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JKB-121 for the Treatment of Nonalcoholic Steatohepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02442687
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Manal Abdelmalek, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nonalcoholic Steatohepatitis
Interventions Drug: JKB-121: 5 mg twice daily
Drug: JKB-121: 10 mg twice daily
Drug: Placebo
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title JKB 5 mg BID JKB 10 mg BID Placebo BID
Hide Arm/Group Description JKB 121, 5 mg by mouth twice daily JKB 121, 10 mg by mouth twice daily Identical appearing placebo by mouth twice daily
Period Title: Overall Study
Started 21 22 22
Completed 13 11 19
Not Completed 8 11 3
Arm/Group Title JKB 5 mg BID JKB 10 mg BID Placebo BID Total
Hide Arm/Group Description JKB 121, 5 mg twice daily JKB 121, 10 mg twice daily Identical appearing placebo Total of all reporting groups
Overall Number of Baseline Participants 21 22 22 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 22 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  90.5%
17
  77.3%
20
  90.9%
56
  86.2%
>=65 years
2
   9.5%
5
  22.7%
2
   9.1%
9
  13.8%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 22 participants 22 participants 65 participants
51  (11.5) 50.5  (12.9) 49.5  (10.5) 51  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 22 participants 65 participants
Female
12
  57.1%
15
  68.2%
17
  77.3%
44
  67.7%
Male
9
  42.9%
7
  31.8%
5
  22.7%
21
  32.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 22 participants 65 participants
Hispanic or Latino
6
  28.6%
4
  18.2%
5
  22.7%
15
  23.1%
Not Hispanic or Latino
15
  71.4%
18
  81.8%
17
  77.3%
50
  76.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 22 participants 65 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.5%
0
   0.0%
1
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.5%
1
   4.5%
2
   3.1%
White
21
 100.0%
20
  90.9%
21
  95.5%
62
  95.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 22 participants 22 participants 65 participants
21 22 22 65
Body Mass Index  
Median (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 21 participants 22 participants 22 participants 65 participants
40.0  (6.8) 34.1  (6.4) 35.4  (6.5) 35.2  (6.5)
1.Primary Outcome
Title Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population)
Hide Description [Not Specified]
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.
Arm/Group Title JKB 121, 5 mg JKB-121: 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 11 19
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of fat
0.38
(-1.95 to 2.72)
-0.44
(-3.63 to 2.74)
-3.09
(-5.28 to -0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JKB 121, 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments The p-value was not adjusted for multiple comparison. The threshold for statistical significance was <0.05.
Method ANCOVA
Comments Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection JKB-121: 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1731
Comments The p-value was not adjusted for multiple comparison. The threshold for statistical significance was <0.05.
Method ANCOVA
Comments Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.
2.Primary Outcome
Title Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population)
Hide Description [Not Specified]
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 16 11 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage
-1.78
(-4.05 to 0.50)
-1.50
(-4.56 to 1.56)
-2.74
(-4.78 to -0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JKB 121, 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5276
Comments The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.
Method ANCOVA
Comments The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection JKB 121, 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4968
Comments The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.
Method ANCOVA
Comments The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.
3.Secondary Outcome
Title Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population)
Hide Description [Not Specified]
Time Frame Baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 11 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: U/L
-6.7
(-25.2 to 11.8)
-1.3
(-25.6 to 23.0)
-20.9
(-37.7 to -4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JKB 121, 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2591
Comments The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.
Method ANCOVA
Comments Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection JKB 121, 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1806
Comments The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.
Method ANCOVA
Comments Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.
4.Secondary Outcome
Title Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population)
Hide Description [Not Specified]
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 11 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: U/L
-6.3
(-19.5 to 6.9)
-9.9
(-27.2 to 7.4)
-21.7
(-33.7 to -9.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection JKB 121, 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0882
Comments The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.
Method ANCOVA
Comments The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection JKB 121, 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2530
Comments The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.
Method ANCOVA
Comments The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.
5.Secondary Outcome
Title Time to Remission (in Weeks)
Hide Description Time to remission is the time in weeks from randomization to liver function remission, defined as two consecutive ALT values within normal range (<40 U/L) during the treatment period.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects reached remission; analysis not performed.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in BMI (Body Mass Index)
Hide Description [Not Specified]
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline and the specified visit are included.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 13 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kg/m^2
-0.18
(-0.81 to 0.44)
0.54
(-0.21 to 1.30)
-0.63
(-1.20 to -0.05)
7.Secondary Outcome
Title Change in Hemoglobin A1C
Hide Description [Not Specified]
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline and the specified visit are included
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 13 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of HbA1C
0.07
(-0.49 to 0.63)
0.23
(-0.44 to 0.91)
0.45
(-0.08 to 0.98)
8.Secondary Outcome
Title Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Hide Description HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Optimal Range: 1.0 (0.5–1.4). Lower values represent a better outcome.
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline and the specified visit are included.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 13 19
Least Squares Mean (95% Confidence Interval)
Unit of Measure: HOMA-IR index
-1.013
(-3.831 to 1.805)
-0.679
(-4.132 to 2.775)
-0.404
(-3.039 to 2.231)
9.Secondary Outcome
Title Percent Change in Cholesterol
Hide Description [Not Specified]
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 13 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
6.62
(-0.42 to 13.66)
-2.55
(-11.03 to 5.94)
2.26
(-4.18 to 8.70)
10.Secondary Outcome
Title Percent Change in Triglycerides
Hide Description [Not Specified]
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline and the specified visit are included.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 13 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
18.12
(0.94 to 35.30)
2.62
(-18.14 to 23.38)
3.78
(-11.96 to 19.52)
11.Secondary Outcome
Title Percent Change in Low Density Lipoprotein (LDL) Cholesterol
Hide Description [Not Specified]
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline and the specified visit are included.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 13 18
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
5.92
(-5.57 to 17.41)
-4.79
(-18.73 to 9.15)
1.50
(-9.58 to 12.57)
12.Secondary Outcome
Title Percent Change in High Density Lipoprotein (HDL)
Hide Description [Not Specified]
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline and the specified visit are included.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 17 13 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
2.70
(-7.01 to 12.41)
-0.80
(-12.54 to 10.94)
13.97
(5.09 to 22.86)
13.Secondary Outcome
Title Mean Serum Aspartate Aminotransferase (AST)
Hide Description [Not Specified]
Time Frame weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 20 15 22
Mean (Standard Deviation)
Unit of Measure: U/L
Week 4 Number Analyzed 20 participants 14 participants 22 participants
45.7  (15.11) 42.9  (12.01) 81.0  (79.96)
Week 8 Number Analyzed 18 participants 15 participants 21 participants
45.3  (16.43) 47.1  (15.12) 67.4  (55.10)
Week 12 Number Analyzed 18 participants 13 participants 22 participants
47.6  (17.56) 44.2  (16.48) 49.7  (22.94)
Week 16 Number Analyzed 17 participants 13 participants 22 participants
42.9  (13.61) 47.5  (22.29) 51.1  (24.32)
Week 20 Number Analyzed 17 participants 13 participants 22 participants
50.1  (26.34) 46.4  (27.14) 54.0  (44.85)
Week 24 Number Analyzed 17 participants 13 participants 20 participants
49.4  (17.92) 49.5  (33.78) 47.4  (25.93)
14.Secondary Outcome
Title Mean Serum Alanine Aminotransferase (ALT)
Hide Description [Not Specified]
Time Frame weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 20 15 22
Mean (Standard Deviation)
Unit of Measure: U/L
Week 4 Number Analyzed 20 participants 15 participants 22 participants
65.8  (28.28) 70.4  (26.33) 95.0  (66.36)
Week 8 Number Analyzed 18 participants 15 participants 21 participants
63.8  (26.03) 77.4  (41.18) 79.4  (42.62)
Week 12 Number Analyzed 18 participants 13 participants 22 participants
67.9  (36.23) 65.3  (28.09) 69.8  (39.27)
Week 16 Number Analyzed 17 participants 13 participants 22 participants
61.5  (29.06) 69.5  (43.98) 68.7  (33.19)
Week 20 Number Analyzed 17 participants 13 participants 22 participants
61.1  (33.08) 63.8  (37.96) 70.7  (43.59)
Week 24 Number Analyzed 18 participants 13 participants 21 participants
67.3  (33.80) 68.2  (46.34) 67.6  (48.06)
15.Secondary Outcome
Title Mean Serum Gamma-glutamyl Transpeptidase (GGT)
Hide Description [Not Specified]
Time Frame weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 20 15 22
Mean (Standard Deviation)
Unit of Measure: U/L
Week 4 Number Analyzed 20 participants 15 participants 22 participants
68.4  (38.07) 83.8  (48.85) 165.0  (149.38)
Week 8 Number Analyzed 18 participants 15 participants 21 participants
73.7  (48.74) 74.6  (35.02) 147.5  (123.42)
Week 12 Number Analyzed 18 participants 13 participants 22 participants
79.2  (58.32) 74.3  (36.99) 133.8  (115.93)
Week 16 Number Analyzed 17 participants 13 participants 22 participants
78.3  (54.85) 69.8  (33.49) 134.7  (139.93)
Week 20 Number Analyzed 17 participants 13 participants 22 participants
75.4  (52.80) 64.1  (30.65) 132.9  (144.28)
Week 24 Number Analyzed 17 participants 13 participants 20 participants
86.6  (79.47) 68.2  (30.79) 109.7  (92.10)
16.Secondary Outcome
Title Number of Subjects With ALT in Normal Range at Week 24
Hide Description Normal range is <40 U/L
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with an ALT result at the specified visit
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg Placebo
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Identical appearing placebo

Placebo

Overall Number of Participants Analyzed 18 13 21
Measure Type: Count of Participants
Unit of Measure: Participants
5
  27.8%
4
  30.8%
7
  33.3%
17.Secondary Outcome
Title Maximum Observed Concentrations (Cmax)
Hide Description [Not Specified]
Time Frame pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Substudy Population
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.26  (1.731) 14.33  (1.986)
18.Secondary Outcome
Title Minimum Observed Concentration (Cmin)
Hide Description [Not Specified]
Time Frame pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Substudy Population
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.349  (0.1595) 1.512  (1.0702)
19.Secondary Outcome
Title Area Under Concentration-time (AUC)
Hide Description [Not Specified]
Time Frame pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Substudy Population
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
time 0 to infinity 38.50  (13.578) 71.24  (16.562)
time 0 to time of last quantifiable concentration 26.29  (9.443) 46.55  (5.312)
time 0 to 12 hours 26.29  (9.443) 50.44  (5.388)
20.Secondary Outcome
Title Half-life
Hide Description [Not Specified]
Time Frame pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Substudy Population
Arm/Group Title JKB 121, 5 mg JKB 121, 10 mg
Hide Arm/Group Description:

JKB 121, 5 mg twice daily

JKB-121: 5 mg twice daily

JKB 121, 10 mg twice daily

JKB-121: 10 mg twice daily

Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: h
8.55  (1.439) 6.95  (2.670)
Time Frame 6 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title JKB 5 mg Twice Daily Placebo Twice Daily JKB 121 10 mg Twice Daily
Hide Arm/Group Description JKB 121, 5 mg twice daily Placebo, twice daily JKB 121, 10 mg twice daily
All-Cause Mortality
JKB 5 mg Twice Daily Placebo Twice Daily JKB 121 10 mg Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/22 (0.00%)      0/22 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
JKB 5 mg Twice Daily Placebo Twice Daily JKB 121 10 mg Twice Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      0/22 (0.00%)      1/22 (4.55%)    
Gastrointestinal disorders       
Pancreatitis  1 [1]  1/21 (4.76%)  1 0/22 (0.00%)  0 0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute on Chronic Hypoxemic Respiratory Failure  1 [2]  0/21 (0.00%)  0 0/22 (0.00%)  0 1/22 (4.55%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
[1]
Deemed by PI and Sponsor not be attributable to study drug
[2]
Deemed not attributable to study drub
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
JKB 5 mg Twice Daily Placebo Twice Daily JKB 121 10 mg Twice Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/21 (85.71%)      15/22 (68.18%)      19/22 (86.36%)    
Gastrointestinal disorders       
Nausea  1  5/21 (23.81%)  5 5/22 (22.73%)  5 8/22 (36.36%)  8
Diarrhea  1  4/21 (19.05%)  4 1/22 (4.55%)  1 2/22 (9.09%)  2
Vomiting  1  1/21 (4.76%)  1 1/22 (4.55%)  1 2/22 (9.09%)  2
General disorders       
Fatigue  1  1/21 (4.76%)  1 1/22 (4.55%)  1 2/22 (9.09%)  2
Injury, poisoning and procedural complications       
Injury  1  2/21 (9.52%)  2 2/22 (9.09%)  2 1/22 (4.55%)  1
Nervous system disorders       
Dizziness  1  3/21 (14.29%)  3 0/22 (0.00%)  0 8/22 (36.36%)  8
Psychiatric disorders       
Insomnia  1  2/21 (9.52%)  2 0/22 (0.00%)  0 2/22 (9.09%)  2
Abnormal dreams  1  1/21 (4.76%)  1 0/22 (0.00%)  0 1/22 (4.55%)  1
Renal and urinary disorders       
Urinary Tract Infection  1  1/21 (4.76%)  1 1/22 (4.55%)  1 2/22 (9.09%)  2
Reproductive system and breast disorders       
Nasopharynitis  1  1/21 (4.76%)  1 2/22 (9.09%)  2 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders       
Oralpharyngeal pain  1  2/21 (9.52%)  2 0/22 (0.00%)  0 0/22 (0.00%)  0
Cough  1  1/21 (4.76%)  1 1/22 (4.55%)  1 0/22 (0.00%)  0
Nasal Congetion  1  0/21 (0.00%)  0 1/22 (4.55%)  1 1/22 (4.55%)  1
Upper respiratory tract infection  1  0/21 (0.00%)  0 2/22 (9.09%)  2 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritis  1  1/21 (4.76%)  1 0/22 (0.00%)  0 0/22 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
This is a pilot study to assess safety and tolerability of JKB 121 in patients with biopsy-proven NASH. There The study was underpowered to detect rare events.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Manal F. Abdelmalek
Organization: Duke University
Phone: 919-684-8356
Responsible Party: Manal Abdelmalek, Duke University
ClinicalTrials.gov Identifier: NCT02442687     History of Changes
Other Study ID Numbers: Pro00062677
First Submitted: April 7, 2015
First Posted: May 13, 2015
Results First Submitted: August 24, 2018
Results First Posted: January 7, 2019
Last Update Posted: January 7, 2019