| Primary | Percent Change From Baseline in LDL-C at Day 28 | | Full Analysis Set (FAS): All enrolled participants who received at least 1 dose of study drug and had a valid post-baseline efficacy assessment, for a given dose level. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, day 28 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | | Title | Denominators | Categories |
|---|
| | |
| | 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 |
|---|
| | Mixed Models Analysis | | 0.0041 | Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used. | | | | | | | | | | | | | Other | | |
|
| Primary | Percent Change From Baseline in LDL-C at Day 56 | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, day 56 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Primary | Percent Change From Baseline in LDL-C at Day 84 | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, day 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting LDL-C | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Non-HDL-C | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Non-HDL-C | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Total Cholesterol (TC) | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Total Cholesterol (TC) | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Triglycerides (TG) | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Triglycerides (TG) | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting HDL-C | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting HDL-C | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting VLDL-C | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting VLDL-C | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting LDL-C as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Change From Baseline in Fasting LDL-C as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Percent Change From Baseline in Fasting Non-HDL-C as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Change From Baseline in Fasting Non-HDL-C as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Percent Change From Baseline in Fasting VLDL-C as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Change From Baseline in Fasting VLDL-C as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Percent Change From Baseline in Fasting HDL-C as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Change From Baseline in Fasting HDL-C as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Percent Change From Baseline in Fasting TC as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Change From Baseline in Fasting TC as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Percent Change From Baseline in Fasting TG as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Change From Baseline in Fasting TG as Per Receptor Mutation Status | Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure. | FAS Population. Here, number analyzed signifies those participants who were evaluable at each specified time point. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Number of Participants Achieving LDL-C Reduction of ≥15% | | | Posted | | Count of Participants | | Participants | No | Days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Number of Participants Achieving LDL-C Reduction of ≥20% | | | Posted | | Count of Participants | | Participants | No | Days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Number of Participants Achieving LDL-C Reduction of ≥25% | | | Posted | | Count of Participants | | Participants | No | Days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Number of Participants Achieving LDL-C Reduction of ≥30% | | | Posted | | Count of Participants | | Participants | No | Days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L) | | | Posted | | Count of Participants | | Participants | No | Days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) | | | Posted | | Least Squares Mean | Standard Error | mg/L | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fibrinogen | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fibrinogen | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Lipoprotein(a) | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Lipoprotein(a) | | | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein B | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Apolipoprotein B | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein A-I | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Apolipoprotein A-I | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein A-II | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Apolipoprotein A-II | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein C-II | | FAS Population. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure only. | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Change From Baseline in Fasting Apolipoprotein C-II | | FAS Population. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure only. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein C-III | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Apolipoprotein C-III | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein E | | | Posted | | Least Squares Mean | Standard Error | Percent Change | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |
| Secondary | Change From Baseline in Fasting Apolipoprotein E | | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, days 28, 56 and 84 | | | | ID | Title | Description |
|---|
| OG000 | Gemcabene | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 mg of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. |
| | |