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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03676231
Recruitment Status : Terminated (Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable)
First Posted : September 18, 2018
Last Update Posted : July 11, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: SGM-1019 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 18, 2019
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: High-dose SGM-1019 Drug: SGM-1019

Experimental: Low-dose SGM-1019 Drug: SGM-1019

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events [ Time Frame: 12 weeks ]
    Summary of treatment emergent adverse events coded using MedDRA

Secondary Outcome Measures :
  1. Evaluation of Pharmacokinetics - PK [ Time Frame: 12 weeks ]
    Peak plasma concentration of SGM-1019 as measured by Cmax

  2. Evaluation of Pharmacodynamics - Labs [ Time Frame: 12 weeks ]
    Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin.

  3. Evaluation of Phamacodynamics - MRI [ Time Frame: 12 weeks ]
    Evaluation of MRI parameters for assessment of liver fat, fibroinflammation, and stiffness.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03676231

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United States, Arizona
Second Genome Clinical Site 405
Chandler, Arizona, United States, 85224
Second Genome Clinical Site 406
Tucson, Arizona, United States, 85712
United States, California
Second Genome Clinical Site 403
Panorama City, California, United States, 91402
United States, Florida
Second Genome Clinical Site 409
Lakewood Ranch, Florida, United States, 34211
United States, Mississippi
Second Genome Clinical Site 410
Flowood, Mississippi, United States, 39232
United States, Missouri
Second Genome Clinical Site 404
Kansas City, Missouri, United States, 64131
United States, North Carolina
Second Genome Clinical Site 408
Fayetteville, North Carolina, United States, 28304
United States, Tennessee
Second Genome Clinical Site 407
Clarksville, Tennessee, United States, 37040
United States, Texas
Second Genome Clinical Site 402
Austin, Texas, United States, 78746
Second Genome Clinical Site 401
San Antonio, Texas, United States, 78220
Sponsors and Collaborators
Second Genome
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Study Director: Matthew W McClure, M.D. Second Genome
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Responsible Party: Second Genome Identifier: NCT03676231    
Other Study ID Numbers: SGM-1019-102
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases