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Comparison · NCT03508687-deaths

Group 1: 300 mg Gemcabene Daily Week 1-24 vs Group 2: 600mg Gemcabene Daily Week 12-24: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Group 1: 300 mg Gemcabene Daily Week 1-24 vs Group 2: 600mg Gemcabene Daily Week 12-24: deaths from any cause. Trial comparisons, record NCT03508687-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03508687-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.658wilson
Risk in group 200.00000000000000005550.561wilson
Risk difference, group 1 minus group 20-0.5610.658newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Group 1: 300 mg Gemcabene Daily Week 1-24
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 300mg Gemcabene daily for 12 weeks total, starting at week 12.~300mg Gemcabene: 300mg Gemcabene
02EG000
Group 2Group 2: 600mg Gemcabene Daily Week 12-24
Patients will take Gemcabene 300mg daily for weeks 1-12. After 12 weeks, at visit T4, patients will be randomized 1:1 according to pre-generated randomization code to either of the following groups. Group 1: Gemcabene 300mg daily for weeks 12-24. Group 2: Gemcabene 600mg daily for weeks 12-24. This arm will receive 600mg Gemcabene daily for 12 weeks total, starting at week 12.~600mg Gemcabene: 600mg Gemcabene
03EG001

Harm

What it counts
Total, all-cause mortality
Time frame
28 weeks (24 week Treatment Period, and a follow-on safety assessment 4 weeks post final dose)

Source ClinicalTrials.gov

Trial

Title
Study of Gemcabene in Adults With FPLD
NCT number
NCT03508687
Phases
PHASE1, PHASE2
Conditions
Familial Partial Lipodystrophy, Hypertriglyceridemia, Fatty Liver, NASH - Nonalcoholic Steatohepatitis
Interventions
300mg Gemcabene, 600mg Gemcabene
Lead sponsor
Elif Oral
Results first posted
2020-08-17

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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