A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol Levels
Condition: Type II Hyperlipidemia
MeSH terms: Hyperlipoproteinemia Type II; Hyperlipidemias; Hyperlipoproteinemias
Intervention: DRL-17822 or placebo
Intervention description: DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Randomized; Double-Blind; Placebo Controlled; Parallel Arm; Type II Hyperlipidemia; Cholesteryl Ester Transferase Protein Inhibitor; CETP Inhibitor

Summary:

      The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in
      elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein
      cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for
      heart disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Type II hyperlipidemia having lipid values of HDL-C: males ≤ 44 mg/dL
             (≤1.13 mmol/L), females ≤ 54 mg/dL (≤1.39 mmol/L); LDL-C: ≥ 130 mg/dL (≥3.33 mmol/L);

          -  Male or female, 18 to 70 years of age, inclusive. Female patients must be
             postmenopausal or surgically sterile. Men, unless surgically sterile must practice
             birth control from screening until the end of the study;

          -  Ability and willingness to give written informed consent;

          -  No clinically significant abnormal findings on medical history, physical examination,
             vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory profiles of both
             blood and urine.

        Exclusion Criteria:

          -  Patients with significant cardiac disease such as myocardial infarction, heart
             failure, coronary or peripheral artery angioplasty, bypass graft surgery, severe or
             unstable angina pectoris, cardiac arrhythmias, hypertension or any other disease which
             requires treatment;

          -  Uncontrolled diabetes (HbA1c > 8.0%);

          -  History of symptomatic cerebrovascular disease such as symptomatic carotid artery
             disease, cerebrovascular hemorrhage, transient ischemic attack or carotid
             endarterectomy or any disease which requires treatment;

          -  History of clinically significant hematologic, renal, hepatic, neurologic, endocrine,
             oncologic, pulmonary, immunologic or psychiatric disorders;

          -  Any current or recent (within 4 weeks of run-in) concomitant therapy (apart from
             paracetamol/acetaminophen and non-steroidal anti-inflammatory drugs [NSAIDs]).
             Patients on previous concomitant treatment may enter the study if the treatment has
             been discontinued, when appropriate and if ethically justified, at least four weeks
             prior to run-in;

          -  Body mass index (BMI)> 35 kg/m(2);

          -  Positive for hepatitis B, C or HIV or known history or concurrent tuberculosis;

          -  Positive drug screen result (i.e., cocaine, opiates, amphetamine, cannabis,
             barbiturates, benzodiazepines and/or metadone);

          -  Pregnant, breast feeding or women of child-bearing potential;

          -  Regular use of non-drug therapies such as garlic supplements and St. John's Wort;

          -  Presence or history of alcoholism or drug abuse;

          -  Use of more than 21 units of alcohol per week for males or more than 14 units per week
             for females;

          -  Smoking within 3 months prior to screening;

          -  Relevant drug hypersensitivity or allergy or any serious adverse event reaction to
             lipid regulating agents;

          -  Administration of study drug in another drug study within 90 days prior to enrollment
             or participation in another drug trial from screening to last follow-up of this study;
             Any surgical or medical condition which makes the patient unsuitable to participate in
             the opinion of the Investigator.