NCT03962608

Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis

Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis ("NASH-Safety")

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yaqrit Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH. The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes. Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria. Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo). The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan. 70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

Detailed description

This is a multicentre, randomized, double blinded, placebo controlled trial to intended to evaluate safety and tolerability of oral administration of Yaq-001 therapy. 70 Non-Alcoholic Steatohepatitis patients will be randomized (1:1) to: * Standard medical treatment + Yaq-001 (8 g/ day) - n= 35 * Standard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) - n= 35 Study patients will be dosed daily with Yaq-001 (or an equivalent quantity of placebo) for 48 weeks. Assessment of DSMB will take place when 15 Yaq-001- and 15 placebo-treated patients have completed 12 weeks of dosing. Investigational centres specialized in the management of patients with Non-Alcoholic Steatohepatitis will participate in the study. For each patient, the study duration will be up to 54 weeks, including the screening (up to 45 days), treatment (48 weeks) and 7-day follow up period. The total study duration is estimated to be approximately 18 months from screening of first patient until study completion of the last patient. This project has received funding from the European Union's Horizon 2020 research and innovation programme.

Conditions

• Non-Alcoholic Steatohepatitis

Interventions

Type	Name	Description
DEVICE	Yaq-001	Study patients will be dosed daily with 8g of product Yaq-001 for a period of 48 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 54 weeks, including the screening (up to 45 days), treatment (48 weeks) and 7-day follow up period.
DEVICE	Placebo	Study patients will be dosed daily with a quantity of placebo equivalent to 8g of product Yaq-001 for a period of 48 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 54 weeks, including the screening (up to 45 days), treatment (48 weeks) and 7-day follow up period.

Timeline

• Start date: 2021-01-31
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2019-05-24
• Last updated: 2022-03-03

Locations

9 sites across 6 countries: France, Italy, Portugal, Spain, Switzerland, United Kingdom