JKB-121 for the Treatment of Nonalcoholic Steatohepatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis

In brief

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

Key facts

Study ID

NCT02442687

Run by

Manal Abdelmalek

People needed

65

Starts

2015-08-01

Expected to finish

2017-09-24

Last updated by the study team

2019-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Provision of written informed consent
• Biopsy-proven NASH within 12 months or at screening
• ALT > 40 U/L for women and > 60 U/L for men at screening and at least once in the previous 12 months.
• HBA1C of ≤ 9.0

You may not qualify if…

• Any chronic liver disease other than NASH
• Cirrhosis, as assessed clinically or histologically
• Presence of vascular liver disease
• BMI ≤ 25 kg/m2
• Excessive alcohol use (> 20 g/day) within the past 2 years
• AST or ALT > 250 U/L.
• Type 1 diabetes mellitus
• Bariatric surgery in the past 5 years.
• Weight gain of > 5% in past 6 months or > 10% change in past 12 months.
• Contraindication to MRI
• Inadequate venous access
• HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or Hepatitis C virus (HCV) RNA positive.
• Receiving an elemental diet or parenteral nutrition
• Chronic pancreatitis or pancreatic insufficiency
• Any history of complications of cirrhosis
• Concurrent conditions:
• Inflammatory bowel disease
• Significant cardiac disease
• chronic infection or immune mediated disease
• Any malignant disease
• Prior solid organ transplant
• Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or the interpretation of the study data.
• Concurrent medications which may treat NASH
• HbA1C > 9.0%
• Pregnancy or breastfeeding.

Where it is running

• Digestive Disease Specialists of the Southeast — Dothan, Alabama, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Digestive Associates — Las Vegas, Nevada, United States
• Duke University — Durham, North Carolina, United States
• Digestive Disease Specialists — Cincinnati, Ohio, United States
• Brook Army Medical Center — Houston, Texas, United States
• University of Virginia Health Systems — Charlottesville, Virginia, United States
• Medical College of Virginia — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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