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Nash clinical trials

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NCT ID: NCT06348706 Completed - Clinical trials for Diabetes Mellitus, Type 1

Effect of Dipeptidyl Peptidase- 4 Inhibitors on Non-Alcoholic Steatohepatitis and Type 1 Diabetes

Start date: November 10, 2022
Phase: Phase 3
Study type: Interventional

Background: Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that can precipitate to advanced fibrosis and leads to cardiovascular morbidity and mortality. Many patients with type 1 diabetes mellitus (T1DM) had histological evidence of steatosis and met the histological criteria for NASH. Matrix metalloproteinase-14 (MMP-14) is a type 1 transmembrane proteinase expressed in liver fibrosis and is involved in the development of atherosclerosis and cardiovascular disease. Hepatic dipeptidyl peptidase-4 (DPP-4) expression in NAFLD may be directly associated with hepatic lipogenesis and liver injury. Some studies showed the beneficial effect of dipeptidyl peptidase-4 (DDP-4) inhibitors in NAFLD/NASH for their role in improving hepatic glucose metabolism. Vildagliptin, a DPP-4 inhibitor, could be promising therapeutic agents for NAFLD/NASH. To the best of our knowledge, no previous study assessed the role of DPP-4 inhibitors in adolescent patients with T1DM and NASH. Objectives: This randomized-controlled clinical trial assessed the impact of the oral DPP-4 inhibitor, vildagliptin, as an add-on therapy on NASH in adolescents with T1DM as well as its effect on glycemic control, lipid profile, MMP-14 levels and CIMT as a marker for subclinical atherosclerosis. Methods: This study included 60 adolescents with T1DM and NASH with a mean age 15.6 ± 2.08 years and disease duration ≥ 5 years. Forty age- and sex-matched healthy subjects with a mean age 14.9 ± 3.2 years were enrolled as healthy controls to compare MMP-14 levels. T1DM patients were randomly assigned to receive oral vildagliptin (50 mg daily) with lunch meal for six months or not. Fasting and 2 hours post-prandial blood glucose levels, HbA1c, liver function tests, fasting lipid profile, hepatic steatosis index and triglyceride glucose (TyG) index were assessed. MMP-14 levels were measured by enzyme-linked immunosorbent assay among all patients and healthy controls. CIMT was assessed using Doppler ultrasound and transient elastography with controlled attenuation parameter (CAP) was performed to assess liver stiffness and steatosis stage.

NCT ID: NCT05874336 Completed - NASH Clinical Trials

An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of Aramchol

Start date: June 17, 2020
Phase: Phase 1
Study type: Interventional

A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects

NCT ID: NCT05804305 Completed - NASH Clinical Trials

Misoprostol for NASH

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.

NCT ID: NCT05560607 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease

Start date: August 12, 2022
Phase: Phase 1
Study type: Interventional

This is a two-part study. In Part A, eligible participants will undergo a baseline diagnostic liver biopsy to determine non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) and fibrosis stage, but will not receive study intervention. In Part B, participants with histologically confirmed NAFLD or non-alcoholic steatohepatitis (NASH) will receive study intervention.

NCT ID: NCT05383456 Completed - HIV Clinical Trials

The Visceral Adiposity Measurement and Observation Study

VAMOS
Start date: April 18, 2022
Phase:
Study type: Observational

The Visceral Adiposity Measurement and Observation Study

NCT ID: NCT05193916 Completed - NASH Clinical Trials

A Phase II Clinical Trial of Chiglitazar for NASH

Start date: March 21, 2022
Phase: Phase 2
Study type: Interventional

The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).

NCT ID: NCT05015491 Completed - Weight Loss Clinical Trials

Effects of Online App Weight Loss Programs on Liver Health in Obese Adults

Start date: August 9, 2021
Phase: N/A
Study type: Interventional

The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.

NCT ID: NCT04048135 Completed - NASH Clinical Trials

A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

Start date: July 29, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled. Part 2: This is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven NASH (NAS ≥4, fibrosis stage F2 or F3).

NCT ID: NCT04006145 Completed - NAFLD Clinical Trials

A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH

Start date: June 6, 2019
Phase: Phase 2
Study type: Interventional

Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or NASH (nonalcoholic steatohepatitis)

NCT ID: NCT03207425 Completed - NASH Clinical Trials

A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers

Start date: June 14, 2017
Phase: Phase 1
Study type: Interventional

This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.