Trial · NCT03508687
Study of Gemcabene in Adults With FPLD
NCT03508687, Phase 1, Phase 2, Completed, Elif Oral; results first posted 2020-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Gemcabene in Adults With FPLD. Trials, record NCT03508687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03508687
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Gemcabene in Adults With FPLD
- NCT number
- NCT03508687
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Elif Oral
- Conditions
- Familial Partial Lipodystrophy, Hypertriglyceridemia, Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- Interventions
- 300mg Gemcabene, 600mg Gemcabene
- First posted
- 2018-04-26
- Last updated
- 2020-08-17
- Results first posted
- 2020-08-17
- Limitations and caveats
- The expected number of study subjects (8), was not reached.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Fasting Serum Triglyceride (at 12 Weeks) | Baseline to week 12 | This is measured by percent change in fasting serum triglyceride from baseline to week 12 |
| Secondary | Change in Fasting Serum Triglycerides (Through 24 Weeks) | Baseline, week 6 and week 12, week 24 | This is measured by change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12 |
| Secondary | Percent Change in Fasting Serum Triglycerides (Through 24 Weeks) | Baseline, week 6 and week 12, week 24 | This is measured by percent change in fasting serum triglyceride from baseline to average of weeks 6 and 12, and week 24 and change in fasting serum triglyceride from baseline to week 12 |
| Secondary | Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) | Baseline, week 12, week 24 | This is measured by change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24 |
| Secondary | Percent Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) | Baseline, week 12, week 24 | This is measured by percent change in liver fat content using Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) from baseline to week 12 and week 24 |
| Secondary | Change in Liver Fibrosis | Baseline, Week 12, and Week 24 | This is measured by change in liver fibrosis using MR-elastography from baseline to week 12 and week 24 |
| Secondary | Percent Change in Liver Fibrosis | Baseline, Week 12, and Week 24 | This is measured by percent change in liver fibrosis using MR-elastography from baseline to week 12 and week 24 |
| Secondary | Change in NAS (Non-alcoholic Steatohepatitis) | Baseline to week 24 | This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease. |
| Secondary | Percent Change in NAS (Non-alcoholic Steatohepatitis) | Baseline to week 24 | This is measured by change in NAS via non-alcoholic fatty liver disease activity score. NAS is the unweighted sum of steatosis, lobular inflammation and hepatocyte ballooning from baseline to week 24. Total NAS scores can range from 0 to 8. The higher the NAS score, the more severe the liver disease. |
| Secondary | Change in Cholesterol | Baseline, week 6 and week 12, week 24 | This will be measured by change in total, HDL and LDL levels in mg/dL |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Fasting Serum Triglyceride (at 12 Weeks) | Baseline to week 12 | percent change | MEAN | |
| SECONDARY | Change in Fasting Serum Triglycerides (Through 24 Weeks) | Baseline, week 6 and week 12, week 24 | mg/dL | MEAN | |
| SECONDARY | Percent Change in Fasting Serum Triglycerides (Through 24 Weeks) | Baseline, week 6 and week 12, week 24 | percent change | MEAN | |
| SECONDARY | Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) | Baseline, week 12, week 24 | % PDFF | MEAN | |
| SECONDARY | Percent Change in Liver Fat Content as Measured by Magnetic Resonance Imaging - Protein Density Fat Fraction (MRI-PDFF) | Baseline, week 12, week 24 | percent change in liver fat | MEAN | |
| SECONDARY | Change in Liver Fibrosis | Baseline, Week 12, and Week 24 | Percentage of change in Preliminary Hepatic Fat-Fraction (PDFF) | kPA | MEAN |
| SECONDARY | Percent Change in Liver Fibrosis | Baseline, Week 12, and Week 24 | percent change in fibrosis | MEAN | |
| SECONDARY | Change in NAS (Non-alcoholic Steatohepatitis) | Baseline to week 24 | Liver biopsy was performed in two participants at baseline (1 subject in group-1 and another subject in group-2).~Paired liver biopsy was only available for the subject in group-1. | scores on a scale (NAFLD activity score) | MEAN |
| SECONDARY | Percent Change in NAS (Non-alcoholic Steatohepatitis) | Baseline to week 24 | percent change | MEAN | |
| SECONDARY | Change in Cholesterol | Baseline, week 6 and week 12, week 24 | mg/dL | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Fasting Serum Triglyceride (at 12 Weeks) | Group 1: 300 mg Gemcabene Daily Week 1-24 | -0.44 | Full Range -41.27 to 40.38 | percent change | |
| Change in Fasting Serum Triglyceride (at 12 Weeks) | Group 2: 600mg Gemcabene Daily Week 12-24 | -20.27 | Full Range -53.98 to 12.77 | percent change | |
| Change in Fasting Serum Triglycerides (Through 24 Weeks) | Group 1: 300 mg Gemcabene Daily Week 1-24 | Baseline to average of W6, W12, W24 | 9.25 | Full Range -68.50 to 87.00 | mg/dL |
| Change in Fasting Serum Triglycerides (Through 24 Weeks) | Group 2: 600mg Gemcabene Daily Week 12-24 | Baseline to average of W6, W12, W24 | -126.22 | Full Range -252.17 to -10.50 | mg/dL |
| Change in Fasting Serum Triglycerides (Through 24 Weeks) | Group 1: 300 mg Gemcabene Daily Week 1-24 | Baseline to W12 | -10.75 | Full Range -126.50 to 105.00 | mg/dL |
| Change in Fasting Serum Triglycerides (Through 24 Weeks) | Group 2: 600mg Gemcabene Daily Week 12-24 | Baseline to W12 | -189.33 | Full Range -305.00 to 32.50 | mg/dL |
| Percent Change in Fasting Serum Triglycerides (Through 24 Weeks) | Group 1: 300 mg Gemcabene Daily Week 12-24 | Baseline to average of W6, W12, and W24 | 5.56 | Full Range -22.35 to 33.46 | percent change |
| Percent Change in Fasting Serum Triglycerides (Through 24 Weeks) | Group 2: 600mg Gemcabene Daily Week 12-24 | Baseline to average of W6, W12, and W24 | -18.91 | Full Range -45.15 to -4.15 | percent change |
| Percent Change in Fasting Serum Triglycerides (Through 24 Weeks) | Group 1: 300 mg Gemcabene Daily Week 12-24 | Baseline to Week 12 | -0.44 | Full Range -41.27 to 40.38 | percent change |
| Percent Change in Fasting Serum Triglycerides (Through 24 Weeks) | Group 2: 600mg Gemcabene Daily Week 12-24 | Baseline to Week 12 | -19.91 | Full Range -52.91 to 12.77 | percent change |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: 300 mg Gemcabene Daily Week 1-24 | 2 | |
| Overall Study | STARTED | Group 2: 600mg Gemcabene Daily Week 12-24 | 3 | |
| Overall Study | COMPLETED | Group 1: 300 mg Gemcabene Daily Week 1-24 | 2 | |
| Overall Study | COMPLETED | Group 2: 600mg Gemcabene Daily Week 12-24 | 3 | |
| Overall Study | NOT COMPLETED | Group 1: 300 mg Gemcabene Daily Week 1-24 | 0 | |
| Overall Study | NOT COMPLETED | Group 2: 600mg Gemcabene Daily Week 12-24 | 0 |
Source ClinicalTrials.gov
Adverse events92
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 | Increase in liver fat | Hepatobiliary disorders | Group 1: 300 mg Gemcabene Daily Week 1-24 | 2 | 2 | 2 |
| other | Increase in liver fat | Hepatobiliary disorders | Group 2: 600mg Gemcabene Daily Week 12-24 | 1 | 3 | 1 |
| other | Upper Respiratory Infection | Infections and infestations | Group 1: 300 mg Gemcabene Daily Week 1-24 | 1 | 2 | 1 |
| other | Upper Respiratory Infection | Infections and infestations | Group 2: 600mg Gemcabene Daily Week 12-24 | 1 | 3 | 1 |
| other | Increased Muscle Pain | Musculoskeletal and connective tissue disorders | Group 1: 300 mg Gemcabene Daily Week 1-24 | 1 | 2 | 1 |
| other | Increased Muscle Pain | Musculoskeletal and connective tissue disorders | Group 2: 600mg Gemcabene Daily Week 12-24 | 0 | 3 | 0 |
| other | Arthritis of thumb | Musculoskeletal and connective tissue disorders | Group 1: 300 mg Gemcabene Daily Week 1-24 | 1 | 2 | 1 |
| other | Arthritis of thumb | Musculoskeletal and connective tissue disorders | Group 2: 600mg Gemcabene Daily Week 12-24 | 0 | 3 | 0 |
| other | Bloating | Gastrointestinal disorders | Group 1: 300 mg Gemcabene Daily Week 1-24 | 1 | 2 | 1 |
| other | Bloating | Gastrointestinal disorders | Group 2: 600mg Gemcabene Daily Week 12-24 | 0 | 3 | 0 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: 300 mg Gemcabene Daily Week 1-24 | 0 | 2 |
| Total, all-cause mortality | Group 2: 600mg Gemcabene Daily Week 12-24 | 0 | 3 |
| Total, other adverse events | Group 1: 300 mg Gemcabene Daily Week 1-24 | 2 | 2 |
| Total, other adverse events | Group 2: 600mg Gemcabene Daily Week 12-24 | 3 | 3 |
| Total, serious adverse events | Group 1: 300 mg Gemcabene Daily Week 1-24 | 0 | 2 |
| Total, serious adverse events | Group 2: 600mg Gemcabene Daily Week 12-24 | 1 | 3 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: 300 mg Gemcabene Daily Week 1-24 vs Group 2: 600mg Gemcabene Daily Week 12-24: deaths from any cause | Trial comparisons |
| Group 1: 300 mg Gemcabene Daily Week 1-24 vs Group 2: 600mg Gemcabene Daily Week 12-24: serious adverse events | Trial comparisons |
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/NCT03508687
GET https://conductscience.org/api/trials/v1/NCT03508687/results?page=2