Trial · NCT02442687
JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
NCT02442687, Phase 2, Completed, Manal Abdelmalek; results first posted 2019-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. JKB-121 for the Treatment of Nonalcoholic Steatohepatitis. Trials, record NCT02442687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02442687
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
- NCT number
- NCT02442687
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Manal Abdelmalek
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- JKB-121: 5 mg twice daily, JKB-121: 10 mg twice daily, Placebo
- First posted
- 2015-05-13
- Last updated
- 2019-01-07
- Results first posted
- 2019-01-07
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population) | Baseline to week 24 | |
| Primary | Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population) | Baseline to Week 12 | |
| Secondary | Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population) | Baseline to week 24 | |
| Secondary | Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population) | Baseline to week 12 | |
| Secondary | Time to Remission (in Weeks) | 24 weeks | 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. |
| Secondary | Change in BMI (Body Mass Index) | Baseline, week 24 | |
| Secondary | Change in Hemoglobin A1C | Baseline, week 24 | |
| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, week 24 | 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. |
| Secondary | Percent Change in Cholesterol | Baseline, week 24 | |
| Secondary | Percent Change in Triglycerides | Baseline, week 24 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population) | Baseline to week 24 | 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. | percentage of fat | LEAST_SQUARES_MEAN |
| PRIMARY | Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population) | Baseline to Week 12 | 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. | percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population) | Baseline to week 24 | 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. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population) | Baseline to week 12 | 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. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Remission (in Weeks) | 24 weeks | No subjects reached remission; analysis not performed. | ||
| SECONDARY | Change in BMI (Body Mass Index) | Baseline, week 24 | Only patients with non-missing baseline and the specified visit are included. | kg/m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Hemoglobin A1C | Baseline, week 24 | Only patients with non-missing baseline and the specified visit are included | percentage of HbA1C | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, week 24 | Only patients with non-missing baseline and the specified visit are included. | HOMA-IR index | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Cholesterol | Baseline, week 24 | percent change | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Change in Triglycerides | Baseline, week 24 | Only patients with non-missing baseline and the specified visit are included. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population) | JKB 121, 5 mg | 0.38 | 95% Confidence Interval -1.95 to 2.72 | percentage of fat | |
| Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population) | JKB-121: 10 mg | -0.44 | 95% Confidence Interval -3.63 to 2.74 | percentage of fat | |
| Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population) | Placebo | -3.09 | 95% Confidence Interval -5.28 to -0.91 | percentage of fat | |
| Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population) | JKB 121, 5 mg | -1.78 | 95% Confidence Interval -4.05 to 0.50 | percentage | |
| Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population) | JKB 121, 10 mg | -1.50 | 95% Confidence Interval -4.56 to 1.56 | percentage | |
| Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population) | Placebo | -2.74 | 95% Confidence Interval -4.78 to -0.70 | percentage | |
| Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population) | JKB 121, 5 mg | -6.7 | 95% Confidence Interval -25.2 to 11.8 | U/L | |
| Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population) | JKB 121, 10 mg | -1.3 | 95% Confidence Interval -25.6 to 23.0 | U/L | |
| Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population) | Placebo | -20.9 | 95% Confidence Interval -37.7 to -4.0 | U/L | |
| Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population) | JKB 121, 5 mg | -6.3 | 95% Confidence Interval -19.5 to 6.9 | U/L |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | JKB 5 mg BID | 21 | |
| Overall Study | STARTED | JKB 10 mg BID | 22 | |
| Overall Study | STARTED | Placebo BID | 22 | |
| Overall Study | COMPLETED | JKB 5 mg BID | 13 | |
| Overall Study | COMPLETED | JKB 10 mg BID | 11 | |
| Overall Study | COMPLETED | Placebo BID | 19 | |
| Overall Study | NOT COMPLETED | JKB 5 mg BID | 8 | |
| Overall Study | NOT COMPLETED | JKB 10 mg BID | 11 | |
| Overall Study | NOT COMPLETED | Placebo BID | 3 |
Source ClinicalTrials.gov
Adverse events51
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | JKB 5 mg Twice Daily | 5 | 21 | 5 |
| other | Nausea | Gastrointestinal disorders | Placebo Twice Daily | 5 | 22 | 5 |
| other | Nausea | Gastrointestinal disorders | JKB 121 10 mg Twice Daily | 8 | 22 | 8 |
| other | Diarrhea | Gastrointestinal disorders | JKB 5 mg Twice Daily | 4 | 21 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Placebo Twice Daily | 1 | 22 | 1 |
| other | Diarrhea | Gastrointestinal disorders | JKB 121 10 mg Twice Daily | 2 | 22 | 2 |
| other | Vomiting | Gastrointestinal disorders | JKB 5 mg Twice Daily | 1 | 21 | 1 |
| other | Vomiting | Gastrointestinal disorders | Placebo Twice Daily | 1 | 22 | 1 |
| other | Vomiting | Gastrointestinal disorders | JKB 121 10 mg Twice Daily | 2 | 22 | 2 |
| other | Fatigue | General disorders | JKB 5 mg Twice Daily | 1 | 21 | 1 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | JKB 5 mg Twice Daily | 0 | 21 |
| Total, all-cause mortality | Placebo Twice Daily | 0 | 22 |
| Total, all-cause mortality | JKB 121 10 mg Twice Daily | 0 | 22 |
| Total, other adverse events | JKB 5 mg Twice Daily | 18 | 21 |
| Total, other adverse events | Placebo Twice Daily | 15 | 22 |
| Total, other adverse events | JKB 121 10 mg Twice Daily | 19 | 22 |
| Total, serious adverse events | JKB 5 mg Twice Daily | 1 | 21 |
| Total, serious adverse events | Placebo Twice Daily | 0 | 22 |
| Total, serious adverse events | JKB 121 10 mg Twice Daily | 1 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36318027 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02442687
GET https://conductscience.org/api/trials/v1/NCT02442687/results?page=2