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

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ClinicalTrials.gov 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
Sponsor:
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


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

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

Placebo Comparator: Placebo Drug: Placebo
Inactive




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.



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03676231


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

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Responsible Party: Second Genome
ClinicalTrials.gov Identifier: NCT03676231     History of Changes
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