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Last Updated: September 22, 2020

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CLINICAL TRIALS PROFILE FOR GS-4997

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Clinical Trials for GS-4997

Trial ID Title Status Sponsor Phase Summary
NCT02177786 Efficacy, Safety, and Tolerability of GS-4997 in Participants With Diabetic Kidney Disease Completed Gilead Sciences Phase 2 This study will evaluate the efficacy, safety, and tolerability of GS-4997 in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of GS-4997 (2 mg, 6 mg, or 18 mg) or matching placebo.
NCT02234141 Selonsertib in Adults With Pulmonary Arterial Hypertension Completed Gilead Sciences Phase 2 This study will compare the efficacy, safety, and tolerability of three doses of selonsertib (GS-4997) to placebo in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period.
NCT02466516 Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3 Completed Gilead Sciences Phase 2 This study will evaluate the safety and tolerability of GS-4997 alone or in combination with Simtuzumab (SIM) in adults with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.
NCT02509624 Pharmacokinetics of GS-4997 in Adults With Normal and Impaired Hepatic Function Completed Gilead Sciences Phase 1 This study will evaluate the pharmacokinetics (PK), safety, and tolerability of GS-4997 in adults with impaired hepatic function relative to matched, healthy controls. Each participant in the control group will be matched to a participant with impaired hepatic function by age (± 10 years), gender, and body mass index (± 20%).
NCT02781584 Safety, Tolerability, and Efficacy of GS-4997, GS-0976, and GS-9674 in Adults With Hepatic Steatosis and Elevated Liver Stiffness Recruiting Gilead Sciences Phase 2 The primary objective of this study is to evaluate the safety and tolerability of GS-4997, GS-0976, and GS-9674 in adults with hepatic steatosis and elevated liver stiffness.
NCT02854631 GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH) Recruiting Gilead Sciences Phase 2 The primary objective of this study is to evaluate the safety and tolerability of GS-4997 in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for GS-4997

Condition Name

Condition Name for
Intervention Trials
Diabetic Kidney Disease 2
Nonalcoholic Steatohepatitis 2
Alcoholic Hepatitis (AH) 1
Severe Alcoholic Hepatitis 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Non-alcoholic Fatty Liver Disease 4
Fatty Liver 4
Liver Diseases 2
Diabetic Nephropathies 2
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Clinical Trial Locations for GS-4997

Trials by Country

Trials by Country for
Location Trials
United States 124
Canada 12
Germany 2
Australia 2
United Kingdom 2
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Trials by US State

Trials by US State for
Location Trials
Texas 9
California 7
Virginia 6
Florida 6
Missouri 5
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Clinical Trial Progress for GS-4997

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 2
Phase 2 5
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 4
Recruiting 4
Withdrawn 1
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Clinical Trial Sponsors for GS-4997

Sponsor Name

Sponsor Name for
Sponsor Trials
Gilead Sciences 8
HepQuant, LLC 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 9
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