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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Non-Alcoholic Steatohepatitis (NASH)

Treatments: Drug: SEL; Biological: SIM

Study type: Interventional

Funder types: Industry

Identifiers

NCT02466516

GS-US-384-1497

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 5 patient groups

SEL 6 mg

Experimental group

Description:

Selonsertib (SEL) 6 mg for 24 weeks.

Treatment:

Drug: SEL

SEL 18 mg

Experimental group

Description:

SEL 18 mg for 24 weeks.

Treatment:

Drug: SEL

SEL 6 mg+SIM 125 mg

Experimental group

Description:

SEL 6 mg plus SIM 125 mg for 24 weeks.

Treatment:

Biological: SIM

Drug: SEL

SEL 18 mg+SIM 125 mg

Experimental group

Description:

SEL 18 mg plus SIM 125 mg for 24 weeks.

Treatment:

Biological: SIM

Drug: SEL

SIM 125 mg

Experimental group

Description:

SIM 125 mg for 24 weeks.

Treatment:

Biological: SIM