Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SGM-1019 Administered for 12 Weeks in Subjects With F1-F3 Nonalcoholic Steatohepatitis (NASH)

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.

Inclusion Criteria:

• Male or female
• Age 18 to 75 years, inclusive
• Elevated ALT
• F1-F3 NASH
• BMI ≥ 25

Exclusion Criteria:

• Use of prohibited medication/supplements
• Poorly controlled type 2 diabetes
• Hepatic decompensation
• Chronic liver disease
• Planned surgeries/procedures