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Nonalcoholic Steatohepatitis clinical trials

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NCT ID: NCT06365580 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Dose Escalation Study of Kylo-0603 in Healthy Subjects

Start date: May 23, 2023
Phase: Phase 1
Study type: Interventional

This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.

NCT ID: NCT05979779 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis

Start date: September 5, 2023
Phase: Phase 2
Study type: Interventional

This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 in subjects with nonalcoholic steatohepatitis (NASH). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) during this time. The end-of-study visit will take place approximately 4 weeks after the last dose of the study drug (Week 30).

NCT ID: NCT05877547 Recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease

A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

Start date: June 23, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

NCT ID: NCT05733897 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis

Start date: June 10, 2022
Phase:
Study type: Observational

Nonalcoholic steatohepatitis (NASH) is a serious type of nonalcoholic fatty liver disease (NAFLD), which is characterized by lobular inflammation and apoptosis resulting from hepatic steatosis in the absence of excessive alcohol consumption. If NASH are not controlled well, it will advance to liver fibrosis, cirrhosis, and even hepatocellular carcinoma. However, there is no approved treatments currently. The investigators aim to clarify whether hydroxychloroquine relieves nonalcoholic steatohepatitis by reviewing medical records from our out-patient-clinic patients who accept the treatment of hydroxychloroquine (Plaquenil®).

NCT ID: NCT05720663 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Predicting Outcomes in Nonalcoholic Steatohepatitis With Advanced Fibrosis

Start date: April 19, 2023
Phase:
Study type: Observational

Nonalcoholic Steatohepatitis (NASH) is a condition with increased amount of fat, inflammation and scarring in the liver. In compensated cirrhosis, the liver is coping with this damage and maintaining its important functions. Decompensation occurs when the liver becomes unable to perform all of its functions adequately. Variceal hemorrhage (bleeding from abnormal vessels in the liver called varices), Ascites (abnormal build-up of fluid in the abdomen), and Encephalopathy (brain confusion as a result of the liver not being able to get rid of toxic substances) are three symptoms of liver decompensation. The purpose of this research study is to investigate better ways to routinely monitor the condition of patients with NASH with compensated cirrhosis and to better pinpoint the development of decompensation in the livers of these patients.

NCT ID: NCT05680233 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis

Start date: January 23, 2023
Phase: Phase 1
Study type: Interventional

This study is a Phase 1, first-in-human single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.

NCT ID: NCT05655221 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects

Start date: August 30, 2022
Phase: Phase 1
Study type: Interventional

To evaluate the safety, tolerability, and immunogenicity of B1344 by single subcutaneous (s.c.) injection in healthy subjects

NCT ID: NCT05526144 Recruiting - Liver Fibrosis Clinical Trials

Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans

Start date: April 1, 2023
Phase: Phase 2
Study type: Interventional

Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.

NCT ID: NCT05430178 Recruiting - Obesity Clinical Trials

Metabolic Pathology of Pediatric NAFLD

Start date: May 25, 2022
Phase: N/A
Study type: Interventional

Nonalcoholic fatty liver disease (NAFLD) is now the most common liver disease worldwide and affects nearly 40% of obese youth and up to 10% of the general pediatric population. Some features of NAFLD are similar in children and adults, yet fibrosis and inflammation are more common in the portal zone and occur earlier in pediatric NAFLD patients than adults. This portends a rapid progression to end-stage liver disease in early adulthood. For the majority of children with NAFLD, mechanisms driving the origin and rapid progression of disease remain unknown. Thus, there is a critical, unmet need to study the specific underlying patterns of metabolic and molecular changes in the liver underlying the development and progression unique to children with NAFLD. This proposal will test the hypotheses that children with NAFLD have excess glucose and lipid produced by the liver, that those events are regulated by specific variations in the amount and location of RNAs and proteins in liver, and that the concentration of specific micro-RNAs in the blood can be used as a biomarker for NAFLD in pediatric patients.

NCT ID: NCT05330923 Recruiting - HIV/AIDS Clinical Trials

Effect of NNRTI or INSTI on Nonalcoholic Steatosis in HIV/AIDS Patients

Start date: May 1, 2022
Phase:
Study type: Observational

Identifying patients at risk of NAFLD(Nonalcoholic fatty liver disease), especially severe disease with NASH(nonalcoholic steatohepatitis) and fibrosis, is critical. Prevalence of NAFLD in PLWH(People Living With HIV) evaluated by different imaging techniques including US (ultrasonography), elastography, CT(computed tomography ), and magnetic resonance varies from 13% to 58.6% in all published studies. In previous studies, the effect of ART(Anti-Retroviral Therapy) on NAFLD was limited. A cross-sectional analysis found that INSTI(Integrase strand transfer inhibitor) was associated with a higher prevalence of steatosis in AIDS (acquired immunodeficiency syndrome) patients. However, it is not clear whether there is a difference in the degree of nonalcoholic steatosis between AIDS patients receiving NNRTI(non-nucleoside reverse transcriptase inhibitors). Therefore, the investigators plan to conduct a prospective study to assess whether there is any difference in the degree of nonalcoholic steatosis and fibrosis between Chinese HIV(human immunodeficiency virus)/AIDS patients after initial treatment with NNRTI or INSTI, or switching from NNRTI to INSTI.