Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
NCT ID: NCT04065841
Last Updated: 2025-01-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
234 participants
INTERVENTIONAL
2019-12-30
2022-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Arm B: tropifexor monotherapy
Tropifexor monotherapy arm: tropifexor 140 mcg capsule (+ placebo matching licogliflozin tablet), once daily orally
Tropifexor
100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day
Arm C: licogliflozin monotherapy
Licogliflozin monotherapy arm: licogliflozin 30 mg tablet (+ placebo matching tropifexor capsule), once daily orally
Licogliflozin
30mg tablet of licoglifozin taken orally every day
Arm D: Placebo
Placebo arm: placebo matching tropifexor capsule + placebo matching licogliflozin tablet, once daily
Placebo
licogliflozin placebo + tropifexor placebo
Arm A: combination therapy
Combination therapy arm: tropifexor 140 mcg capsule + licogliflozin 30 mg tablet, once daily orally
Tropifexor
100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day
Licogliflozin
30mg tablet of licoglifozin taken orally every day
Interventions
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Tropifexor
100mcg+30mcg+10mcg capsules of tropifexor taken orally every day until the 140 mcg capsule of tropifexor taken orally every day is produced, then patients will switch to the single 140mcg capsule taken orally every day
Licogliflozin
30mg tablet of licoglifozin taken orally every day
Placebo
licogliflozin placebo + tropifexor placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Gut PC Digestive Health Specialist
Dothan, Alabama, United States
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
Clinical Trials of Texas
San Antonio, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Pioneer Research Solutions
Sugar Land, Texas, United States
Novartis Investigative Site
San Juan Bautista, Buenos Aires, Argentina
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Mechelen, , Belgium
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Salvador, Estado de Bahia, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Montreal, Quebec, Canada
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Valdivia, Los Ríos Region, Chile
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Viña del Mar, Región de Valparaíso, Chile
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Medellín, Antioquia, Colombia
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Rionegro, Antioquia, Colombia
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Bogotá, , Colombia
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Aarhus N, , Denmark
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Tallinn, , Estonia
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Berlin, , Germany
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Dresden, , Germany
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Essen, , Germany
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Mainz, , Germany
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New Delhi, National Capital Territory of Delhi, India
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Milan, MI, Italy
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Rozzano, MI, Italy
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Palermo, PA, Italy
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Padua, PD, Italy
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Takamatsu, Kagawa-ken, Japan
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Yokohama, Kanagawa, Japan
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Saga, Saga-ken, Japan
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Izumo, Shimane, Japan
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Guadalajara, Jalisco, Mexico
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Cuauhtémoc, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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México, , Mexico
FDI Clinical Research
San Juan, , Puerto Rico
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Port Elizabeth, Eastern Cape, South Africa
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Cape Town, , South Africa
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Dongjak Gu, Seoul, South Korea
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Seoul, , South Korea
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Barcelona, Catalonia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Kaohsiung City, , Taiwan
Novartis Investigative Site
Tainan City, , Taiwan
Novartis Investigative Site
Istanbul, Topkapi, Turkey (Türkiye)
Novartis Investigative Site
Aberdeen, Grampian Region, United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-002324-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLJN452D12201C
Identifier Type: -
Identifier Source: org_study_id
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