A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterol... | NCT02634151

NCT02634151

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.	Drug: Placebo
Gemcabene 600 mg	Experimental	Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.	Drug: Gemcabene

Name	Type	Description	Arm Group Labels	Other Names
Gemcabene	Drug	Two 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks.	Gemcabene 600 mg

Outcomes Module

Measure	Description	Time Frame
Percent Change From Baseline in LDL-C at Week 12		Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in LDL-C by Statin Intensity Stratum	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.	Baseline, Week 12
Change From Baseline in LDL-C

Eligibility Module

Eligibility Criteria

Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedures;
Male or female (neither pregnant or lactating) ≥ 18 years of age at the time of consent;
Currently on a stable, low-fat, low-cholesterol diet in combination with allowed statin doses as described in Table 1, with or without ezetimibe 10 mg QD for at least 12 weeks prior to the Screening Visit;
Fasting LDL-C value ≥ 100 mg/dL (2.59 mmol/L) at the Screening Visit;
Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;
Weight ≥ 50 kg; with a body mass index (BMI) ≤ 45 kg/m2
Subjects with Type 2 diabetes who take anti-hyperglycemic agents must be on a stable regimen for at least 3 months, with no planned changes in medications for the study duration.

Exclusion Criteria

Abnormal liver function test at the Pre-Screening or Screening Visit (AST or ALT) > 2x ULN (upper limit of normal), total bilirubin > 1.5x ULN, or alkaline phosphate > 2x ULN based on appropriate age and gender normal values. Subjects with bilirubin > 1.5x ULN and a history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;
Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the Child-Pugh classification;
Active liver disease (e.g. cirrhosis, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of HIV or AIDS;
Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;
Moderate to severe renal insufficiency define as an estimated GFR < 60mL/min/1.73m (calculated using the Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or Screening Visit;
Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria) confirmed by reflexive urine protein:creatinine ration testing;
Uncontrolled thyroid disease; hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal or > 1.5x ULN, respectively, based on results from the Pre-Screening Visit or the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to Screening;
Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (hemoglobin A1c value > 8.5% based on results from the Pre-Screening or Screening Visit, or taking a thiazolidinedione (i.e. pioglitazone or rosiglitazone);
New York Heart Association Class III or IV heart failure;
Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or other major cardiovascular events resulting in hospitalization within 3 months of the Screening Visit. Subjects with adequately treated stable angina, per Investigator assessment, may be included;
Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Day 1 prior to dosing ECG (QTcF > 450 msec for men and > 470 msec for women) or known family history of prolonged QT or unexplained sudden cardiac death;
Uncontrolled hypertension, defined as sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg, and confirmed by repeat measurement;
Currently receiving cancer treatments or, in the Investigator's opinion, at risk of relapse for recent cancer;
Inadequate wash-out of a PCSK9 inhibitor (8 weeks prior to the Screening Visit), a fibrate lipid-regulating agent (6 weeks prior to the Screening Visit), niacins (4 weeks prior to the Screening Visit), or other lipid-regulating therapies such as bile acid sequestrants (4 weeks prior to the Screening Visit);
Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid-regulating agent;
Use of any excluded medications or supplements (e.g. potent cytochrome P450 [CYP] 3A4 inhibitors as described in Appendix D;
History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subjects restrictions (see Section 5.6.3);
Previously treated with gemcabene (CI-1027), participation in another clinical study of an investigational agent or device concurrently or within 1 month prior the Screening Visit, or use of an investigational agent within 1 month or 5 half-lives (if known), whichever is longer, prior to the Screening Visit;
Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Central Research Associates, Inc.		Birmingham	Alabama	35205	United States
Westside Medical Associates of Los Angeles

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.
FG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jul 10, 2017	May 14, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Full Analysis Set (FAS): All randomized participants who received at least 1 dose of the study drug and had at least 1 post-baseline efficacy assessment.

Arm/Group Information

ID	Title	Description
BG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
BG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-16.03± 3.234 OG001-4.98± 3.330

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A 2-sided test with a significance level of 0.05 was used for the comparison.	ANCOVA	Randomized treatment group, baseline statin intensity, & diabetes status are included as factors, & outcome at baseline is included as a covariate.	0.0057		LS Mean Difference	-11.05			2-Sided	95	-18.81	-3.29					Superiority

Secondary

Percent Change From Baseline in LDL-C by Statin Intensity Stratum

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.

FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable in each category.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in LDL-C

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in LDL-C

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, average of weeks 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Non-HDL-C

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Non-HDL-C

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in TC

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in TC

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in TG

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in TG

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in VLDL-C

FAS Population. Missing values were imputed by LOCF.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in VLDL-C

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in HDL-C

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in HDL-C

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving LDL-C Reduction of ≥10%

FAS Population. Missing values were imputed by LOCF.

Posted

Count of Participants

Participants

Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving LDL-C Reduction of ≥15%

FAS Population. Missing values were imputed by LOCF.

Posted

Count of Participants

Participants

Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving LDL-C Reduction of ≥20%

FAS Population. Missing values were imputed by LOCF.

Posted

Number

Participants

Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)

FAS Population. Missing values were imputed by LOCF.

Posted

Count of Participants

Participants

Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B

FAS Population. Missing values were imputed by LOCF.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Apolipoprotein B

FAS Population. Missing values were imputed by LOCF.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein A-I

FAS Population. Missing values were imputed by LOCF.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Apolipoprotein A-I

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein A-II

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Apolipoprotein A-II

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein C-II

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Apolipoprotein C-II

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein C-III

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Apolipoprotein C-III

FAS Population. Missing values were imputed by LOCF.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein E

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Apolipoprotein E

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Lipoprotein(a)

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Lipoprotein(a)

FAS Population. Missing values were imputed by LOCF.

Posted

Least Squares Mean

Standard Error

nmol/L

Baseline, Weeks 4, 8 and 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in High-sensitivity C-reactive Protein

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in High-sensitivity C-reactive Protein

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

mg/L

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Fibrinogen

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fibrinogen

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Serum Amyloid A

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Amyloid A

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Adiponectin

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Adiponectin

FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

μg/mL

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Framingham Risk Score

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.

FAS Population. Missing values were imputed by LOCF.

Posted

Mean

Standard Deviation

Percentage (%)

Baseline, Week 12

ID	Title	Description
OG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.
OG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gemcabene 600 mg	Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.	0	54	0	54	33	54
EG001	Placebo	Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.	0	51	0	51	24	51

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Retinal cyst	Eye disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Flatulence	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Toothache	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Fatigue	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected54 at risk EG0011 affected51 at risk
Oedema	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Peripheral swelling	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Non-cardiac chest pain	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Oedema peripheral	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0008 affected54 at risk EG0014 affected51 at risk
Nasopharyngitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0005 affected54 at risk EG0010 affected51 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected54 at risk EG0011 affected51 at risk
Bronchitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Cellulitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Influenza	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0011 affected51 at risk
Sinusitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0012 affected51 at risk
Tooth abscess	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Diverticulitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Pneumonia	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Immunology test abnormal	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0003 affected54 at risk EG0011 affected51 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected54 at risk EG0010 affected51 at risk
Glomerular filtration rate decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected54 at risk EG0010 affected51 at risk
Haemoglobin decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Red blood cell count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
White blood cells urine positive	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected54 at risk EG0010 affected51 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Joint crepitation	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0011 affected51 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0012 affected51 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0012 affected51 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Dizziness	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 affected54 at risk EG0010 affected51 at risk
Headache	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0011 affected51 at risk
Hypogeusia	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Tension headache	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Sinus headache	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Panic attack	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Albuminuria	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Proteinuria	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Urine abnormality	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0011 affected51 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0011 affected51 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 affected54 at risk EG0010 affected51 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk
Flushing	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 affected54 at risk EG0011 affected51 at risk

ID	Term
D006937	Hypercholesterolemia

ID	Term
C111024	gemcabene

ParticipantsBG002105

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases