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



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/26/2017
Start Date:November 2016
End Date:August 2017

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A 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy

The purpose of this study is to assess the efficacy, safety, and tolerability of multiple
doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not
adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients
with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100
mg/dL. Subjects will be randomized 1:1 to gemcabene 600 mg QD or placebo.


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.
We found this trial at
23
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907 Floyd Avenue
Richmond, Virginia 23284
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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5503 South Congress Avenue
Atlantis, Florida 33462
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Beverly Hills, California 90211
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Birmingham, Alabama 35205
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Boca Raton, Florida 33434
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Cincinnati, Ohio 45219
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Evanston, Illinois 60201
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Houston, Texas 77027
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Huntington Park, California 90255
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Indianapolis, Indiana 46260
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Jupiter, Florida 33458
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Lansdale, Pennsylvania 19446
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Louisville, Kentucky 40213
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Maitland, Florida 32751
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New Windsor, New York 12553
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Port Orange, Florida 32127
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Rochester, New York 14609
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4410 Medical Drive
San Antonio, Texas 78229
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Sugar Land, Texas 77479
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10840 Sheldon Road
Tampa, Florida 33626
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