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).

Clinical Trial Conditions for Cilofexor

Condition Name

Condition Name
Intervention	Trials
Nonalcoholic Steatohepatitis	3
Nonalcoholic Steatohepatitis (NASH)	3
Primary Sclerosing Cholangitis	3
Compensated Cirrhosis	1

Condition MeSH

Condition MeSH
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
Location	Trials
United States	128
Canada	14
Australia	9
Austria	5
New Zealand	4

Trials by US State

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

Clinical Trial Progress for Cilofexor

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	7
Active, not recruiting	1
Recruiting	1

Clinical Trial Sponsors for Cilofexor

Sponsor Name

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

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	12