Study of SGM-1019 in Patients With Nonalcoholic Steatohep... | NCT03676231

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

NCT03676231

Sponsor

Second Genome

Status

Terminated

Last Update Posted

Jul 11, 2019Actual

Enrollment

9Actual

Phase

Phase 2

Conditions

Nonalcoholic Steatohepatitis

Interventions

SGM-1019
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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)

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable

Expanded Access Info

Start Date

Jan 18, 2019Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

May 1, 2019Actual

First Submitted Date

Sep 5, 2018

First Submission Date that Met QC Criteria

Sep 17, 2018

First Posted Date

Sep 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2019

Last Update Posted Date

Jul 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
High-dose SGM-1019	Experimental	Drug: SGM-1019
Low-dose SGM-1019	Experimental	Drug: SGM-1019
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGM-1019	Drug	Active	High-dose SGM-1019 Low-dose SGM-1019

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of Pharmacokinetics - PK	Peak plasma concentration of SGM-1019 as measured by Cmax	12 weeks
Evaluation of Pharmacodynamics - Labs	Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew W McClure, M.D.	Second Genome	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Genome Clinical Site 405		Chandler	Arizona	85224	United States
Second Genome Clinical Site 406

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided