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

Phase 2

Terminated

• Conditions: Nonalcoholic Steatohepatitis
• Interventions: Drug: SGM-1019; Drug: Placebo

• Registration Number: NCT03676231
• Lead Sponsor: Second Genome

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-18
• Study Start: 2019-01-18
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose SGM-1019	SGM-1019	-
Placebo	Placebo	-
Low-dose SGM-1019	SGM-1019	-

Primary Outcome Measures

Name	Time	Method
Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events	12 weeks	Summary of treatment emergent adverse events coded using MedDRA

Secondary Outcome Measures

Name	Time	Method
Evaluation of Pharmacodynamics - Labs	12 weeks	Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin.
Evaluation of Pharmacokinetics - PK	12 weeks	Peak plasma concentration of SGM-1019 as measured by Cmax
Evaluation of Phamacodynamics - MRI	12 weeks	Evaluation of MRI parameters for assessment of liver fat, fibroinflammation, and stiffness.

Trial Locations

Locations (10)

Second Genome Clinical Site 406; 🇺🇸 Tucson, Arizona, United States

Second Genome Clinical Site 403; 🇺🇸 Panorama City, California, United States

Second Genome Clinical Site 407; 🇺🇸 Clarksville, Tennessee, United States

Second Genome Clinical Site 402; 🇺🇸 Austin, Texas, United States

Second Genome Clinical Site 408; 🇺🇸 Fayetteville, North Carolina, United States

Second Genome Clinical Site 409; 🇺🇸 Lakewood Ranch, Florida, United States

Second Genome Clinical Site 410; 🇺🇸 Flowood, Mississippi, United States

Second Genome Clinical Site 405; 🇺🇸 Chandler, Arizona, United States

Second Genome Clinical Site 401; 🇺🇸 San Antonio, Texas, United States

Second Genome Clinical Site 404; 🇺🇸 Kansas City, Missouri, United States