Skip to main content
MedPathMedPath Home
Clinical Trials/NCT03676231
NCT03676231
Terminated
Phase 2

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)

Second Genome10 sites in 1 country9 target enrollmentJanuary 18, 2019
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsNonalcoholic Steatohepatitis
InterventionsSGM-1019Placebo
DrugsSGM-1019Placebo

Overview

Phase
Phase 2
Intervention
SGM-1019
Conditions
Nonalcoholic Steatohepatitis
Sponsor
Second Genome
Enrollment
9
Locations
10
Primary Endpoint
Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
Status
Terminated
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 18, 2019
End Date
May 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Male or female
  • •Age 18 to 75 years, inclusive
  • •Elevated ALT
  • •F1-F3 NASH

Exclusion Criteria

  • •Use of prohibited medication/supplements
  • •Poorly controlled type 2 diabetes
  • •Hepatic decompensation
  • •Chronic liver disease
  • •Planned surgeries/procedures

Arms & Interventions

High-dose SGM-1019

Intervention: SGM-1019

Low-dose SGM-1019

Intervention: SGM-1019

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events

Time Frame: 12 weeks

Summary of treatment emergent adverse events coded using MedDRA

Secondary Outcomes

  • Evaluation of Pharmacodynamics - Labs(12 weeks)
  • Evaluation of Pharmacokinetics - PK(12 weeks)
  • Evaluation of Phamacodynamics - MRI(12 weeks)

Study Sites (10)

Loading locations...

Similar Trials

Completed
Phase 2
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary SyndromeAcute Coronary Syndrome
NCT00548587Eisai Inc.600
Completed
Not Applicable
A Randomized Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Potential Effects of the Dietary Supplement Violet™ Molecular Iodine (I2) on Breast Health in Women With Cyclic Breast Discomfort and TendernessFibrocystic Breast Condition (FBC)
NCT02676336BioPharmX, Inc.31
Completed
Phase 2
A Study of PCSK9 Inhibitor AK102 in Patients With HypercholesterolemiaHypercholesterolemia
NCT04358432Akeso262
Completed
Phase 2
A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)Heterozygous Familial Hypercholesterolemia
NCT04173793Akeso109
Completed
Phase 3
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2Ulcerative Colitis
NCT05507216Abivax S.A.636