A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins

1. Provision of written and signed informed consent (by subject or legal guardian) prior
to any study-specific procedures;

2. Male or female (neither pregnant or lactating) ≥ 18 years of age at the time of
consent;

3. Currently on a stable, low-fat, low-cholesterol diet in combination with allowed
statin doses as described in Table 1, with or without ezetemibe 10 mg QD for at least
12 weeks prior to the Screening Visit;

4. Fasting LDL-C value ≥ 100 mg/dL (2.59 mmol/L) at the Screening Visit;

5. Physical examination, including vital signs, that is within normal limits or
clinically acceptable to the Investigator;

6. Weight ≥ 50 kg; with a body mass index (BMI) ≤ 45 kg/m2

7. 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

1. 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; relfexive direct bilirubin
testing will be used to confirm Gilbert's syndrome;

2. Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the
Child-Pugh classification;

3. Active liver disease (e.g. cirrhosis, alcoholic liver disease, hepatitis B, hepatitis
C, automimmune hepatitis, liver failure, liver cancer), history of liver transplant,
known diagnosis of HIV or AIDS;

4. Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;

5. 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;

6. 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;

7. 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;

8. 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);

9. New York Heart Association Class III or IV heart failure;

10. 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;

11. 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;

12. Uncontrolled hypertension, defined as sitting systolic blood pressure > 180 mmHg or
diastolic blood pressure > 110 mmHg, and confirmed by repeat measurement;

13. Currently receiving cancer treatments or, in the Investigator's opinion, at risk of
relapse for recent cancer;

14. 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);

15. Hypersensitivity to or a history of significant adverse reactions to any fibrate
lipid-regulating agent;

16. Use of any excluded medications or supplements (e.g. potent cytochrome P450 [CYP] 3A4
inhibitors as described in Appendix D;

17. History of drug or alcohol abuse within the past year or inabilty to comply with
protocol requirements, including subjects restrictions (see Section 5.6.3);

18. 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;

19. Any other finding which, in the opinion of the Investigator, would compromise the
subject's safety or participation in the study.