CLINICAL TRIALS PROFILE FOR TROPIFEXOR

Clinical Trials for Tropifexor

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02516605 ↗	A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients	Completed	Novartis Pharmaceuticals	Phase 2	A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
NCT02855164 ↗	Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)	Terminated	Novartis Pharmaceuticals	Phase 2	The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH
NCT03517540 ↗	Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis	Completed	Allergan	Phase 2	The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
NCT03517540 ↗	Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis	Completed	Novartis Pharmaceuticals	Phase 2	The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
NCT03681457 ↗	Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects	Completed	Novartis Pharmaceuticals	Phase 1	The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.
NCT04065841 ↗	Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.	Recruiting	Novartis Pharmaceuticals	Phase 2	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
NCT04147195 ↗	Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)	Recruiting	Novartis Pharmaceuticals	Phase 2	This study will look at how different single and combination study treatments will work in adults with non-alcoholic fatty liver disease (NAFLD) who have features of non-alcoholic steatohepatitis (NASH). The study will see if the treatments are safe and see if they can improve NAFLD.

Clinical Trial Conditions for Tropifexor

Condition Name

Condition Name for
Intervention	Trials
Non-alcoholic Steatohepatitis	2
Non-alcoholic Steatohepatitis (NASH)	2
Non-alcoholic Fatty Liver Disease	2
Nonalcoholic Steatohepatitis	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Fatty Liver	5
Non-alcoholic Fatty Liver Disease	5
Liver Cirrhosis	3
Liver Diseases	3

Clinical Trial Locations for Tropifexor

Trials by Country

Trials by Country for
Location	Trials
United States	78
Italy	10
Spain	9
Japan	8
Canada	7

Trials by US State

Trials by US State for
Location	Trials
Texas	6
California	6
Florida	6
Tennessee	5
North Carolina	5

Clinical Trial Progress for Tropifexor

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	5
Phase 1	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	4
Recruiting	2
Terminated	1

Clinical Trial Sponsors for Tropifexor

Sponsor Name

Sponsor Name for
Sponsor	Trials
Novartis Pharmaceuticals	7
Allergan	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	8