CLINICAL TRIALS PROFILE FOR CILOFEXOR

Clinical Trials for Cilofexor

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02654002 ↗	Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics	Completed	Gilead Sciences	Phase 1	This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants will receive either cilofexor or cilofexor placebo. Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative, blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose already evaluated. This study is partially blinded (no one is blinded on Day -1).
NCT02781584 ↗	Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)	Completed	Gilead Sciences	Phase 2	The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
NCT02808312 ↗	Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function	Completed	Gilead Sciences	Phase 1	The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
NCT02943447 ↗	Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis	Terminated	Gilead Sciences	Phase 2	The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).
NCT02943460 ↗	Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis	Completed	Gilead Sciences	Phase 2	The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).
NCT03449446 ↗	Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)	Completed	Gilead Sciences	Phase 2	The primary objectives of this study are: - To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH - To evaluate changes in liver fibrosis, without worsening of NASH
NCT03890120 ↗	Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis	Active, not recruiting	Gilead Sciences	Phase 3	The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

Clinical Trial Conditions for Cilofexor

Condition Name

Condition Name for
Intervention	Trials
Primary Sclerosing Cholangitis	3
Nonalcoholic Steatohepatitis	3
Nonalcoholic Steatohepatitis (NASH)	3
Primary Biliary Cholangitis	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Non-alcoholic Fatty Liver Disease	6
Fatty Liver	6
Cholangitis	5
Cholangitis, Sclerosing	4

Clinical Trial Locations for Cilofexor

Trials by Country

Trials by Country for
Location	Trials
United States	128
Canada	14
Australia	9
Austria	5
New Zealand	4

Trials by US State

Trials by US State for
Location	Trials
Texas	9
Florida	8
Tennessee	8
Arizona	8
California	8

Clinical Trial Progress for Cilofexor

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	6
Phase 1	3

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	7
Recruiting	1
Terminated	1

Clinical Trial Sponsors for Cilofexor

Sponsor Name

Sponsor Name for
Sponsor	Trials
Gilead Sciences	10
Novo Nordisk A/S	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	12