Trial | NCT03676231  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    SGM-1019 ...

  • Study Participants

    9
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.
Study Started
Jan 18
2019
Primary Completion
May 01
2019
Study Completion
May 01
2019
Last Update
Jul 11
2019

Drug SGM-1019

Active

Drug Placebo

Inactive

High-dose SGM-1019 Experimental

Low-dose SGM-1019 Experimental

Placebo Placebo Comparator

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
No Results Posted