Study Stopped
Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable
Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)
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)
1 other identifier
interventional
9
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2019
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedStudy Start
First participant enrolled
January 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJuly 11, 2019
July 1, 2019
3 months
September 5, 2018
July 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
Summary of treatment emergent adverse events coded using MedDRA
12 weeks
Secondary Outcomes (3)
Evaluation of Pharmacokinetics - PK
12 weeks
Evaluation of Pharmacodynamics - Labs
12 weeks
Evaluation of Phamacodynamics - MRI
12 weeks
Study Arms (3)
High-dose SGM-1019
EXPERIMENTALLow-dose SGM-1019
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female
- Age 18 to 75 years, inclusive
- Elevated ALT
- F1-F3 NASH
- BMI ≥ 25
You may not qualify if:
- Use of prohibited medication/supplements
- Poorly controlled type 2 diabetes
- Hepatic decompensation
- Chronic liver disease
- Planned surgeries/procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Genomelead
Study Sites (10)
Second Genome Clinical Site 405
Chandler, Arizona, 85224, United States
Second Genome Clinical Site 406
Tucson, Arizona, 85712, United States
Second Genome Clinical Site 403
Panorama City, California, 91402, United States
Second Genome Clinical Site 409
Lakewood Rch, Florida, 34211, United States
Second Genome Clinical Site 410
Flowood, Mississippi, 39232, United States
Second Genome Clinical Site 404
Kansas City, Missouri, 64131, United States
Second Genome Clinical Site 408
Fayetteville, North Carolina, 28304, United States
Second Genome Clinical Site 407
Clarksville, Tennessee, 37040, United States
Second Genome Clinical Site 402
Austin, Texas, 78746, United States
Second Genome Clinical Site 401
San Antonio, Texas, 78220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Matthew W McClure, M.D.
Second Genome
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2018
First Posted
September 18, 2018
Study Start
January 18, 2019
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
July 11, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share