Trial Outcomes & Findings for A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia (NCT NCT02944383)

Last Updated: 2020-06-25

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

91 participants

Primary outcome timeframe

Baseline, EOS (average of week 10 and 12)

Results posted on

2020-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcabene 600 mg Participants received 600 milligram (mg) Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg Participants received 300 mg Gemcabene orally, once daily for 12 weeks.	Placebo Participants received matching placebo orally, once daily for 12 weeks.
Overall Study STARTED	30	30	31
Overall Study COMPLETED	29	30	30
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcabene 600 mg Participants received 600 milligram (mg) Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg Participants received 300 mg Gemcabene orally, once daily for 12 weeks.	Placebo Participants received matching placebo orally, once daily for 12 weeks.
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

FAS Population. Here, number analyzed signifies participants with available data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.	Total n=91 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 9.10 • n=30 Participants	51.5 years STANDARD_DEVIATION 9.50 • n=30 Participants	54.6 years STANDARD_DEVIATION 12.06 • n=31 Participants	54.1 years STANDARD_DEVIATION 10.40 • n=91 Participants
Sex: Female, Male Female	5 Participants n=30 Participants	1 Participants n=30 Participants	12 Participants n=31 Participants	18 Participants n=91 Participants
Sex: Female, Male Male	25 Participants n=30 Participants	29 Participants n=30 Participants	19 Participants n=31 Participants	73 Participants n=91 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=30 Participants	13 Participants n=30 Participants	10 Participants n=31 Participants	35 Participants n=91 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=30 Participants	17 Participants n=30 Participants	21 Participants n=31 Participants	56 Participants n=91 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=31 Participants	0 Participants n=91 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=31 Participants	0 Participants n=91 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	1 Participants n=30 Participants	2 Participants n=31 Participants	3 Participants n=91 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=31 Participants	0 Participants n=91 Participants
Race (NIH/OMB) Black or African American	2 Participants n=30 Participants	0 Participants n=30 Participants	2 Participants n=31 Participants	4 Participants n=91 Participants
Race (NIH/OMB) White	28 Participants n=30 Participants	29 Participants n=30 Participants	25 Participants n=31 Participants	82 Participants n=91 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=31 Participants	0 Participants n=91 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	2 Participants n=31 Participants	2 Participants n=91 Participants
Triglycerides [TG]	637 Milligram per deciliter (mg/dL) n=30 Participants	641.17 Milligram per deciliter (mg/dL) n=30 Participants	658.33 Milligram per deciliter (mg/dL) n=31 Participants	643.0 Milligram per deciliter (mg/dL) n=91 Participants
Non-high-density lipoprotein cholesterol (non-HDL-C)	238.75 mg/dL n=30 Participants	190.0 mg/dL n=30 Participants	201.00 mg/dL n=31 Participants	205.00 mg/dL n=91 Participants
High-density lipoprotein cholesterol (HDL-C)	28.50 mg/dL n=30 Participants	28.00 mg/dL n=30 Participants	29.00 mg/dL n=31 Participants	28.0 mg/dL n=91 Participants
Very low-density lipoprotein cholesterol (VLDL-C)	108.50 mg/dL n=30 Participants	102.50 mg/dL n=30 Participants	117.00 mg/dL n=31 Participants	110.00 mg/dL n=91 Participants
Total Cholesterol (TC)	273.00 mg/dL n=30 Participants	219.00 mg/dL n=30 Participants	235.00 mg/dL n=31 Participants	237.00 mg/dL n=91 Participants
Low-density lipoprotein cholesterol (LDL-C)	97.00 mg/dL n=30 Participants	87.00 mg/dL n=30 Participants	76.00 mg/dL n=31 Participants	87.00 mg/dL n=91 Participants
High-density lipoprotein Triglyceride (HDL-TG)	34.5 mg/dL n=30 Participants	33.0 mg/dL n=30 Participants	36.0 mg/dL n=31 Participants	35.0 mg/dL n=91 Participants
Very low-density lipoprotein Triglyceride (VLDL-TG)	476.0 mg/dL n=30 Participants	462.0 mg/dL n=30 Participants	541.0 mg/dL n=31 Participants	506.0 mg/dL n=91 Participants
Low-density lipoprotein Triglyceride (LDL-TG)	59.0 mg/dL n=30 Participants	47.5 mg/dL n=30 Participants	54.0 mg/dL n=31 Participants	53.0 mg/dL n=91 Participants
Apolipoprotein B (ApoB)	113.5 mg/dL n=30 Participants	107.0 mg/dL n=30 Participants	110.0 mg/dL n=31 Participants	111.0 mg/dL n=91 Participants
Apolipoprotein A-I (ApoA-I)	130.0 mg/dL n=30 Participants	121.0 mg/dL n=30 Participants	133.0 mg/dL n=31 Participants	130.0 mg/dL n=91 Participants
Apolipoprotein A-II (ApoA-II)	35.0 mg/dL n=30 Participants	33.0 mg/dL n=30 Participants	34.0 mg/dL n=31 Participants	34.0 mg/dL n=91 Participants
Apolipoprotein C-II (ApoC-II)	10 mg/dL n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	10 mg/dL n=29 Participants • FAS Population. Here, number analyzed signifies participants with available data.	10 mg/dL n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	10 mg/dL n=89 Participants • FAS Population. Here, number analyzed signifies participants with available data.
Apolipoprotein C-III (ApoC-III)	25.5 mg/dL n=30 Participants	25.0 mg/dL n=30 Participants	27.0 mg/dL n=31 Participants	26.0 mg/dL n=91 Participants
Apolipoprotein B (ApoE)	8.1 mg/dL n=30 Participants	7.8 mg/dL n=30 Participants	9.1 mg/dL n=31 Participants	8.5 mg/dL n=91 Participants
High-sensitivity C-reactive protein (hsCRP)	3.65 mg/dL n=30 Participants	2.75 mg/dL n=30 Participants	2.50 mg/dL n=31 Participants	3.20 mg/dL n=91 Participants
Fibrinogen	418.5 mg/dL n=30 Participants	415.0 mg/dL n=30 Participants	375.0 mg/dL n=31 Participants	400.0 mg/dL n=91 Participants
Adiponectin	3.9 Microgram per milliliter (μg/mL) n=30 Participants	4.3 Microgram per milliliter (μg/mL) n=30 Participants	4.4 Microgram per milliliter (μg/mL) n=31 Participants	4.2 Microgram per milliliter (μg/mL) n=91 Participants
Serum amyloid A	5.9 Milligram per Liter (mg/L) n=30 Participants	4.8 Milligram per Liter (mg/L) n=30 Participants	5.0 Milligram per Liter (mg/L) n=31 Participants	5.3 Milligram per Liter (mg/L) n=91 Participants
Interleukin-6	2.6 Picogram per milliliter (pg/mL) n=29 Participants • FAS Population. Here, number analyzed signifies participants with available data.	2.1 Picogram per milliliter (pg/mL) n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	2.5 Picogram per milliliter (pg/mL) n=31 Participants • FAS Population. Here, number analyzed signifies participants with available data.	2.3 Picogram per milliliter (pg/mL) n=90 Participants • FAS Population. Here, number analyzed signifies participants with available data.
Angiopoietin 4	204.1 Nanogram per milliliter (ng/mL) n=30 Participants	171.8 Nanogram per milliliter (ng/mL) n=30 Participants	165.7 Nanogram per milliliter (ng/mL) n=31 Participants	176.6 Nanogram per milliliter (ng/mL) n=91 Participants
Lipoprotein size Very low density lipoprotein (VLDL)	64.90 Nanometer (nm) n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	62.25 Nanometer (nm) n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	68.80 Nanometer (nm) n=31 Participants • FAS Population. Here, number analyzed signifies participants with available data.	64.60 Nanometer (nm) n=91 Participants • FAS Population. Here, number analyzed signifies participants with available data.
Lipoprotein size low density lipoprotein (LDL)	19.60 Nanometer (nm) n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	19.60 Nanometer (nm) n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	19.60 Nanometer (nm) n=29 Participants • FAS Population. Here, number analyzed signifies participants with available data.	19.60 Nanometer (nm) n=89 Participants • FAS Population. Here, number analyzed signifies participants with available data.
Lipoprotein size High density lipoprotein (HDL)	8.700 Nanometer (nm) n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	8.500 Nanometer (nm) n=30 Participants • FAS Population. Here, number analyzed signifies participants with available data.	8.700 Nanometer (nm) n=31 Participants • FAS Population. Here, number analyzed signifies participants with available data.	8.700 Nanometer (nm) n=91 Participants • FAS Population. Here, number analyzed signifies participants with available data.
HDL Particle Number	30.450 Micro mole per Liter (umol/L) n=30 Participants	28.500 Micro mole per Liter (umol/L) n=30 Participants	30.800 Micro mole per Liter (umol/L) n=31 Participants	29.700 Micro mole per Liter (umol/L) n=91 Participants
Lipoprotein Particle Number VLDL and Chylomicron Particles	147.90 Nano mole per Liter (nmol/L) n=30 Participants	145.35 Nano mole per Liter (nmol/L) n=30 Participants	140.90 Nano mole per Liter (nmol/L) n=31 Participants	147.20 Nano mole per Liter (nmol/L) n=91 Participants
Lipoprotein Particle Number LDL Particles	1447.50 Nano mole per Liter (nmol/L) n=30 Participants	1228.50 Nano mole per Liter (nmol/L) n=30 Participants	1178.00 Nano mole per Liter (nmol/L) n=31 Participants	1259.00 Nano mole per Liter (nmol/L) n=91 Participants
Lipoprotein Particle Number Intermediate Density Lipoprotein (IDL) Particles	164.5 Nano mole per Liter (nmol/L) n=30 Participants	114.0 Nano mole per Liter (nmol/L) n=30 Participants	137.0 Nano mole per Liter (nmol/L) n=31 Participants	137.0 Nano mole per Liter (nmol/L) n=91 Participants

PRIMARY outcome

Timeframe: Baseline, EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG)	-47.32 Percent Change Interval -59.58 to -30.93	-32.95 Percent Change Interval -48.53 to -12.21	-27.30 Percent Change Interval -41.9 to 10.12

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10 and 12

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Fasting Serum TG Week 2	-27.46 Percent Change Interval -49.03 to -14.03	-27.10 Percent Change Interval -46.77 to 2.24	-27.07 Percent Change Interval -37.53 to 11.01
Percent Change From Baseline in Fasting Serum TG Week 6	-38.63 Percent Change Interval -50.24 to -18.99	-25.11 Percent Change Interval -46.46 to -5.47	-22.18 Percent Change Interval -41.48 to -5.17
Percent Change From Baseline in Fasting Serum TG Week 10	-49.90 Percent Change Interval -58.32 to -25.53	-32.83 Percent Change Interval -47.65 to -18.99	-18.75 Percent Change Interval -46.07 to 11.55
Percent Change From Baseline in Fasting Serum TG Week 12	-41.88 Percent Change Interval -57.53 to -25.04	-36.01 Percent Change Interval -48.92 to -10.1	-37.30 Percent Change Interval -48.35 to -5.46

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Fasting Serum TG EOS	-288.42 mg/dL Interval -411.83 to -156.33	-219.67 mg/dL Interval -340.83 to -71.17	-154.00 mg/dL Interval -380.33 to 49.83
Change From Baseline in Fasting Serum TG Week 2	-221.83 mg/dL Interval -359.0 to -83.67	-161.00 mg/dL Interval -306.67 to 11.67	-163.67 mg/dL Interval -302.67 to 58.0
Change From Baseline in Fasting Serum TG Week 6	-272.33 mg/dL Interval -355.33 to -162.67	-173.83 mg/dL Interval -301.33 to -27.67	-130.00 mg/dL Interval -263.67 to -33.0
Change From Baseline in Fasting Serum TG Week 10	-298.33 mg/dL Interval -456.33 to -141.0	-173.50 mg/dL Interval -390.67 to -105.67	-131.00 mg/dL Interval -312.67 to 91.0
Change From Baseline in Fasting Serum TG Week 12	-234.33 mg/dL Interval -482.33 to -165.0	-230.67 mg/dL Interval -308.33 to -59.67	-202.67 mg/dL Interval -407.67 to -32.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in TC Week 2	-12.67 Percent Change Interval -24.84 to 2.33	-4.48 Percent Change Interval -20.0 to 4.73	-2.67 Percent Change Interval -14.74 to 7.38
Percent Change From Baseline in TC Week 6	-17.00 Percent Change Interval -26.25 to 0.85	-8.68 Percent Change Interval -13.66 to 4.67	-6.12 Percent Change Interval -13.43 to 5.31
Percent Change From Baseline in TC Week 10	-17.23 Percent Change Interval -30.86 to -6.5	-8.44 Percent Change Interval -17.83 to 2.29	-2.42 Percent Change Interval -12.56 to 10.2
Percent Change From Baseline in TC Week 12	-10.25 Percent Change Interval -30.94 to -1.81	-8.62 Percent Change Interval -13.18 to 7.34	-6.93 Percent Change Interval -18.18 to 14.97
Percent Change From Baseline in TC EOS	-13.65 Percent Change Interval -31.91 to -5.13	-7.28 Percent Change Interval -19.92 to 6.49	-2.82 Percent Change Interval -16.46 to 10.8

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in TC Week 10	-41.25 mg/dL Interval -89.0 to -13.5	-16.00 mg/dL Interval -49.5 to 3.0	-2.50 mg/dL Interval -33.5 to 20.5
Change From Baseline in TC Week 12	-28.25 mg/dL Interval -79.0 to -3.5	-19.75 mg/dL Interval -53.5 to 14.0	-14.00 mg/dL Interval -42.5 to 29.5
Change From Baseline in TC EOS	-35.50 mg/dL Interval -90.5 to -13.5	-14.25 mg/dL Interval -51.5 to 8.5	-3.00 mg/dL Interval -36.5 to 25.0
Change From Baseline in TC Week 2	-25.75 mg/dL Interval -65.0 to 5.0	-10.25 mg/dL Interval -51.5 to 8.0	-5.50 mg/dL Interval -36.0 to 17.0
Change From Baseline in TC Week 6	-41.50 mg/dL Interval -76.5 to 2.0	-18.75 mg/dL Interval -32.5 to 7.0	-13.50 mg/dL Interval -31.5 to 6.5

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Non-HDL-C Week 2	-13.92 Percent Change Interval -29.92 to -0.78	-6.35 Percent Change Interval -21.52 to 3.23	-3.29 Percent Change Interval -15.62 to 8.9
Percent Change From Baseline in Non-HDL-C Week 6	-22.57 Percent Change Interval -32.16 to -0.77	-10.55 Percent Change Interval -14.29 to 2.84	-7.77 Percent Change Interval -16.28 to 4.23
Percent Change From Baseline in Non-HDL-C Week 10	-22.18 Percent Change Interval -35.66 to -7.92	-11.18 Percent Change Interval -22.19 to 2.23	-7.66 Percent Change Interval -17.18 to 13.36
Percent Change From Baseline in Non-HDL-C Week 12	-13.31 Percent Change Interval -36.34 to -3.37	-9.92 Percent Change Interval -19.31 to 11.35	-10.56 Percent Change Interval -22.62 to 19.21
Percent Change From Baseline in Non-HDL-C EOS	-15.64 Percent Change Interval -38.11 to -5.26	-12.01 Percent Change Interval -21.88 to 7.1	-3.98 Percent Change Interval -20.8 to 11.56

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Non-HDL-C Week 2	-30.75 mg/dL Interval -73.5 to -2.0	-12.25 mg/dL Interval -52.5 to 5.5	-6.50 mg/dL Interval -36.0 to 15.0
Change From Baseline in Non-HDL-C Week 6	-43.50 mg/dL Interval -81.5 to -2.5	-19.75 mg/dL Interval -34.5 to 5.0	-16.50 mg/dL Interval -38.5 to 6.0
Change From Baseline in Non-HDL-C Week 10	-45.00 mg/dL Interval -93.0 to -15.5	-23.00 mg/dL Interval -52.0 to 4.0	-7.50 mg/dL Interval -39.5 to 22.0
Change From Baseline in Non-HDL-C Week 12	-29.00 mg/dL Interval -90.0 to -9.0	-22.25 mg/dL Interval -54.5 to 15.0	-16.00 mg/dL Interval -51.0 to 31.0
Change From Baseline in Non-HDL-C EOS	-36.50 mg/dL Interval -93.0 to -14.5	-21.25 mg/dL Interval -50.0 to 11.5	-7.00 mg/dL Interval -42.5 to 21.5

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in VLDL-C Week 6	-36.41 Percent Change Interval -50.0 to -18.75	-43.31 Percent Change Interval -50.51 to -4.55	-33.50 Percent Change Interval -53.68 to -2.57
Percent Change From Baseline in VLDL-C Week 2	-46.19 Percent Change Interval -57.52 to -21.18	-46.27 Percent Change Interval -63.78 to -5.41	-29.59 Percent Change Interval -48.36 to 18.87
Percent Change From Baseline in VLDL-C Week 10	-32.71 Percent Change Interval -60.0 to -14.41	-16.67 Percent Change Interval -52.9 to 11.01	-7.85 Percent Change Interval -41.03 to 28.93
Percent Change From Baseline in VLDL-C Week 12	-31.34 Percent Change Interval -51.74 to -6.92	-19.14 Percent Change Interval -39.8 to 15.38	-31.69 Percent Change Interval -44.21 to 20.57
Percent Change From Baseline in VLDL-C EOS	-31.95 Percent Change Interval -50.0 to -12.5	-15.95 Percent Change Interval -50.51 to 15.38	-17.57 Percent Change Interval -39.89 to 27.71

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in VLDL-C Week 6	-37.50 mg/dL Interval -57.0 to -12.0	-50.00 mg/dL Interval -70.0 to -3.0	-31.50 mg/dL Interval -67.5 to -1.5
Change From Baseline in VLDL-C Week 10	-25.50 mg/dL Interval -73.0 to -17.0	-15.00 mg/dL Interval -68.0 to 12.0	-7.00 mg/dL Interval -48.0 to 20.0
Change From Baseline in VLDL-C Week 2	-47.00 mg/dL Interval -74.0 to -18.5	-60 mg/dL Interval -84.0 to -4.0	-29.00 mg/dL Interval -59.0 to 10.0
Change From Baseline in VLDL-C Week 12	-26.00 mg/dL Interval -68.0 to -10.0	-19.00 mg/dL Interval -73.0 to 12.0	-24.00 mg/dL Interval -62.0 to 21.0
Change From Baseline in VLDL-C EOS	-32.50 mg/dL Interval -56.0 to -10.5	-13.00 mg/dL Interval -71.5 to 12.0	-19.50 mg/dL Interval -63.0 to 23.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in HDL-C Week 6	5.33 Percent Change Interval -6.67 to 17.65	7.42 Percent Change Interval -7.14 to 13.33	0.00 Percent Change Interval -3.7 to 21.21
Percent Change From Baseline in HDL-C Week 10	5.87 Percent Change Interval -4.35 to 29.41	7.14 Percent Change Interval -4.0 to 18.75	10.34 Percent Change Interval 0.0 to 22.22
Percent Change From Baseline in HDL-C EOS	9.30 Percent Change Interval -7.5 to 23.53	7.04 Percent Change Interval -7.69 to 17.86	8.70 Percent Change Interval -3.85 to 21.74
Percent Change From Baseline in HDL-C Week 2	5.96 Percent Change Interval -3.03 to 28.57	3.85 Percent Change Interval -7.14 to 14.29	4.35 Percent Change Interval -7.69 to 15.38
Percent Change From Baseline in HDL-C Week 12	14.72 Percent Change Interval -9.52 to 23.81	7.29 Percent Change Interval -3.7 to 20.0	7.69 Percent Change Interval -4.35 to 25.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in HDL-C Week 6	1.50 mg/dL Interval -2.0 to 5.0	2.00 mg/dL Interval -2.0 to 4.0	0.00 mg/dL Interval -1.0 to 6.0
Change From Baseline in HDL-C Week 10	2.00 mg/dL Interval -1.0 to 7.0	2.00 mg/dL Interval -1.0 to 4.0	3.00 mg/dL Interval 0.0 to 5.0
Change From Baseline in HDL-C Week 12	4.00 mg/dL Interval -3.0 to 8.0	2.00 mg/dL Interval -1.0 to 5.0	2.00 mg/dL Interval -1.0 to 8.0
Change From Baseline in HDL-C EOS	3.00 mg/dL Interval -2.0 to 6.0	2.00 mg/dL Interval -2.0 to 4.0	2.00 mg/dL Interval -1.0 to 5.0
Change From Baseline in HDL-C Week 2	2.00 mg/dL Interval -1.0 to 7.0	1.00 mg/dL Interval -2.0 to 4.0	1 mg/dL Interval -3.0 to 4.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable at each specified time point only.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Apolipoprotein B Week 10	-10.5 Percent Change Interval -28.1 to 4.3	-2.7 Percent Change Interval -9.2 to 5.6	0.0 Percent Change Interval -5.1 to 8.9
Percent Change From Baseline in Apolipoprotein B Week 12	-4.7 Percent Change Interval -26.1 to 6.6	0.5 Percent Change Interval -8.6 to 16.2	4.8 Percent Change Interval -6.4 to 13.0
Percent Change From Baseline in Apolipoprotein B EOS	-5.9 Percent Change Interval -25.7 to 4.9	-1.9 Percent Change Interval -8.7 to 11.4	2.8 Percent Change Interval -5.0 to 7.6

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Population: 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.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Apolipoprotein B Week 10	-10.0 mg/dL Interval -37.0 to 4.0	-4.0 mg/dL Interval -13.0 to 6.0	0.0 mg/dL Interval -5.0 to 9.0
Change From Baseline in Apolipoprotein B Week 12	-7.0 mg/dL Interval -30.0 to 8.0	0.5 mg/dL Interval -13.0 to 12.0	5.5 mg/dL Interval -6.0 to 16.0
Change From Baseline in Apolipoprotein B EOS	-8.5 mg/dL Interval -34.5 to 5.5	-1.8 mg/dL Interval -13.0 to 9.5	2.8 mg/dL Interval -5.5 to 9.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Apolipoprotein A-I Week 10	-3.3 Percent Change Interval -9.7 to 6.3	5.1 Percent Change Interval -5.6 to 12.2	2.7 Percent Change Interval -3.4 to 6.5
Percent Change From Baseline in Apolipoprotein A-I Week 12	5.9 Percent Change Interval -4.9 to 12.1	4.0 Percent Change Interval -2.7 to 13.2	2.1 Percent Change Interval -3.6 to 10.8
Percent Change From Baseline in Apolipoprotein A-I EOS	1.2 Percent Change Interval -4.5 to 8.1	4.6 Percent Change Interval -1.4 to 12.4	2.0 Percent Change Interval -5.4 to 9.9

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Apolipoprotein A-I Week 10	5.0 mg/dL Interval -13.0 to 7.0	6.0 mg/dL Interval -7.0 to 13.0	4.0 mg/dL Interval -5.0 to 9.0
Change From Baseline in Apolipoprotein A-I Week 12	8.0 mg/dL Interval -6.0 to 16.0	4.5 mg/dL Interval -3.0 to 15.0	2.5 mg/dL Interval -4.0 to 15.0
Change From Baseline in Apolipoprotein A-I EOS	1.5 mg/dL Interval -7.0 to 10.0	5.5 mg/dL Interval -2.0 to 13.0	2.5 mg/dL Interval -7.0 to 14.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Apolipoprotein A-II Week 10	-3.2 Percent Change Interval -8.1 to 5.9	6.9 Percent Change Interval -3.3 to 12.5	0.0 Percent Change Interval -7.1 to 7.3
Percent Change From Baseline in Apolipoprotein A-II Week 12	0.0 Percent Change Interval -2.9 to 10.0	4.5 Percent Change Interval 0.0 to 15.2	0.0 Percent Change Interval -6.9 to 7.5
Percent Change From Baseline in Apolipoprotein A-II EOS	0.0 Percent Change Interval -5.4 to 5.6	5.3 Percent Change Interval -3.1 to 12.1	0.0 Percent Change Interval -5.6 to 8.1

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Apolipoprotein A-II Week 10	-1.0 mg/dL Interval -3.0 to 2.0	2.0 mg/dL Interval -1.0 to 4.0	0.0 mg/dL Interval -2.0 to 3.0
Change From Baseline in Apolipoprotein A-II Week 12	0.0 mg/dL Interval -1.0 to 4.0	1.5 mg/dL Interval 0.0 to 5.0	0.0 mg/dL Interval -2.0 to 3.0
Change From Baseline in Apolipoprotein A-II EOS	0.0 mg/dL Interval -1.5 to 2.0	1.8 mg/dL Interval -1.0 to 4.0	0.0 mg/dL Interval -2.0 to 2.5

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Apolipoprotein C-II EOS	0.0 Percent Change Interval -5.0 to 0.0	0.0 Percent Change Interval 0.0 to 0.0	0.0 Percent Change Interval -5.6 to 0.0
Percent Change From Baseline in Apolipoprotein C-II Week 10	0.0 Percent Change Interval 0.0 to 0.0	0.0 Percent Change Interval 0.0 to 0.0	0.0 Percent Change Interval 0.0 to 0.0
Percent Change From Baseline in Apolipoprotein C-II Week 12	0.0 Percent Change Interval 0.0 to 0.0	0.0 Percent Change Interval 0.0 to 0.0	0.0 Percent Change Interval -10.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Apolipoprotein C-II Week 12	0.0 mg/dL Interval 0.0 to 0.0	0.0 mg/dL Interval 0.0 to 0.0	0.0 mg/dL Interval -1.0 to 0.0
Change From Baseline in Apolipoprotein C-II Week 10	0.0 mg/dL Interval 0.0 to 0.0	0.0 mg/dL Interval 0.0 to 0.0	0.0 mg/dL Interval 0.0 to 0.0
Change From Baseline in Apolipoprotein C-II EOS	0.0 mg/dL Interval -0.5 to 0.0	0.0 mg/dL Interval 0.0 to 0.0	0.0 mg/dL Interval -0.5 to 0.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Apolipoprotein C-III EOS	-17.6 Percent Change Interval -39.6 to -7.1	-11.3 Percent Change Interval -31.5 to 8.3	-8.1 Percent Change Interval -29.3 to 9.1
Percent Change From Baseline in Apolipoprotein C-III Week 10	-21.1 Percent Change Interval -40.0 to -4.7	-14.3 Percent Change Interval -35.6 to 11.1	-3.6 Percent Change Interval -33.2 to 16.5
Percent Change From Baseline in Apolipoprotein C-III Week 12	-17.6 Percent Change Interval -35.5 to -5.6	-6.4 Percent Change Interval -27.7 to 14.3	-10.7 Percent Change Interval -37.5 to 0.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Apolipoprotein C-III Week 10	-6.0 mg/dL Interval -12.0 to -2.0	-4.0 mg/dL Interval -9.0 to 1.0	-1.0 mg/dL Interval -10.5 to 3.0
Change From Baseline in Apolipoprotein C-III Week 12	-4.0 mg/dL Interval -9.0 to -1.0	-2.0 mg/dL Interval -6.0 to 2.0	-3.0 mg/dL Interval -13.0 to 0.0
Change From Baseline in Apolipoprotein C-III EOS	-5.5 mg/dL Interval -12.0 to -2.0	-3.3 mg/dL Interval -8.0 to 2.0	-2.0 mg/dL Interval -9.5 to 2.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Apolipoprotein E Week 10	-36.3 Percent Change Interval -46.4 to -26.4	-22.6 Percent Change Interval -42.4 to 8.2	-9.2 Percent Change Interval -39.0 to 14.3
Percent Change From Baseline in Apolipoprotein E Week 12	-27.5 Percent Change Interval -43.5 to -1.6	-14.6 Percent Change Interval -41.7 to 10.0	-25.7 Percent Change Interval -43.4 to 14.7
Percent Change From Baseline in Apolipoprotein E EOS	-33.2 Percent Change Interval -45.3 to -13.5	-16.7 Percent Change Interval -43.1 to 10.6	-10.4 Percent Change Interval -40.2 to 20.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Apolipoprotein E Week 10	-3.0 mg/dL Interval -5.4 to -1.9	-1.8 mg/dL Interval -4.2 to 0.5	-0.9 mg/dL Interval -4.4 to 1.0
Change From Baseline in Apolipoprotein E Week 12	-2.2 mg/dL Interval -4.0 to -0.1	-1.4 mg/dL Interval -4.1 to 0.7	-1.8 mg/dL Interval -5.5 to 1.6
Change From Baseline in Apolipoprotein E EOS	-2.9 mg/dL Interval -4.9 to -1.0	-1.3 mg/dL Interval -4.2 to 0.5	-0.9 mg/dL Interval -4.9 to 1.5

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in LDL-C Week 12	-7.94 Percent Change Interval -26.39 to 22.97	5.20 Percent Change Interval -13.04 to 26.67	25.43 Percent Change Interval 2.99 to 42.86
Percent Change From Baseline in LDL-C Week 10	-13.64 Percent Change Interval -27.03 to 26.32	4.39 Percent Change Interval -14.0 to 29.03	0.00 Percent Change Interval -7.92 to 32.14
Percent Change From Baseline in LDL-C EOS	-13.36 Percent Change Interval -25.79 to 19.66	5.26 Percent Change Interval -12.68 to 27.94	14.73 Percent Change Interval 0.0 to 37.5

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in LDL-C Week 10	-12.00 mg/dL Interval -42.0 to 15.0	3.00 mg/dL Interval -14.0 to 23.0	0.00 mg/dL Interval -6.0 to 18.0
Change From Baseline in LDL-C Week 12	-10.00 mg/dL Interval -23.0 to 17.0	4.50 mg/dL Interval -16.0 to 25.0	17.50 mg/dL Interval 2.0 to 29.0
Change From Baseline in LDL-C EOS	-11.50 mg/dL Interval -31.0 to 19.0	5.75 mg/dL Interval -11.5 to 21.0	8.75 mg/dL Interval 0.0 to 20.5

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in LDL-TG Week 10	-17.1 Percent Change Interval -35.6 to -4.2	-12.2 Percent Change Interval -33.3 to 7.1	0.8 Percent Change Interval -19.8 to 13.9
Percent Change From Baseline in LDL-TG Week 12	-17.5 Percent Change Interval -45.8 to 9.1	-7.2 Percent Change Interval -28.6 to 31.0	-6.0 Percent Change Interval -18.6 to 12.7
Percent Change From Baseline in LDL-TG EOS	-20.0 Percent Change Interval -37.5 to 4.4	-9.3 Percent Change Interval -17.8 to 16.1	-6.8 Percent Change Interval -16.7 to 13.6

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in LDL-TG Week 10	-11.0 mg/dL Interval -21.0 to -1.0	-6.5 mg/dL Interval -19.0 to 2.0	0.5 mg/dL Interval -10.0 to 7.5
Change From Baseline in LDL-TG Week 12	-10.0 mg/dL Interval -29.0 to 4.0	-4.0 mg/dL Interval -11.0 to 10.0	-3.0 mg/dL Interval -11.0 to 7.0
Change From Baseline in LDL-TG EOS	-12.5 mg/dL Interval -25.0 to 2.0	-4.0 mg/dL Interval -12.0 to 5.0	-3.3 mg/dL Interval -8.5 to 8.5

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in VLDL-TG Week 10	-39.7 Percent Change Interval -60.6 to -21.2	-32.8 Percent Change Interval -58.6 to 28.7	-11.0 Percent Change Interval -53.9 to 19.5
Percent Change From Baseline in VLDL-TG Week 12	-34.8 Percent Change Interval -59.0 to -15.3	-27.0 Percent Change Interval -47.5 to 8.8	-37.3 Percent Change Interval -56.4 to -6.9
Percent Change From Baseline in VLDL-TG EOS	-35.2 Percent Change Interval -57.7 to -23.3	-30.8 Percent Change Interval -52.8 to 38.4	-23.9 Percent Change Interval -51.3 to 10.6

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in VLDL-TG Week 10	-170.0 mg/dL Interval -493.0 to -86.0	-129.5 mg/dL Interval -241.0 to 84.0	-77.0 mg/dL Interval -274.0 to 67.0
Change From Baseline in VLDL-TG Week 12	-139.0 mg/dL Interval -351.0 to -83.0	-103.5 mg/dL Interval -320.0 to 52.0	-193.5 mg/dL Interval -524.0 to -28.0
Change From Baseline in VLDL-TG EOS	-164.0 mg/dL Interval -468.0 to -76.5	-116.5 mg/dL Interval -373.0 to 71.5	-126.8 mg/dL Interval -384.0 to 92.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in HDL-TG Week 10	-27.5 Percent Change Interval -51.6 to -11.8	-6.5 Percent Change Interval -35.8 to 11.5	-6.1 Percent Change Interval -26.7 to 19.2
Percent Change From Baseline in HDL-TG Week 12	-23.9 Percent Change Interval -54.1 to 3.0	-17.3 Percent Change Interval -37.8 to -2.9	-11.1 Percent Change Interval -31.3 to 21.7
Percent Change From Baseline in HDL-TG EOS	-20.6 Percent Change Interval -52.7 to 3.4	-11.2 Percent Change Interval -39.0 to 3.8	-1.4 Percent Change Interval -29.3 to 26.7

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in HDL-TG Week 10	-8.0 mg/dL Interval -25.0 to -3.0	-2.0 mg/dL Interval -15.0 to 3.0	-2.0 mg/dL Interval -11.0 to 6.0
Change From Baseline in HDL-TG Week 12	-8.0 mg/dL Interval -25.0 to 1.0	-5.5 mg/dL Interval -17.0 to -1.0	-4.0 mg/dL Interval -12.0 to 5.0
Change From Baseline in HDL-TG EOS	-7.0 mg/dL Interval -25.0 to 1.0	-3.5 mg/dL Interval -16.0 to 1.0	-0.5 mg/dL Interval -10.0 to 6.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: 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.

Percent change from baseline in Particle size for VLDL, HDL and LDL were reported.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Lipoprotein Size VLDL	-7.83 Percent Change Interval -16.46 to -0.31	-6.36 Percent Change Interval -14.9 to 9.72	-5.17 Percent Change Interval -16.55 to 3.34
Percent Change From Baseline in Lipoprotein Size LDL	0.00 Percent Change Interval 0.0 to 1.52	0.00 Percent Change Interval 0.0 to 0.95	0.51 Percent Change Interval -0.51 to 1.03
Percent Change From Baseline in Lipoprotein Size HDL	0.000 Percent Change Interval -2.299 to 2.273	0.000 Percent Change Interval -2.353 to 2.353	0.000 Percent Change Interval -2.151 to 1.205

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: 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.

Change from baseline in Particle size for VLDL, HDL and LDL were reported.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Lipoprotein Size VLDL	-5.10 nm Interval -10.6 to -0.2	-3.90 nm Interval -10.8 to 5.9	-3.10 nm Interval -12.2 to 2.3
Change From Baseline in Lipoprotein Size LDL	0.00 nm Interval 0.0 to 0.3	0.00 nm Interval 0.0 to 0.2	0.10 nm Interval -0.1 to 0.2
Change From Baseline in Lipoprotein Size HDL	0.000 nm Interval -0.2 to 0.2	0.000 nm Interval -0.2 to 0.2	0.000 nm Interval -0.2 to 0.1

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: 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.

Percent change from baseline in particle number for VLDL \& chylomicron, LDL and IDL were reported.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Lipoprotein Particle Number LDL Particles	-9.83 Percent Change Interval -32.15 to 7.53	-10.20 Percent Change Interval -25.14 to 15.54	13.96 Percent Change Interval -13.73 to 36.46
Percent Change From Baseline in Lipoprotein Particle Number IDL Particles	-73.1 Percent Change Interval -90.1 to 17.9	-2.2 Percent Change Interval -83.2 to 36.3	16.7 Percent Change Interval -67.5 to 217.6
Percent Change From Baseline in Lipoprotein Particle Number VLDL and Chylomicron Particles	-15.82 Percent Change Interval -22.82 to 7.6	-3.88 Percent Change Interval -19.1 to 23.25	-4.03 Percent Change Interval -14.33 to 26.67

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: 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.

Change from baseline in particle number for VLDL \& chylomicron, LDL and IDL were reported.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Lipoprotein Particle Number VLDL and Chylomicron Particles	-10.90 nmol/L Interval -49.1 to 10.5	-6.40 nmol/L Interval -32.3 to 24.5	-4.30 nmol/L Interval -27.3 to 32.3
Change From Baseline in Lipoprotein Particle Number IDL Particles	-67.0 nmol/L Interval -191.0 to 24.0	-14.0 nmol/L Interval -72.0 to 31.0	1.0 nmol/L Interval -96.0 to 86.0
Change From Baseline in Lipoprotein Particle Number LDL Particles	-103.00 nmol/L Interval -525.0 to 88.0	-82.00 nmol/L Interval -341.0 to 160.0	160.0 nmol/L Interval -134.0 to 425.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in HDL Particle Number	-0.578 Percent Change Interval -11.111 to 13.889	0.304 Percent Change Interval -5.079 to 12.253	0.000 Percent Change Interval -5.296 to 8.696

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in HDL Particle Number	-0.200 umol/L Interval -4.1 to 3.4	0.100 umol/L Interval -1.6 to 3.8	0.000 umol/L Interval -1.6 to 2.3

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in High-sensitivity C-reactive Protein Week 10	-33.33 Percent Change Interval -54.29 to 0.0	-26.67 Percent Change Interval -44.9 to 15.56	-10.00 Percent Change Interval -30.0 to 14.29
Percent Change From Baseline in High-sensitivity C-reactive Protein Week 12	-16.67 Percent Change Interval -60.61 to 0.0	-25.48 Percent Change Interval -57.89 to 5.56	10.99 Percent Change Interval -28.57 to 42.86
Percent Change From Baseline in High-sensitivity C-reactive Protein EOS	-23.68 Percent Change Interval -53.57 to 3.45	-16.94 Percent Change Interval -55.26 to 17.11	-0.71 Percent Change Interval -25.0 to 50.0

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in High-sensitivity C-reactive Protein Week 10	-0.90 mg/dL Interval -1.9 to 0.0	-0.40 mg/dL Interval -1.5 to 0.2	-0.10 mg/dL Interval -1.2 to 0.2
Change From Baseline in High-sensitivity C-reactive Protein Week 12	-0.60 mg/dL Interval -2.0 to 0.0	-0.50 mg/dL Interval -1.5 to 0.1	0.10 mg/dL Interval -0.4 to 1.2
Change From Baseline in High-sensitivity C-reactive Protein EOS	-0.75 mg/dL Interval -1.95 to 0.1	-0.28 mg/dL Interval -1.5 to 0.4	-0.02 mg/dL Interval -0.6 to 0.65

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Fibrinogen Week 10	1.2 Percent Change Interval -11.0 to 13.5	-6.7 Percent Change Interval -14.2 to 7.4	-3.5 Percent Change Interval -10.2 to 8.8
Percent Change From Baseline in Fibrinogen Week 12	-1.8 Percent Change Interval -15.0 to 5.4	-11.4 Percent Change Interval -19.3 to 0.8	-3.4 Percent Change Interval -11.6 to 4.6
Percent Change From Baseline in Fibrinogen EOS	-0.2 Percent Change Interval -13.5 to 8.9	-8.4 Percent Change Interval -15.1 to 0.8	-3.1 Percent Change Interval -9.6 to 6.8

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Fibrinogen Week 10	5.0 mg/dL Interval -50.0 to 54.0	-22.0 mg/dL Interval -53.0 to 26.0	-15.0 mg/dL Interval -38.0 to 37.0
Change From Baseline in Fibrinogen Week 12	-7.0 mg/dL Interval -63.0 to 23.0	-50.0 mg/dL Interval -80.0 to 3.0	-12.0 mg/dL Interval -46.0 to 17.0
Change From Baseline in Fibrinogen EOS	-1.0 mg/dL Interval -56.5 to 40.5	-35.0 mg/dL Interval -71.0 to 3.0	-14.3 mg/dL Interval -36.5 to 22.5

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Serum Amyloid A Week 10	-33.3 Percent Change Interval -45.8 to -16.2	-19.2 Percent Change Interval -38.2 to -3.0	-12.5 Percent Change Interval -31.5 to 0.0
Percent Change From Baseline in Serum Amyloid A Week 12	-36.7 Percent Change Interval -58.7 to -15.4	-29.2 Percent Change Interval -58.6 to 0.0	-7.2 Percent Change Interval -20.6 to 17.3
Percent Change From Baseline in Serum Amyloid A EOS	-31.8 Percent Change Interval -51.1 to -1.7	-19.6 Percent Change Interval -52.9 to 8.9	-7.2 Percent Change Interval -21.7 to 11.3

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Serum Amyloid A EOS	-1.5 mg/L Interval -2.7 to -0.1	-0.8 mg/L Interval -2.7 to 0.5	-0.2 mg/L Interval -1.1 to 0.6
Change From Baseline in Serum Amyloid A Week 10	-1.5 mg/L Interval -2.5 to -0.7	-0.6 mg/L Interval -2.1 to -0.1	-0.4 mg/L Interval -1.6 to 0.0
Change From Baseline in Serum Amyloid A Week 12	-2.1 mg/L Interval -3.3 to -0.6	-0.9 mg/L Interval -2.7 to 0.0	-0.3 mg/L Interval -1.3 to 0.9

SECONDARY outcome

Timeframe: Baseline, Week 12 and EOS (average of week 10 and 12)

Population: 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.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Adiponectin Week 12	12.9 Percent Change Interval 0.9 to 36.5	12.4 Percent Change Interval -6.5 to 31.6	1.2 Percent Change Interval -12.7 to 15.1
Percent Change From Baseline in Adiponectin EOS	12.9 Percent Change Interval 0.9 to 36.5	12.4 Percent Change Interval -6.5 to 31.6	1.2 Percent Change Interval -12.7 to 15.1

SECONDARY outcome

Timeframe: Baseline, Week 12 and EOS (average of week 10 and 12)

Population: 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.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Adiponectin EOS	0.3 μg/mL Interval 0.0 to 0.9	0.3 μg/mL Interval -0.2 to 0.8	0.0 μg/mL Interval -0.7 to 0.6
Change From Baseline in Adiponectin Week 12	0.3 μg/mL Interval 0.0 to 0.9	0.3 μg/mL Interval -0.2 to 0.8	0.0 μg/mL Interval -0.7 to 0.6

SECONDARY outcome

Timeframe: Baseline, Week 12 and EOS (average of week 10 and 12)

Population: 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.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Angiopoietin 4 Week 12	8.5 Percent Change Interval -5.1 to 21.7	-1.6 Percent Change Interval -18.6 to 20.8	1.1 Percent Change Interval -6.9 to 15.2
Percent Change From Baseline in Angiopoietin 4 EOS	8.5 Percent Change Interval -15.1 to 21.7	-1.6 Percent Change Interval -18.6 to 20.8	1.1 Percent Change Interval -6.9 to 15.2

SECONDARY outcome

Timeframe: Baseline, Week 12 and EOS (average of week 10 and 12)

Population: 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.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=29 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=30 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Angiopoietin 4 Week 12	15.7 ng/mL Interval -14.1 to 56.7	-2.0 ng/mL Interval -36.8 to 48.5	2.8 ng/mL Interval -9.1 to 22.5
Change From Baseline in Angiopoietin 4 EOS	15.7 ng/mL Interval -14.1 to 56.7	-2.0 ng/mL Interval -36.8 to 48.5	2.8 ng/mL Interval -9.1 to 22.5

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percent Change From Baseline in Interleukin-6 Week 10	-7.7 Percent Change Interval -22.7 to 34.0	-10.2 Percent Change Interval -37.3 to 14.7	-1.1 Percent Change Interval -31.6 to 49.1
Percent Change From Baseline in Interleukin-6 Week 12	-6.2 Percent Change Interval -21.7 to 41.6	-7.5 Percent Change Interval -34.4 to 21.3	-10.6 Percent Change Interval -27.2 to 1.2
Percent Change From Baseline in Interleukin-6 EOS	-5.3 Percent Change Interval -17.7 to 30.7	-4.8 Percent Change Interval -28.3 to 37.4	-4.2 Percent Change Interval -27.2 to 35.5

SECONDARY outcome

Timeframe: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=29 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=29 Participants Participants received matching placebo orally, once daily for 12 weeks.
Change From Baseline in Interleukin-6 Week 10	-0.1 pg/mL Interval -0.7 to 0.4	-0.1 pg/mL Interval -0.8 to 0.3	-0.0 pg/mL Interval -0.9 to 1.0
Change From Baseline in Interleukin-6 Week 12	-0.1 pg/mL Interval -0.6 to 0.7	-0.2 pg/mL Interval -0.7 to 0.3	-0.2 pg/mL Interval -0.5 to 0.0
Change From Baseline in Interleukin-6 EOS	-0.1 pg/mL Interval -0.6 to 0.6	-0.2 pg/mL Interval -0.7 to 0.4	-0.1 pg/mL Interval -0.6 to 0.4

SECONDARY outcome

Timeframe: Weeks 10, 12 and EOS (average of week 10 and 12)

Population: FAS Population. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Gemcabene 600 mg n=30 Participants Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 Participants Participants received 300 mg of Gemcabene orally, once daily for 12 weeks.	Placebo n=31 Participants Participants received matching placebo orally, once daily for 12 weeks.
Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) Week 10	73.3 Percentage of participants	63.3 Percentage of participants	41.9 Percentage of participants
Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) Week 12	63.3 Percentage of participants	53.3 Percentage of participants	41.9 Percentage of participants
Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L) EOS	66.7 Percentage of participants	56.7 Percentage of participants	45.2 Percentage of participants

Adverse Events

Gemcabene 600 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Gemcabene 300 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcabene 600 mg n=30 participants at risk Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 participants at risk Participants received 300 mg Gemcabene orally, once daily for 12 weeks.	Placebo n=31 participants at risk Participants received matching placebo orally, once daily for 12 weeks.
Infections and infestations Cystitis	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)

Other adverse events

Additional Information

Vice President Clinical Operations

NeuroBo Pharmaceuticals

Phone: +1 (857) 702-9600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Gemcabene 600 mg n=30 participants at risk Participants received 600 mg Gemcabene orally, once daily for 12 weeks.	Gemcabene 300 mg n=30 participants at risk Participants received 300 mg Gemcabene orally, once daily for 12 weeks.	Placebo n=31 participants at risk Participants received matching placebo orally, once daily for 12 weeks.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Investigations Blood creatine phosphokinase increased	6.7% 2/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Haemoglobin decreased	6.7% 2/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Investigations Alanine aminotransferase increased	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Investigations Blood creatinine increased	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Glomerular filtration rate decreased	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Haematocrit decreased	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Transaminases increased	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Urine analysis abnormal	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Weight increased	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Activated partial thromboplastin time prolonged	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Gamma-glutamyltransferase increased	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Investigations Immunology test abnormal	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Metabolism and nutrition disorders Hyperinsulinaemia	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Renal and urinary disorders Nephropathy toxic	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Renal and urinary disorders Pollakiuria	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Renal and urinary disorders Dysuria	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Reproductive system and breast disorders Vulvovaginal burning sensation	20.0% 1/5 • Baseline to End of study (up to Day 113)	0.00% 0/1 • Baseline to End of study (up to Day 113)	0.00% 0/12 • Baseline to End of study (up to Day 113)
Reproductive system and breast disorders Vulvovaginal pruritus	20.0% 1/5 • Baseline to End of study (up to Day 113)	0.00% 0/1 • Baseline to End of study (up to Day 113)	0.00% 0/12 • Baseline to End of study (up to Day 113)
Reproductive system and breast disorders Breast mass	0.00% 0/5 • Baseline to End of study (up to Day 113)	0.00% 0/1 • Baseline to End of study (up to Day 113)	8.3% 1/12 • Baseline to End of study (up to Day 113)
Respiratory, thoracic and mediastinal disorders Asthma	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Metabolism and nutrition disorders Type 2 diabetes mellitus	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Back pain	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Muscle spasms	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Osteoarthritis	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Myalgia	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cyst	0.00% 0/5 • Baseline to End of study (up to Day 113)	0.00% 0/1 • Baseline to End of study (up to Day 113)	8.3% 1/12 • Baseline to End of study (up to Day 113)
Nervous system disorders Headache	3.3% 1/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	6.5% 2/31 • Baseline to End of study (up to Day 113)
Nervous system disorders Cervical radiculopathy	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Nervous system disorders Paraesthesia	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Nervous system disorders Dizziness	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Psychiatric disorders Insomnia	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Psychiatric disorders Anxiety	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Ear and labyrinth disorders Ear pain	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Eye disorders Cataract	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Eye disorders Dry eye	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Eye disorders Visual acuity reduced	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Nausea	6.7% 2/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Diarrhoea	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	12.9% 4/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Abdominal discomfort	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Dry mouth	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Bowel movement irregularity	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Vomiting	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	6.5% 2/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Abdominal distension	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Abdominal pain	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Constipation	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Dyspepsia	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Gastrointestinal disorders Flatulence	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
General disorders Fatigue	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
General disorders Oedema peripheral	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
General disorders Pain	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Immune system disorders Allergy to arthropod bite	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Infections and infestations Urinary tract infection	3.3% 1/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	9.7% 3/31 • Baseline to End of study (up to Day 113)
Infections and infestations Nasopharyngitis	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	6.5% 2/31 • Baseline to End of study (up to Day 113)
Infections and infestations Sinusitis	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Infections and infestations Upper respiratory tract Infection	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	6.5% 2/31 • Baseline to End of study (up to Day 113)
Infections and infestations Influenza	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Infections and infestations Tooth abscess	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Infections and infestations Conjunctivitis	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Infections and infestations Cystitis	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Infections and infestations Tooth infection	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Infections and infestations Vaginal infection	0.00% 0/5 • Baseline to End of study (up to Day 113)	0.00% 0/1 • Baseline to End of study (up to Day 113)	8.3% 1/12 • Baseline to End of study (up to Day 113)
Injury, poisoning and procedural complications Contusion	6.7% 2/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Injury, poisoning and procedural complications Overdose	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Injury, poisoning and procedural complications Foot fracture	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Injury, poisoning and procedural complications Wound	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Injury, poisoning and procedural complications Joint injury	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Skin and subcutaneous tissue disorders Pruritus	3.3% 1/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Skin and subcutaneous tissue disorders Ecchymosis	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Skin and subcutaneous tissue disorders Night sweats	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Skin and subcutaneous tissue disorders Rash	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Skin and subcutaneous tissue disorders Skin tightness	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)
Vascular disorders Haematoma	3.3% 1/30 • Baseline to End of study (up to Day 113)	0.00% 0/30 • Baseline to End of study (up to Day 113)	0.00% 0/31 • Baseline to End of study (up to Day 113)
Vascular disorders Hypertension	0.00% 0/30 • Baseline to End of study (up to Day 113)	3.3% 1/30 • Baseline to End of study (up to Day 113)	3.2% 1/31 • Baseline to End of study (up to Day 113)