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Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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)

NCT03676231•Second Genome

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (10)

Second Genome Clinical Site 405

Chandler, Arizona, United States

Second Genome Clinical Site 406

Tucson, Arizona, United States

Second Genome Clinical Site 403

Panorama City, California, United States

Second Genome Clinical Site 409

Lakewood Rch, Florida, United States

Second Genome Clinical Site 410

Flowood, Mississippi, United States

Second Genome Clinical Site 404

Kansas City, Missouri, United States

Second Genome Clinical Site 408

Fayetteville, North Carolina, United States

Second Genome Clinical Site 407

Clarksville, Tennessee, United States

Second Genome Clinical Site 402

Austin, Texas, United States

Second Genome Clinical Site 401

San Antonio, Texas, United States

Key Dates

Start Date

January 18, 2019

Primary Completion Date

May 1, 2019

Completion Date

May 1, 2019

Last Updated

July 11, 2019

Enrollment

ACTUAL participants

Conditions

Nonalcoholic Steatohepatitis

Interventions

SGM-1019

DRUG

Placebo

DRUG

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

NCT02815891

Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis

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RECRUITINGNA

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

NCT03587831

NASH - Nonalcoholic Steatohepatitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

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Hepatic Energy Fluxes in NASH and NAS Patients

Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis

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