Overview

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