Overview

This trial has been completed.

Condition non-alcoholic steatohepatitis (nash)
Treatments gs-4997, sim
Phase phase 2
Sponsor Gilead Sciences
Start date June 2015
End date October 2016
Trial size 72 participants
Trial identifier NCT02466516, GS-US-384-1497

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
GS-4997 6 mg for 24 weeks
gs-4997
GS-4997 tablets administered orally once daily
(Experimental)
GS-4997 18 mg for 24 weeks
gs-4997
GS-4997 tablets administered orally once daily
(Experimental)
GS-4997 6 mg plus SIM 125 mg for 24 weeks
gs-4997
GS-4997 tablets administered orally once daily
sim GS-6624
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
(Experimental)
GS-4997 18 mg plus SIM 125 mg for 24 weeks
gs-4997
GS-4997 tablets administered orally once daily
sim GS-6624
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
(Experimental)
SIM 125 mg for 24 weeks
sim GS-6624
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly

Primary Outcomes

Measure
Adverse event profile of GS-4997
time frame: Up to 28 weeks
Percentage of participants who prematurely discontinued study drug or study due to adverse events
time frame: Up to 28 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Key Inclusion Criteria: - Males and non-pregnant, non-lactating females - Evidence of NASH with fibrosis on biopsy Key Exclusion Criteria: - Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4) - Other causes of liver disease including viral hepatitis and alcoholic liver disease - Any history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding - History of liver transplantation - Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1 oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine, and a 1 oz/30 mL measure of 40% proof alcohol) Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

Official title A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.