Phase 2 N=72 Randomized Treatment

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

Non-Alcoholic Steatohepatitis (NASH)

Bottom Line

View on ClinicalTrials.gov: NCT02466516 ↗

Enrolled (actual)

Serious AEs

6.9%

Results posted

Jun 2019

Primary outcome: Primary: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality — 17; 15; 9; 9 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SEL (Drug); SIM (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	17; 15; 9; 9; 7; 2	—
PRIMARY Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events	1; 2; 0; 0; 0; 1	—

Summary

The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib [SEL]) 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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02466516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.