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

PHASE2TerminatedINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

December 30, 2019

Primary Completion Date

October 27, 2022

Study Completion Date

October 27, 2022

Conditions
Non Alcoholic Steatohepatitis (NASH)
Interventions
DRUG

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

DRUG

Licogliflozin

30mg tablet of licoglifozin taken orally every day

OTHER

Placebo

licogliflozin placebo + tropifexor placebo

Trial Locations (80)

1413

Novartis Investigative Site, Sofia

1784

Novartis Investigative Site, Sofia

2800

Novartis Investigative Site, Mechelen

6001

Novartis Investigative Site, Port Elizabeth

7531

Novartis Investigative Site, Cape Town

8200

Novartis Investigative Site, Aarhus N

10617

Novartis Investigative Site, Tallinn

10825

Novartis Investigative Site, Berlin

11030

Northwell Health, Manhasset

20089

Novartis Investigative Site, Rozzano

20122

Novartis Investigative Site, Milan

22381

Novartis Investigative Site, México

28009

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

28557

Diabetes And Endocrinology Conslt, Morehead City

28645

Clinical Trials Of America LLC, Lenoir

29485

Palmetto Clinical Research, Summerville

29605

Prisma Health, Greenville

29646

Digestive Disease Research, Greenwood

33166

Integrity Clinical Rsh LLC, Doral

33936

Galenus Group, Lehigh Acres

34010

Novartis Investigative Site, Istanbul

35128

Novartis Investigative Site, Padua

36305

Gut PC Digestive Health Specialist, Dothan

37076

Summit Medical Care, Hermitage

39216

Southern Therapy and Adv Res LLC, Jackson

44130

Novartis Investigative Site, Guadalajara

45147

Novartis Investigative Site, Essen

46635

Digestive Res Alliance of Michiana, South Bend

55131

Novartis Investigative Site, Mainz

63005

Clinical Research Professionals Inc, Chesterfield

64460

Novartis Investigative Site, Monterrey

70403

Novartis Investigative Site, Tainan City

74104

Options Health Research, Tulsa

75230

Dallas Diabetes and Endocrine Center, Dallas

76012

Texas Clinical Research Institute, Arlington

77479

Pioneer Research Solutions, Sugar Land

78215

American Research Corporation at Texas Liver Institute, San Antonio

78229

Clinical Trials of Texas, San Antonio

78240

Endeavor Clinical Trials, San Antonio

80756

Novartis Investigative Site, Kaohsiung City

87109

Southwest Gastroenterology Associates, Albuquerque

90057

Velocity Clinical Trials, Los Angeles

90127

Novartis Investigative Site, Palermo

91105

California Liver Research Institute, Pasadena

91405

San fernando Valley Health Institute, Van Nuys

92118

Southern California Research Center, Coronado

92123

Medical Associates Research Group, San Diego

93003

Island View Gastroenterology Associates, Ventura

110070

Novartis Investigative Site, New Delhi

110131

Novartis Investigative Site, Bogotá

119074

Novartis Investigative Site, Singapore

169608

Novartis Investigative Site, Singapore

199034

Novartis Investigative Site, Saint Petersburg

199226

Novartis Investigative Site, Saint Petersburg

443063

Novartis Investigative Site, Samara

630090

Novartis Investigative Site, Novosibirsk

2540364

Novartis Investigative Site, Viña del Mar

5110683

Novartis Investigative Site, Valdivia

33165-7574

Genoma Research Group Inc, Miami

C1073ABA

Novartis Investigative Site, San Juan Bautista

40110-160

Novartis Investigative Site, Salvador

90035-003

Novartis Investigative Site, Porto Alegre

04037-002

Novartis Investigative Site, São Paulo

05403-000

Novartis Investigative Site, São Paulo

H4A 3J1

Novartis Investigative Site, Montreal

050001

Novartis Investigative Site, Medellín

054047

Novartis Investigative Site, Rionegro

01307

Novartis Investigative Site, Dresden

760 8557

Novartis Investigative Site, Takamatsu

236-0004

Novartis Investigative Site, Yokohama

849-8501

Novartis Investigative Site, Saga

693 8501

Novartis Investigative Site, Izumo

06700

Novartis Investigative Site, Cuauhtémoc

00927

FDI Clinical Research, San Juan

07061

Novartis Investigative Site, Dongjak Gu

03080

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

AB25 2ZN

Novartis Investigative Site, Aberdeen

SE5 9RS

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY