16mg implant
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 28 people
- Sponsor
- Clinuvel Europe Limited
Hepatitis B
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Engerix™-B in Adults With or Without Type 2 Diabetes Mellitus
This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.
- Trial name
- NCT01627340
- Testing
- Engerix™-B vaccine
- Where
- 22 sites in United States, Australia and 2 more
- Volunteers
- 667 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV, HIV-Infections
The Visceral Adiposity Measurement and Observation Study
The Visceral Adiposity Measurement and Observation Study
- Conditions
- HIV, HIV-Infections, HIV-1-infection, HIV I Infection
- Trial name
- VAMOS (NCT05383456)
- Testing
- Diagnostic Test, HIV Anti-retroviral Background Therapy
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- Theratechnologies
Wilson Disease
Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients
The main purpose of the study was to evaluate the efficacy of ALXN1840 (formerly WTX101) for 24 weeks on non-ceruloplasmin-bound copper (NCC) concentrations adjusted for molybdenum plasma concentration in participants newly…
- Trial name
- NCT02273596
- Testing
- ALXN1840
- Where
- 9 sites in United States, Austria and 3 more
- Volunteers
- 29 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Erythropoietic Protoporphyria
Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP)
Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is not yet available on…
- Trial name
- NCT00979745
- Testing
- Afamelanotide
- Where
- 8 sites in Finland, France and 4 more
- Volunteers
- 74 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Cholesterol Ester Storage Disease (CESD), Lysosomal Acid Lipase Deficiency
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency
This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the study was to evaluate the long-term safety and tolerability of sebelipase alfa in participants with liver dysfunction due to lysosomal acid…
- Conditions
- Cholesterol Ester Storage Disease (CESD), Lysosomal Acid Lipase Deficiency, LAL-Deficiency
- Trial name
- NCT01488097
- Testing
- sebelipase alfa
- Where
- 10 sites in United States, Canada and 3 more
- Volunteers
- 8 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Volunteers, Hepatic Insufficiency
A Single Dose Study of LY2605541 in Participants With Liver Impairment
The primary purpose of this study is to help answer the following research questions: To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those…
- Conditions
- Healthy Volunteers, Hepatic Insufficiency, Diabetes Mellitus, Type 2
- Trial name
- NCT01751399
- Testing
- LY2605541
- Where
- 2 sites in Germany, Hungary
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Metabolic Dysfunction-associated Steatohepatitis
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
- Trial name
- NEBULA-1 (NCT07701993)
- Testing
- Efimosfermin alfa
- Where
- 30 sites in United States, Japan
- Volunteers
- 1,740 people
- Sponsor
- GlaxoSmithKline
Metabolic Dysfunction-associated Steatohepatitis
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH.
- Trial name
- NEBULA-2 (NCT07704892)
- Testing
- Efimosfermin alfa
- Where
- 35 sites in United States, Japan
- Volunteers
- 380 people
- Sponsor
- GlaxoSmithKline