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

July 9, 2019 updated by: Second Genome

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)

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Second Genome Clinical Site 405
      • Tucson, Arizona, United States, 85712
        • Second Genome Clinical Site 406
    • California
      • Panorama City, California, United States, 91402
        • Second Genome Clinical Site 403
    • Florida
      • Lakewood Ranch, Florida, United States, 34211
        • Second Genome Clinical Site 409
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Second Genome Clinical Site 410
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Second Genome Clinical Site 404
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Second Genome Clinical Site 408
    • Tennessee
      • Clarksville, Tennessee, United States, 37040
        • Second Genome Clinical Site 407
    • Texas
      • Austin, Texas, United States, 78746
        • Second Genome Clinical Site 402
      • San Antonio, Texas, United States, 78220
        • Second Genome Clinical Site 401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Inactive
Experimental: High-dose SGM-1019
Drug: SGM-1019
Active
Experimental: Low-dose SGM-1019
Drug: SGM-1019
Active

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
Time Frame: 12 weeks
Summary of treatment emergent adverse events coded using MedDRA
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Genome

Investigators

  • Study Director: Matthew W McClure, M.D., Second Genome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGM-1019-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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