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JKB-121 for the Treatment of Nonalcoholic Steatohepatitis

NCT02442687 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-01-07

Study results available
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Summary

To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis

Conditions

Interventions

DRUG

JKB-121: 5 mg twice daily

DRUG

JKB-121: 10 mg twice daily

DRUG

Placebo

Sponsors & Collaborators

  • Manal Abdelmalek

    lead OTHER

Principal Investigators

  • Manal F Abdelmalek, MD, MPH · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2017-09-24
Completion
2017-09-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442687 on ClinicalTrials.gov