| Primary | Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) | 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). | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-47.32(-59.58 to -30.93)
- OG001-32.95(-48.53 to -12.21)
- OG002-27.30(-41.90 to 10.12)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Ranked ANCOVA | Randomized treatment group & randomized baseline statin (yes or no) are included as factors, & outcome (ranked) at baseline is included as covariate. | 0.0063 | | Median Difference (Net) | -19.02 | | | 2-Sided | 95 | -33.07 | -4.25 | | | Estimates generated from Hodges-Lehmann method. | | Superiority | | | |
|
| Secondary | Percent Change From Baseline in Fasting Serum TG | | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 2, 6, 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Fasting Serum TG | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in TC | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in TC | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Non-HDL-C | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in VLDL-C | 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. | FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in VLDL-C | 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. | FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in HDL-C | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in HDL-C | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B | 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. | FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Apolipoprotein B | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein A-I | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Apolipoprotein A-I | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein A-II | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Apolipoprotein A-II | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein C-II | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Apolipoprotein C-II | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein C-III | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Apolipoprotein C-III | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein E | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Apolipoprotein E | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in LDL-C | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in LDL-C | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in LDL-TG | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in LDL-TG | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in VLDL-TG | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in VLDL-TG | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in HDL-TG | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in HDL-TG | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein Size | Percent change from baseline in Particle size for VLDL, HDL and LDL were reported. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Change From Baseline in Lipoprotein Size | Change from baseline in Particle size for VLDL, HDL and LDL were reported. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | nm | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percent Change From Baseline in Lipoprotein Particle Number | Percent change from baseline in particle number for VLDL & chylomicron, LDL and IDL were reported. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Change From Baseline in Lipoprotein Particle Number | Change from baseline in particle number for VLDL & chylomicron, LDL and IDL were reported. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | nmol/L | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percent Change From Baseline in HDL Particle Number | | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Change From Baseline in HDL Particle Number | | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | umol/L | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percent Change From Baseline in High-sensitivity C-reactive Protein | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Change From Baseline in High-sensitivity C-reactive Protein | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percent Change From Baseline in Fibrinogen | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Change From Baseline in Fibrinogen | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percent Change From Baseline in Serum Amyloid A | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Change From Baseline in Serum Amyloid A | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | mg/L | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percent Change From Baseline in Adiponectin | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Week 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Adiponectin | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | μg/mL | | Baseline, Week 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percent Change From Baseline in Angiopoietin 4 | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Week 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Angiopoietin 4 | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | ng/mL | | Baseline, Week 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percent Change From Baseline in Interleukin-6 | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | Percent Change | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
| |
| Secondary | Change From Baseline in Interleukin-6 | 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. | FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified time point only. | Posted | | Median | Inter-Quartile Range | pg/mL | | Baseline, Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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| Secondary | Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) | 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. | FAS Population. Missing values were imputed by LOCF. | Posted | | Number | | Percentage of participants | | Weeks 10, 12 and EOS (average of week 10 and 12) | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene 600 mg | Participants received 600 mg of Gemcabene orally, once daily for 12 weeks. | | OG001 | Gemcabene 300 mg | Participants received 300 mg of Gemcabene orally, once daily for 12 weeks. | | OG002 | Placebo | Participants received matching placebo orally, once daily for 12 weeks. |
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