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

Primary Purpose

Nonalcoholic Steatohepatitis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SGM-1019
Placebo
Sponsored by
Second Genome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Genome Clinical Site 405
  • Second Genome Clinical Site 406
  • Second Genome Clinical Site 403
  • Second Genome Clinical Site 409
  • Second Genome Clinical Site 410
  • Second Genome Clinical Site 404
  • Second Genome Clinical Site 408
  • Second Genome Clinical Site 407
  • Second Genome Clinical Site 402
  • Second Genome Clinical Site 401

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High-dose SGM-1019

Low-dose SGM-1019

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
Summary of treatment emergent adverse events coded using MedDRA

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2018
Last Updated
July 9, 2019
Sponsor
Second Genome
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1. Study Identification

Unique Protocol Identification Number
NCT03676231
Brief Title
Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Genome

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-dose SGM-1019
Arm Type
Experimental
Arm Title
Low-dose SGM-1019
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SGM-1019
Intervention Description
Active
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive
Primary Outcome Measure Information:
Title
Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
Description
Summary of treatment emergent adverse events coded using MedDRA
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Evaluation of Pharmacokinetics - PK
Description
Peak plasma concentration of SGM-1019 as measured by Cmax
Time Frame
12 weeks
Title
Evaluation of Pharmacodynamics - Labs
Description
Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin.
Time Frame
12 weeks
Title
Evaluation of Phamacodynamics - MRI
Description
Evaluation of MRI parameters for assessment of liver fat, fibroinflammation, and stiffness.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew W McClure, M.D.
Organizational Affiliation
Second Genome
Official's Role
Study Director
Facility Information:
Facility Name
Second Genome Clinical Site 405
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Second Genome Clinical Site 406
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Second Genome Clinical Site 403
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Second Genome Clinical Site 409
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Second Genome Clinical Site 410
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Second Genome Clinical Site 404
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Second Genome Clinical Site 408
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Second Genome Clinical Site 407
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Facility Name
Second Genome Clinical Site 402
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Second Genome Clinical Site 401
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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