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

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03676231
• Other study ID #: SGM-1019-102
• Status: Terminated
• Phase: Phase 2
• Start date: January 18, 2019
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2019
• Source: Second Genome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• SGM-1019
Active
• Placebo
Inactive

Locations

Country	Name	City	State
United States	Second Genome Clinical Site 402	Austin	Texas
United States	Second Genome Clinical Site 405	Chandler	Arizona
United States	Second Genome Clinical Site 407	Clarksville	Tennessee
United States	Second Genome Clinical Site 408	Fayetteville	North Carolina
United States	Second Genome Clinical Site 410	Flowood	Mississippi
United States	Second Genome Clinical Site 404	Kansas City	Missouri
United States	Second Genome Clinical Site 409	Lakewood Ranch	Florida
United States	Second Genome Clinical Site 403	Panorama City	California
United States	Second Genome Clinical Site 401	San Antonio	Texas
United States	Second Genome Clinical Site 406	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Second Genome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events	Summary of treatment emergent adverse events coded using MedDRA	12 weeks
Secondary	Evaluation of Pharmacokinetics - PK	Peak plasma concentration of SGM-1019 as measured by Cmax	12 weeks
Secondary	Evaluation of Pharmacodynamics - Labs	Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin.	12 weeks
Secondary	Evaluation of Phamacodynamics - MRI	Evaluation of MRI parameters for assessment of liver fat, fibroinflammation, and stiffness.	12 weeks