Phase 2 N=65 Randomized Quadruple-blind Treatment

JKB-121 for the Treatment of Nonalcoholic Steatohepatitis

Nonalcoholic Steatohepatitis

Bottom Line

View on ClinicalTrials.gov: NCT02442687 ↗

Enrolled (actual)

Serious AEs

3.1%

Results posted

Jan 2019

Primary outcome: Primary: Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population) — 0.38; -0.44; -3.09 percentage of fat — p=0.034

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: JKB-121: 5 mg twice daily (Drug); JKB-121: 10 mg twice daily (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Manal Abdelmalek
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population)	0.38; -0.44; -3.09	0.034 sig
PRIMARY Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population)	-1.78; -1.50; -2.74	0.5276
SECONDARY Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population)	-6.7; -1.3; -20.9	0.2591
SECONDARY Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population)	-6.3; -9.9; -21.7	0.0882
SECONDARY Time to Remission (in Weeks)	—	—
SECONDARY Change in BMI (Body Mass Index)	-0.18; 0.54; -0.63	—
SECONDARY Change in Hemoglobin A1C	0.07; 0.23; 0.45	—
SECONDARY Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	-1.013; -0.679; -0.404	—
SECONDARY Percent Change in Cholesterol	6.62; -2.55; 2.26	—
SECONDARY Percent Change in Triglycerides	18.12; 2.62; 3.78	—
SECONDARY Percent Change in Low Density Lipoprotein (LDL) Cholesterol	5.92; -4.79; 1.50	—
SECONDARY Percent Change in High Density Lipoprotein (HDL)	2.70; -0.80; 13.97	—
SECONDARY Mean Serum Aspartate Aminotransferase (AST)	45.7; 42.9; 81.0; 45.3; 47.1; 67.4	—
SECONDARY Mean Serum Alanine Aminotransferase (ALT)	65.8; 70.4; 95.0; 63.8; 77.4; 79.4	—
SECONDARY Mean Serum Gamma-glutamyl Transpeptidase (GGT)	68.4; 83.8; 165.0; 73.7; 74.6; 147.5	—
SECONDARY Number of Subjects With ALT in Normal Range at Week 24	5; 4; 7	—
SECONDARY Maximum Observed Concentrations (Cmax)	5.26; 14.33	—
SECONDARY Minimum Observed Concentration (Cmin)	0.349; 1.512	—
SECONDARY Area Under Concentration-time (AUC)	38.50; 71.24; 26.29; 46.55; 26.29; 50.44	—
SECONDARY Half-life	8.55; 6.95	—

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02442687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.