Trial · NCT02944383
A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia
NCT02944383, Phase 2, Completed, NeuroBo Pharmaceuticals Inc.; results first posted 2020-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia. Trials, record NCT02944383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02944383
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia
- NCT number
- NCT02944383
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.
- Conditions
- Severe Hypertriglyceridemia, Mixed Dyslipidaemia
- Interventions
- Gemcabene, Placebo
- First posted
- 2016-10-25
- Last updated
- 2020-06-25
- Results first posted
- 2020-06-25
Source ClinicalTrials.gov
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | Baseline, EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using last observation carried forward (LOCF). |
| Secondary | Percent Change From Baseline in Fasting Serum TG | Baseline, Weeks 2, 6, 10 and 12 | |
| Secondary | Change From Baseline in Fasting Serum TG | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF. |
| Secondary | Percent Change From Baseline in TC | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF. |
| Secondary | Change From Baseline in TC | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF. |
| Secondary | Percent Change From Baseline in Non-HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF. |
| Secondary | Change From Baseline in Non-HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF. |
| Secondary | Percent Change From Baseline in VLDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF. |
| Secondary | Change From Baseline in VLDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF. |
| Secondary | Percent Change From Baseline in HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF. |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 registered outcomesOutcomes50
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | Baseline, EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. | Percent Change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Fasting Serum TG | Baseline, Weeks 2, 6, 10 and 12 | FAS Population. Missing values were imputed by LOCF. | Percent Change | MEDIAN |
| SECONDARY | Change From Baseline in Fasting Serum TG | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. | mg/dL | MEDIAN |
| SECONDARY | Percent Change From Baseline in TC | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. | Percent Change | MEDIAN |
| SECONDARY | Change From Baseline in TC | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. | mg/dL | MEDIAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. | Percent Change | MEDIAN |
| SECONDARY | Change From Baseline in Non-HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. | mg/dL | MEDIAN |
| SECONDARY | Percent Change From Baseline in VLDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only. | Percent Change | MEDIAN |
| SECONDARY | Change From Baseline in VLDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only. | mg/dL | MEDIAN |
| SECONDARY | Percent Change From Baseline in HDL-C | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | FAS Population. Missing values were imputed by LOCF. | Percent Change | MEDIAN |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 outcomesResults by group477
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | Gemcabene 600 mg | -47.32 | Inter-Quartile Range -59.58 to -30.93 | Percent Change | |
| Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | Gemcabene 300 mg | -32.95 | Inter-Quartile Range -48.53 to -12.21 | Percent Change | |
| Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | Placebo | -27.30 | Inter-Quartile Range -41.90 to 10.12 | Percent Change | |
| Percent Change From Baseline in Fasting Serum TG | Gemcabene 600 mg | Week 2 | -27.46 | Inter-Quartile Range -49.03 to -14.03 | Percent Change |
| Percent Change From Baseline in Fasting Serum TG | Gemcabene 300 mg | Week 2 | -27.10 | Inter-Quartile Range -46.77 to 2.24 | Percent Change |
| Percent Change From Baseline in Fasting Serum TG | Placebo | Week 2 | -27.07 | Inter-Quartile Range -37.53 to 11.01 | Percent Change |
| Percent Change From Baseline in Fasting Serum TG | Gemcabene 600 mg | Week 6 | -38.63 | Inter-Quartile Range -50.24 to -18.99 | Percent Change |
| Percent Change From Baseline in Fasting Serum TG | Gemcabene 300 mg | Week 6 | -25.11 | Inter-Quartile Range -46.46 to -5.47 | Percent Change |
| Percent Change From Baseline in Fasting Serum TG | Placebo | Week 6 | -22.18 | Inter-Quartile Range -41.48 to -5.17 | Percent Change |
| Percent Change From Baseline in Fasting Serum TG | Gemcabene 600 mg | Week 10 | -49.90 | Inter-Quartile Range -58.32 to -25.53 | Percent Change |
1 to 10 of 477Source ClinicalTrials.gov
See all 477 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcabene 600 mg | 30 | |
| Overall Study | STARTED | Gemcabene 300 mg | 30 | |
| Overall Study | STARTED | Placebo | 31 | |
| Overall Study | COMPLETED | Gemcabene 600 mg | 29 | |
| Overall Study | COMPLETED | Gemcabene 300 mg | 30 | |
| Overall Study | COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | Gemcabene 600 mg | 1 | |
| Overall Study | NOT COMPLETED | Gemcabene 300 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events255
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 | Ear pain | Ear and labyrinth disorders | Gemcabene 600 mg | 0 | 30 | |
| other | Ear pain | Ear and labyrinth disorders | Gemcabene 300 mg | 0 | 30 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 1 | 31 | |
| other | Cataract | Eye disorders | Gemcabene 600 mg | 1 | 30 | |
| other | Cataract | Eye disorders | Gemcabene 300 mg | 0 | 30 | |
| other | Cataract | Eye disorders | Placebo | 0 | 31 | |
| other | Dry eye | Eye disorders | Gemcabene 600 mg | 0 | 30 | |
| other | Dry eye | Eye disorders | Gemcabene 300 mg | 1 | 30 | |
| other | Dry eye | Eye disorders | Placebo | 0 | 31 | |
| other | Visual acuity reduced | Eye disorders | Gemcabene 600 mg | 0 | 30 |
1 to 10 of 255Source ClinicalTrials.gov
See all 255 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcabene 600 mg | 0 | 30 |
| Total, all-cause mortality | Gemcabene 300 mg | 0 | 30 |
| Total, all-cause mortality | Placebo | 0 | 31 |
| Total, other adverse events | Gemcabene 600 mg | 16 | 30 |
| Total, other adverse events | Gemcabene 300 mg | 14 | 30 |
| Total, other adverse events | Placebo | 20 | 31 |
| Total, serious adverse events | Gemcabene 600 mg | 0 | 30 |
| Total, serious adverse events | Gemcabene 300 mg | 0 | 30 |
| Total, serious adverse events | Placebo | 1 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02944383
GET https://conductscience.org/api/trials/v1/NCT02944383/registered?page=2