Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

• Status: Recruiting
• Trial end date: 2023-05-04
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor & licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Licogliflozin

Criteria

Inclusion Criteria:

Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:

1. NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and

2. Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

Exclusion Criteria:

• Type 1 diabetes mellitus

• Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at screening

• HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas

• Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:

• Platelet count < LLN (see Central laboratory manual).

• Serum albumin < LLN (see Central laboratory manual).

• International Normalized Ratio (INR) > ULN (see Central laboratory manual).

• ALT or AST > 5× ULN (confirmed by 2 values during screening).

• Total bilirubin > ULN (see Central laboratory manual) (confirmed by 2 values during screening), including Gilbert's syndrome.

• Alkaline phosphatase > 300 IU/L (confirmed by 2 values during screening).

• History of esophageal varices, ascites or hepatic encephalopathy

• Splenomegaly

• MELD score >12