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

NCT ID: NCT03676231

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2019-05-01

Brief Summary

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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

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Conditions

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Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High-dose SGM-1019

Group Type EXPERIMENTAL

SGM-1019

Intervention Type DRUG

Active

Low-dose SGM-1019

Group Type EXPERIMENTAL

SGM-1019

Intervention Type DRUG

Active

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive

Interventions

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SGM-1019

Active

Intervention Type DRUG

Placebo

Inactive

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Genome

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew W McClure, M.D.

Role: STUDY_DIRECTOR

Second Genome

Locations

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Second Genome Clinical Site 405

Chandler, Arizona, United States

Site Status

Second Genome Clinical Site 406

Tucson, Arizona, United States

Site Status

Second Genome Clinical Site 403

Panorama City, California, United States

Site Status

Second Genome Clinical Site 409

Lakewood Rch, Florida, United States

Site Status

Second Genome Clinical Site 410

Flowood, Mississippi, United States

Site Status

Second Genome Clinical Site 404

Kansas City, Missouri, United States

Site Status

Second Genome Clinical Site 408

Fayetteville, North Carolina, United States

Site Status

Second Genome Clinical Site 407

Clarksville, Tennessee, United States

Site Status

Second Genome Clinical Site 402

Austin, Texas, United States

Site Status

Second Genome Clinical Site 401

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SGM-1019-102

Identifier Type: -

Identifier Source: org_study_id

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