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

Phase 2TerminatedNCT03676231

Second Genome9 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Nonalcoholic Steatohepatitis

Interventions

SGM-1019DRUG

Active

PlaceboDRUG

Inactive

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (10)

Second Genome Clinical Site 405

Chandler, Arizona, United States

Second Genome Clinical Site 406

Tucson, Arizona, United States

Second Genome Clinical Site 403

Panorama City, California, United States

Outcomes

Primary Outcomes

Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events

Summary of treatment emergent adverse events coded using MedDRA

Time frame: 12 weeks

Secondary Outcomes

Evaluation of Pharmacokinetics - PK

Peak plasma concentration of SGM-1019 as measured by Cmax

Time frame: 12 weeks

Evaluation of Pharmacodynamics - Labs

Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin.

Time frame: 12 weeks

Evaluation of Phamacodynamics - MRI

Evaluation of MRI parameters for assessment of liver fat, fibroinflammation, and stiffness.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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