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

• Status: Terminated
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Genome

Criteria

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