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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non Alcoholic Steatohepatitis (NASH)

In brief

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.

Key facts

Study ID

NCT04065841

Run by

Novartis Pharmaceuticals

People needed

234

Starts

2019-12-30

Expected to finish

2022-10-27

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and
• Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria

You may not qualify if…

• 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

Where it is running

• Southern California Research Center — Coronado, California, United States
• Velocity Clinical Trials — Los Angeles, California, United States
• California Liver Research Institute — Pasadena, California, United States
• Medical Associates Research Group — San Diego, California, United States
• San fernando Valley Health Institute — Van Nuys, California, United States
• Island View Gastroenterology Associates — Ventura, California, United States
• Integrity Clinical Rsh LLC — Doral, Florida, United States
• Galenus Group — Lehigh Acres, Florida, United States
• Genoma Research Group Inc — Miami, Florida, United States
• Digestive Res Alliance of Michiana — South Bend, Indiana, United States
• Southern Therapy and Adv Res LLC — Jackson, Mississippi, United States
• Clinical Research Professionals Inc — Chesterfield, Missouri, United States
• Southwest Gastroenterology Associates — Albuquerque, New Mexico, United States
• Northwell Health — Manhasset, New York, United States
• Clinical Trials Of America LLC — Lenoir, North Carolina, United States
• Diabetes And Endocrinology Conslt — Morehead City, North Carolina, United States
• Options Health Research — Tulsa, Oklahoma, United States
• Prisma Health — Greenville, South Carolina, United States
• Digestive Disease Research — Greenwood, South Carolina, United States
• Palmetto Clinical Research — Summerville, South Carolina, United States
• Summit Medical Care — Hermitage, Tennessee, United States
• Texas Clinical Research Institute — Arlington, Texas, United States
• Dallas Diabetes and Endocrine Center — Dallas, Texas, United States
• American Research Corporation at Texas Liver Institute — San Antonio, Texas, United States
• Gut PC Digestive Health Specialist — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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