Trial Outcomes & Findings for A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins (NCT NCT02634151)
NCT ID: NCT02634151
Last Updated: 2020-06-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2020-06-25
Participant Flow
Participants who had heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) and were on a statin therapy were enrolled in this study.
Participant milestones
| Measure |
Gemcabene 600 mg
Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.
|
Placebo
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
Full Analysis Set
|
53
|
52
|
|
Overall Study
Safety Set
|
54
|
51
|
|
Overall Study
COMPLETED
|
52
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Gemcabene 600 mg
Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.
|
Placebo
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Non-Compliance
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
FAS Population.Here, number analyzed signifies those participants who were evaluable in each category.
Baseline characteristics by cohort
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 9.30 • n=53 Participants
|
59.0 years
STANDARD_DEVIATION 9.67 • n=52 Participants
|
60.8 years
STANDARD_DEVIATION 9.62 • n=105 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=53 Participants
|
27 Participants
n=52 Participants
|
56 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=53 Participants
|
25 Participants
n=52 Participants
|
49 Participants
n=105 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=53 Participants
|
6 Participants
n=52 Participants
|
16 Participants
n=105 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=53 Participants
|
45 Participants
n=52 Participants
|
88 Participants
n=105 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=53 Participants
|
1 Participants
n=52 Participants
|
1 Participants
n=105 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=53 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=53 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=53 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=53 Participants
|
12 Participants
n=52 Participants
|
20 Participants
n=105 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=53 Participants
|
38 Participants
n=52 Participants
|
81 Participants
n=105 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=53 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=53 Participants
|
2 Participants
n=52 Participants
|
2 Participants
n=105 Participants
|
|
Low-density lipoprotein cholesterol (LDL-C)
|
133.83 Milligram per deciliter (mg/dL)
STANDARD_DEVIATION 24.107 • n=53 Participants
|
126.49 Milligram per deciliter (mg/dL)
STANDARD_DEVIATION 28.101 • n=52 Participants
|
130.20 Milligram per deciliter (mg/dL)
STANDARD_DEVIATION 26.294 • n=105 Participants
|
|
Non-high-density lipoprotein cholesterol (non-HDL-C)
|
162.17 mg/dL
STANDARD_DEVIATION 29.664 • n=53 Participants
|
154.31 mg/dL
STANDARD_DEVIATION 32.796 • n=52 Participants
|
158.28 mg/dL
STANDARD_DEVIATION 31.353 • n=105 Participants
|
|
Total Cholesterol (TC)
|
216.68 mg/dL
STANDARD_DEVIATION 28.643 • n=53 Participants
|
206.16 mg/dL
STANDARD_DEVIATION 31.848 • n=52 Participants
|
211.47 mg/dL
STANDARD_DEVIATION 30.586 • n=105 Participants
|
|
Triglycerides (TG)
|
141.57 mg/dL
STANDARD_DEVIATION 60.696 • n=53 Participants
|
138.80 mg/dL
STANDARD_DEVIATION 65.088 • n=52 Participants
|
140.20 mg/dL
STANDARD_DEVIATION 62.621 • n=105 Participants
|
|
High-density lipoprotein cholesterol (HDL-C)
|
54.51 mg/dL
STANDARD_DEVIATION 14.594 • n=53 Participants
|
51.86 mg/dL
STANDARD_DEVIATION 13.097 • n=52 Participants
|
53.20 mg/dL
STANDARD_DEVIATION 13.870 • n=105 Participants
|
|
Very low-density lipoprotein cholesterol (VLDL-C)
|
28.34 mg/dL
STANDARD_DEVIATION 12.114 • n=53 Participants
|
27.82 mg/dL
STANDARD_DEVIATION 13.048 • n=52 Participants
|
28.08 mg/dL
STANDARD_DEVIATION 12.527 • n=105 Participants
|
|
LDL-C by Statin intensity stratum
Moderate-intensity
|
128.91 mg/dL
STANDARD_DEVIATION 18.742 • n=28 Participants • FAS Population.Here, number analyzed signifies those participants who were evaluable in each category.
|
124.54 mg/dL
STANDARD_DEVIATION 28.104 • n=27 Participants • FAS Population.Here, number analyzed signifies those participants who were evaluable in each category.
|
126.76 mg/dL
STANDARD_DEVIATION 23.681 • n=55 Participants • FAS Population.Here, number analyzed signifies those participants who were evaluable in each category.
|
|
LDL-C by Statin intensity stratum
High-intensity
|
139.34 mg/dL
STANDARD_DEVIATION 28.356 • n=25 Participants • FAS Population.Here, number analyzed signifies those participants who were evaluable in each category.
|
128.60 mg/dL
STANDARD_DEVIATION 28.521 • n=25 Participants • FAS Population.Here, number analyzed signifies those participants who were evaluable in each category.
|
133.97 mg/dL
STANDARD_DEVIATION 28.665 • n=50 Participants • FAS Population.Here, number analyzed signifies those participants who were evaluable in each category.
|
|
Apolipoprotein B (ApoB)
|
108.0 mg/dL
STANDARD_DEVIATION 19.61 • n=53 Participants
|
100.1 mg/dL
STANDARD_DEVIATION 22.22 • n=52 Participants
|
104.1 mg/dL
STANDARD_DEVIATION 21.22 • n=105 Participants
|
|
Apolipoprotein A-I (ApoA-I)
|
155.3 mg/dL
STANDARD_DEVIATION 22.14 • n=53 Participants
|
148.8 mg/dL
STANDARD_DEVIATION 25.45 • n=52 Participants
|
152.1 mg/dL
STANDARD_DEVIATION 23.94 • n=105 Participants
|
|
Apolipoprotein A-II (ApoA-II)
|
36.9 mg/dL
STANDARD_DEVIATION 5.38 • n=52 Participants • FAS Population. Here, number analyzed signifies participants with available data.
|
36.0 mg/dL
STANDARD_DEVIATION 5.86 • n=52 Participants • FAS Population. Here, number analyzed signifies participants with available data.
|
36.5 mg/dL
STANDARD_DEVIATION 5.62 • n=104 Participants • FAS Population. Here, number analyzed signifies participants with available data.
|
|
Apolipoprotein C-II (ApoC-II)
|
5.5 mg/dL
STANDARD_DEVIATION 2.45 • n=53 Participants
|
5.5 mg/dL
STANDARD_DEVIATION 2.65 • n=52 Participants
|
5.5 mg/dL
STANDARD_DEVIATION 2.54 • n=105 Participants
|
|
Apolipoprotein C-III (ApoC-III)
|
10.9 mg/dL
STANDARD_DEVIATION 3.40 • n=53 Participants
|
10.7 mg/dL
STANDARD_DEVIATION 3.69 • n=52 Participants
|
10.8 mg/dL
STANDARD_DEVIATION 3.53 • n=105 Participants
|
|
Apolipoprotein E (ApoE)
|
4.3 mg/dL
STANDARD_DEVIATION 0.97 • n=53 Participants
|
4.2 mg/dL
STANDARD_DEVIATION 1.08 • n=52 Participants
|
4.3 mg/dL
STANDARD_DEVIATION 1.02 • n=105 Participants
|
|
High-sensitivity C-reactive protein (hsCRP)
|
2.93 milligram per Liter (mg/L)
STANDARD_DEVIATION 2.792 • n=53 Participants
|
3.91 milligram per Liter (mg/L)
STANDARD_DEVIATION 4.779 • n=52 Participants
|
3.42 milligram per Liter (mg/L)
STANDARD_DEVIATION 3.916 • n=105 Participants
|
|
Fibrinogen
|
453.5 mg/dL
STANDARD_DEVIATION 113.26 • n=53 Participants
|
460.7 mg/dL
STANDARD_DEVIATION 92.22 • n=52 Participants
|
457.1 mg/dL
STANDARD_DEVIATION 102.95 • n=105 Participants
|
|
Lipoprotein(a)
|
104.4 Nanomole per liter (nmol/L)
STANDARD_DEVIATION 123.23 • n=53 Participants
|
113.8 Nanomole per liter (nmol/L)
STANDARD_DEVIATION 102.59 • n=52 Participants
|
109.1 Nanomole per liter (nmol/L)
STANDARD_DEVIATION 113.03 • n=105 Participants
|
|
Adiponectin
|
6.8 Microgram per milliliter (μg/mL)
STANDARD_DEVIATION 4.90 • n=53 Participants
|
6.6 Microgram per milliliter (μg/mL)
STANDARD_DEVIATION 3.98 • n=52 Participants
|
6.7 Microgram per milliliter (μg/mL)
STANDARD_DEVIATION 4.45 • n=105 Participants
|
|
Serum amyloid A
|
5.8 mg/dL
STANDARD_DEVIATION 3.20 • n=53 Participants
|
8.6 mg/dL
STANDARD_DEVIATION 11.01 • n=52 Participants
|
7.2 mg/dL
STANDARD_DEVIATION 816 • n=105 Participants
|
|
Framingham Risk Score
|
18.109 Percentage (%)
STANDARD_DEVIATION 13.8630 • n=53 Participants
|
15.381 Percentage (%)
STANDARD_DEVIATION 11.4957 • n=52 Participants
|
16.758 Percentage (%)
STANDARD_DEVIATION 12.7583 • n=105 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: FAS Population. Missing values were imputed by Last observation carried forward (LOCF).
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in LDL-C at Week 12
|
-16.03 Percent Change
Standard Error 3.234
|
-4.98 Percent Change
Standard Error 3.330
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable in each category.
The intensity of statin therapy was determined based on the statin dose.Participants were categorized as high intensity \& moderate intensity based on their statin doses.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in LDL-C by Statin Intensity Stratum
Moderate intensity
|
-19.58 Percent Change
Standard Error 4.739
|
-8.94 Percent Change
Standard Error 4.766
|
|
Percent Change From Baseline in LDL-C by Statin Intensity Stratum
High intensity
|
-13.05 Percent Change
Standard Error 4.732
|
-1.25 Percent Change
Standard Error 4.943
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in LDL-C
Week 2
|
-25.69 mg/dL
Standard Error 3.731
|
-15.60 mg/dL
Standard Error 3.842
|
|
Change From Baseline in LDL-C
Week 4
|
-20.72 mg/dL
Standard Error 3.958
|
-11.32 mg/dL
Standard Error 4.076
|
|
Change From Baseline in LDL-C
Week 8
|
-17.97 mg/dL
Standard Error 4.172
|
-18.86 mg/dL
Standard Error 4.296
|
|
Change From Baseline in LDL-C
Week 12
|
-20.40 mg/dL
Standard Error 4.059
|
-7.77 mg/dL
Standard Error 4.180
|
|
Change From Baseline in LDL-C
Average of week 8 and 12
|
-19.19 mg/dL
Standard Error 3.717
|
-13.32 mg/dL
Standard Error 3.827
|
SECONDARY outcome
Timeframe: Baseline, average of weeks 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in LDL-C
|
-15.15 Percent Change
Standard Error 2.921
|
-9.27 Percent Change
Standard Error 3.008
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Non-HDL-C
Week 8
|
-12.35 Percent Change
Standard Error 2.831
|
-11.41 Percent Change
Standard Error 2.907
|
|
Percent Change From Baseline in Non-HDL-C
Week 12
|
-14.48 Percent Change
Standard Error 2.860
|
-3.79 Percent Change
Standard Error 2.936
|
|
Percent Change From Baseline in Non-HDL-C
Week 2
|
-17.60 Percent Change
Standard Error 2.397
|
-10.01 Percent Change
Standard Error 2.461
|
|
Percent Change From Baseline in Non-HDL-C
Week 4
|
-13.27 Percent Change
Standard Error 2.664
|
-3.71 Percent Change
Standard Error 2.735
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Non-HDL-C
Week 2
|
-29.21 mg/dL
Standard Error 4.088
|
-16.55 mg/dL
Standard Error 4.197
|
|
Change From Baseline in Non-HDL-C
Week 4
|
-21.88 mg/dL
Standard Error 4.318
|
-6.33 mg/dL
Standard Error 4.433
|
|
Change From Baseline in Non-HDL-C
Week 8
|
-19.45 mg/dL
Standard Error 4.551
|
-18.86 mg/dL
Standard Error 4.673
|
|
Change From Baseline in Non-HDL-C
Week 12
|
-23.21 mg/dL
Standard Error 4.451
|
-6.62 mg/dL
Standard Error 4.570
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in TC
Week 2
|
-14.10 Percent Change
Standard Error 1.923
|
-7.97 Percent Change
Standard Error 1.989
|
|
Percent Change From Baseline in TC
Week 4
|
-10.35 Percent Change
Standard Error 2.136
|
-2.62 Percent Change
Standard Error 2.209
|
|
Percent Change From Baseline in TC
Week 8
|
-8.77 Percent Change
Standard Error 2.236
|
-8.88 Percent Change
Standard Error 2.313
|
|
Percent Change From Baseline in TC
Week 12
|
-9.79 Percent Change
Standard Error 2.161
|
-2.90 Percent Change
Standard Error 2.235
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in TC
Week 2
|
-30.47 mg/dL
Standard Error 4.331
|
-17.73 mg/dL
Standard Error 4.479
|
|
Change From Baseline in TC
Week 4
|
-22.37 mg/dL
Standard Error 4.514
|
-6.08 mg/dL
Standard Error 4.669
|
|
Change From Baseline in TC
Week 8
|
-18.10 mg/dL
Standard Error 4.741
|
-19.68 mg/dL
Standard Error 4.903
|
|
Change From Baseline in TC
Week 12
|
-20.90 mg/dL
Standard Error 4.500
|
-6.92 mg/dL
Standard Error 4.654
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in TG
Week 2
|
-10.58 Percent Change
Standard Error 4.251
|
2.64 Percent Change
Standard Error 4.342
|
|
Percent Change From Baseline in TG
Week 4
|
-6.28 Percent Change
Standard Error 4.706
|
17.31 Percent Change
Standard Error 4.807
|
|
Percent Change From Baseline in TG
Week 8
|
-4.94 Percent Change
Standard Error 3.743
|
1.76 Percent Change
Standard Error 3.823
|
|
Percent Change From Baseline in TG
Week 12
|
-8.22 Percent Change
Standard Error 5.245
|
7.42 Percent Change
Standard Error 5.356
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in TG
Week 2
|
-18.88 mg/dL
Standard Error 6.322
|
0.65 mg/dL
Standard Error 6.457
|
|
Change From Baseline in TG
Week 4
|
-6.08 mg/dL
Standard Error 7.132
|
27.56 mg/dL
Standard Error 7.284
|
|
Change From Baseline in TG
Week 8
|
-8.17 mg/dL
Standard Error 5.238
|
0.16 mg/dL
Standard Error 5.350
|
|
Change From Baseline in TG
Week 12
|
-15.94 mg/dL
Standard Error 10.194
|
13.64 mg/dL
Standard Error 10.412
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in VLDL-C
Week 2
|
-10.55 Percent Change
Standard Deviation 4.104
|
0.97 Percent Change
Standard Deviation 4.192
|
|
Percent Change From Baseline in VLDL-C
Week 4
|
-6.63 Percent Change
Standard Deviation 4.632
|
16.38 Percent Change
Standard Deviation 4.731
|
|
Percent Change From Baseline in VLDL-C
Week 8
|
-4.69 Percent Change
Standard Deviation 3.687
|
1.74 Percent Change
Standard Deviation 3.765
|
|
Percent Change From Baseline in VLDL-C
Week 12
|
-7.69 Percent Change
Standard Deviation 4.155
|
3.94 Percent Change
Standard Deviation 4.243
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in VLDL-C
Week 2
|
-3.64 mg/dL
Standard Error 1.124
|
-0.69 mg/dL
Standard Error 1.148
|
|
Change From Baseline in VLDL-C
Week 4
|
-1.27 mg/dL
Standard Error 1.371
|
5.02 mg/dL
Standard Error 1.400
|
|
Change From Baseline in VLDL-C
Week 8
|
-1.56 mg/dL
Standard Error 1.034
|
0.01 mg/dL
Standard Error 1.056
|
|
Change From Baseline in VLDL-C
Week 12
|
-2.89 mg/dL
Standard Error 1.279
|
1.11 mg/dL
Standard Error 1.306
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in HDL-C
Week 2
|
-2.73 Percent Change
Standard Error 1.771
|
-0.60 Percent Change
Standard Error 1.821
|
|
Percent Change From Baseline in HDL-C
Week 4
|
-0.39 Percent Change
Standard Error 1.888
|
2.01 Percent Change
Standard Error 1.941
|
|
Percent Change From Baseline in HDL-C
Week 8
|
2.34 Percent Change
Standard Error 2.112
|
0.37 Percent Change
Standard Error 2.171
|
|
Percent Change From Baseline in HDL-C
Week 12
|
3.86 Percent Change
Standard Error 2.129
|
1.08 Percent Change
Standard Error 2.189
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in HDL-C
Week 2
|
-1.33 mg/dL
Standard Error 0.964
|
-0.41 mg/dL
Standard Error 0.991
|
|
Change From Baseline in HDL-C
Week 4
|
-0.48 mg/dL
Standard Error 1.004
|
0.65 mg/dL
Standard Error 1.033
|
|
Change From Baseline in HDL-C
Week 8
|
1.35 mg/dL
Standard Error 1.099
|
0.11 mg/dL
Standard Error 1.130
|
|
Change From Baseline in HDL-C
Week 12
|
2.22 mg/dL
Standard Error 1.182
|
0.62 mg/dL
Standard Error 1.216
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants Achieving LDL-C Reduction of ≥10%
Week 4
|
33 Participants
|
22 Participants
|
|
Number of Participants Achieving LDL-C Reduction of ≥10%
Week 8
|
34 Participants
|
29 Participants
|
|
Number of Participants Achieving LDL-C Reduction of ≥10%
Week 12
|
35 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants Achieving LDL-C Reduction of ≥15%
Week 4
|
28 Participants
|
16 Participants
|
|
Number of Participants Achieving LDL-C Reduction of ≥15%
Week 8
|
29 Participants
|
22 Participants
|
|
Number of Participants Achieving LDL-C Reduction of ≥15%
Week 12
|
35 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants Achieving LDL-C Reduction of ≥20%
Week 4
|
25 Participants
|
11 Participants
|
|
Number of Participants Achieving LDL-C Reduction of ≥20%
Week 8
|
19 Participants
|
14 Participants
|
|
Number of Participants Achieving LDL-C Reduction of ≥20%
Week 12
|
22 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)
Week 4
|
21 Participants
|
13 Participants
|
|
Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)
Week 8
|
20 Participants
|
22 Participants
|
|
Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)
Week 12
|
21 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B
Week 4
|
-8.7 Percent Change
Standard Deviation 2.81
|
1.8 Percent Change
Standard Deviation 2.89
|
|
Percent Change From Baseline in Apolipoprotein B
Week 8
|
-9.8 Percent Change
Standard Deviation 2.53
|
-5.5 Percent Change
Standard Deviation 2.60
|
|
Percent Change From Baseline in Apolipoprotein B
Week 12
|
-10.5 Percent Change
Standard Deviation 2.79
|
1.0 Percent Change
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Apolipoprotein B
Week 4
|
-10.6 mg/dL
Standard Deviation 2.74
|
0.1 mg/dL
Standard Deviation 2.82
|
|
Change From Baseline in Apolipoprotein B
Week 8
|
-11.1 mg/dL
Standard Deviation 2.64
|
-7.3 mg/dL
Standard Deviation 2.72
|
|
Change From Baseline in Apolipoprotein B
Week 12
|
-12.0 mg/dL
Standard Deviation 2.86
|
-0.4 mg/dL
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein A-I
Week 12
|
4.7 Percent Change
Standard Deviation 1.60
|
2.8 Percent Change
Standard Deviation 1.66
|
|
Percent Change From Baseline in Apolipoprotein A-I
Week 4
|
3.0 Percent Change
Standard Deviation 1.45
|
3.7 Percent Change
Standard Deviation 1.51
|
|
Percent Change From Baseline in Apolipoprotein A-I
Week 8
|
4.6 Percent Change
Standard Deviation 1.53
|
3.8 Percent Change
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Apolipoprotein A-I
Week 4
|
3.6 mg/dL
Standard Error 2.14
|
4.4 mg/dL
Standard Error 2.22
|
|
Change From Baseline in Apolipoprotein A-I
Week 8
|
6.5 mg/dL
Standard Error 2.36
|
4.8 mg/dL
Standard Error 2.45
|
|
Change From Baseline in Apolipoprotein A-I
Week 12
|
6.9 mg/dL
Standard Error 2.50
|
3.3 mg/dL
Standard Error 2.59
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
Outcome measures
| Measure |
Gemcabene 600 mg
n=52 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein A-II
Week 4
|
2.1 Percent Change
Standard Error 1.49
|
1.9 Percent Change
Standard Error 1.54
|
|
Percent Change From Baseline in Apolipoprotein A-II
Week 8
|
3.8 Percent Change
Standard Error 1.84
|
-1.4 Percent Change
Standard Error 1.90
|
|
Percent Change From Baseline in Apolipoprotein A-II
Week 12
|
3.7 Percent Change
Standard Error 1.80
|
-0.9 Percent Change
Standard Error 1.86
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.
Outcome measures
| Measure |
Gemcabene 600 mg
n=52 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Apolipoprotein A-II
Week 8
|
1.1 mg/dL
Standard Error 0.69
|
-0.8 mg/dL
Standard Error 0.71
|
|
Change From Baseline in Apolipoprotein A-II
Week 12
|
0.9 mg/dL
Standard Error 0.66
|
-0.7 mg/dL
Standard Error 0.68
|
|
Change From Baseline in Apolipoprotein A-II
Week 4
|
0.5 mg/dL
Standard Error 0.54
|
0.4 mg/dL
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein C-II
Week 4
|
20.0 Percent Change
Standard Error 5.34
|
13.1 Percent Change
Standard Error 5.46
|
|
Percent Change From Baseline in Apolipoprotein C-II
Week 8
|
30.7 Percent Change
Standard Error 6.95
|
3.9 Percent Change
Standard Error 7.10
|
|
Percent Change From Baseline in Apolipoprotein C-II
Week 12
|
27.3 Percent Change
Standard Error 7.07
|
7.2 Percent Change
Standard Error 7.23
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Apolipoprotein C-II
Week 4
|
0.5 mg/dL
Standard Error 0.19
|
0.00 mg/dL
Standard Error 0.20
|
|
Change From Baseline in Apolipoprotein C-II
Week 8
|
0.8 mg/dL
Standard Error 0.24
|
-0.3 mg/dL
Standard Error 0.25
|
|
Change From Baseline in Apolipoprotein C-II
Week 12
|
0.8 mg/dL
Standard Error 0.27
|
0.00 mg/dL
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein C-III
Week 4
|
0.4 Percent Change
Standard Error 3.61
|
12.6 Percent Change
Standard Error 3.69
|
|
Percent Change From Baseline in Apolipoprotein C-III
Week 8
|
2.0 Percent Change
Standard Error 3.56
|
1.8 Percent Change
Standard Error 3.64
|
|
Percent Change From Baseline in Apolipoprotein C-III
Week 12
|
3.5 Percent Change
Standard Error 4.32
|
9.7 Percent Change
Standard Error 4.42
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Apolipoprotein C-III
Week 4
|
0.0 mg/dL
Standard Deviation 0.39
|
1.4 mg/dL
Standard Deviation 0.40
|
|
Change From Baseline in Apolipoprotein C-III
Week 8
|
0.0 mg/dL
Standard Deviation 0.38
|
0.0 mg/dL
Standard Deviation 0.38
|
|
Change From Baseline in Apolipoprotein C-III
Week 12
|
0.3 mg/dL
Standard Deviation 0.44
|
0.9 mg/dL
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein E
Week 4
|
-6.7 Percent Change
Standard Error 2.86
|
9.1 Percent Change
Standard Error 2.94
|
|
Percent Change From Baseline in Apolipoprotein E
Week 8
|
-7.3 Percent Change
Standard Error 2.89
|
-0.1 Percent Change
Standard Error 2.97
|
|
Percent Change From Baseline in Apolipoprotein E
Week 12
|
-7.8 Percent Change
Standard Error 3.16
|
7.5 Percent Change
Standard Error 3.25
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Apolipoprotein E
Week 4
|
-0.3 mg/dL
Standard Error 0.11
|
0.3 mg/dL
Standard Error 0.12
|
|
Change From Baseline in Apolipoprotein E
Week 8
|
-0.3 mg/dL
Standard Error 0.12
|
-0.1 mg/dL
Standard Error 0.13
|
|
Change From Baseline in Apolipoprotein E
Week 12
|
-0.4 mg/dL
Standard Error 0.15
|
0.3 mg/dL
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a)
Week 4
|
3.5 Percent Change
Standard Error 4.61
|
-5.1 Percent Change
Standard Error 4.72
|
|
Percent Change From Baseline in Lipoprotein(a)
Week 8
|
3.9 Percent Change
Standard Error 3.94
|
-4.0 Percent Change
Standard Error 4.03
|
|
Percent Change From Baseline in Lipoprotein(a)
Week 12
|
4.2 Percent Change
Standard Error 5.18
|
0.1 Percent Change
Standard Error 5.30
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8 and 12Population: FAS Population. Missing values were imputed by LOCF.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Lipoprotein(a)
Week 4
|
-1.9 nmol/L
Standard Error 3.97
|
-3.6 nmol/L
Standard Error 4.06
|
|
Change From Baseline in Lipoprotein(a)
Week 8
|
2.1 nmol/L
Standard Error 3.16
|
-2.6 nmol/L
Standard Error 3.23
|
|
Change From Baseline in Lipoprotein(a)
Week 12
|
2.1 nmol/L
Standard Error 4.00
|
1.7 nmol/L
Standard Error 4.09
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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
| Measure |
Gemcabene 600 mg
n=51 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=51 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in High-sensitivity C-reactive Protein
|
57.33 Percent Change
Standard Error 64.525
|
24.76 Percent Change
Standard Error 66.946
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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
| Measure |
Gemcabene 600 mg
n=51 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=51 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in High-sensitivity C-reactive Protein
|
-0.40 mg/L
Standard Deviation 0.495
|
0.44 mg/L
Standard Deviation 0.513
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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
| Measure |
Gemcabene 600 mg
n=51 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=51 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Fibrinogen
|
61.8 Percent Change
Standard Error 47.59
|
20.3 Percent Change
Standard Error 48.69
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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
| Measure |
Gemcabene 600 mg
n=51 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=51 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Fibrinogen
|
9.0 mg/dL
Standard Error 13.69
|
41.4 mg/dL
Standard Error 14.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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
| Measure |
Gemcabene 600 mg
n=51 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=51 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Serum Amyloid A
|
34.6 Percent Change
Standard Error 69.71
|
44.1 Percent Change
Standard Error 71.04
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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
| Measure |
Gemcabene 600 mg
n=51 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=51 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Serum Amyloid A
|
-0.5 mg/dL
Standard Error 2.87
|
2.6 mg/dL
Standard Error 2.93
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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
| Measure |
Gemcabene 600 mg
n=51 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=50 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Adiponectin
|
17.7 Percent Change
Standard Error 4.10
|
5.4 Percent Change
Standard Error 4.26
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 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
| Measure |
Gemcabene 600 mg
n=51 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=50 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Adiponectin
|
1.2 μg/mL
Standard Deviation 0.32
|
0.4 μg/mL
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS Population. Missing values were imputed by LOCF.
Framingham Risk Score was an estimate of a participant's 10-year risk of developing cardiovascular disease which was computed using sex-specific algorithms based on total point score (range less than negative 3 \[best\] to greater than or equal to 14 \[worst\] for men; less than or equal to negative 2 \[best\] and greater than or equal to 17 \[worst\] for women) : which was derived of participant's age, systolic blood pressure , smoking status, TC, HDL-C, treatment for hypertension, and diabetes status. Reported score is a percentage. Change from baseline calculated as mean at week 12 minus mean at baseline. Negative scores indicate less risk of developing cardiovascular disease.
Outcome measures
| Measure |
Gemcabene 600 mg
n=53 Participants
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=52 Participants
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Framingham Risk Score
|
-2.051 Percentage (%)
Standard Deviation 4.1599
|
-0.850 Percentage (%)
Standard Deviation 4.9889
|
Adverse Events
Gemcabene 600 mg
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gemcabene 600 mg
n=54 participants at risk
Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
|
Placebo
n=51 participants at risk
Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Eye disorders
Retinal cyst
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
General disorders
Fatigue
|
5.6%
3/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
General disorders
Oedema
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
General disorders
Peripheral swelling
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
General disorders
Oedema peripheral
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.8%
8/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
7.8%
4/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
5/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
3/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Bronchitis
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Cellulitis
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Gastroenteritis viral
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Influenza
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
3.9%
2/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Tooth abscess
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Investigations
Immunology test abnormal
|
5.6%
3/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.7%
2/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Investigations
Glomerular filtration rate decreased
|
3.7%
2/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Investigations
Haemoglobin decreased
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Investigations
Red blood cell count decreased
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
3.7%
2/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
3.9%
2/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
3.9%
2/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Nervous system disorders
Dizziness
|
3.7%
2/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Nervous system disorders
Headache
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Nervous system disorders
Hypogeusia
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Nervous system disorders
Tension headache
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Psychiatric disorders
Panic attack
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Renal and urinary disorders
Albuminuria
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Renal and urinary disorders
Proteinuria
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.9%
1/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
0.00%
0/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
|
Vascular disorders
Flushing
|
0.00%
0/54 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
2.0%
1/51 • Baseline to end of study (Up to 113 days)
One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.
|
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