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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03676231

Enrollment

Registered

2018-09-18

Start date

2019-01-18

Completion date

2019-05-01

Last updated

2019-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Steatohepatitis

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.

Interventions

DRUGSGM-1019

Active

DRUGPlacebo

Inactive

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Evaluation of Pharmacokinetics - PK	12 weeks	Peak plasma concentration of SGM-1019 as measured by Cmax
Evaluation of Pharmacodynamics - Labs	12 weeks	Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin.
Evaluation of Phamacodynamics - MRI	12 weeks	Evaluation of MRI parameters for assessment of liver fat, fibroinflammation, and stiffness.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026