Evaluation of ARI-3037MO, to Suppress LDL Cholesterol in Patients With Dyslipidemia

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

The objective of this study is to evaluate the efficacy and safety of ARI-3037MO compared to placebo in reducing low-density lipoprotein cholesterol (LDL-C) levels in subjects with dyslipidemia.

Key facts

Study ID: NCT02532218
Run by: Arisaph Pharmaceuticals Inc
People needed: 176
Starts: 2015-08-01
Expected to finish: 2016-12-01
Last updated by the study team: 2016-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years at screening.
Women of childbearing potential, must agree to use 2 medically accepted, effective methods of birth control. Females who are postmenopausal must have been postmenopausal for > 1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subject's follicle-stimulating hormone level must be elevated and consistent with postmenopausal levels (i.e., > 40 IU/L); otherwise these subjects must agree to use contraceptives listed above.
Male subjects with sexual partners of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening through 12 weeks after last dose of study drug to prevent pregnancy in a partner.
Female subjects of childbearing potential (including females with questionable postmenopausal status) must have a negative pregnancy test prior to dosing.
LDL-C level: ≥ 100 mg/dL.
Triglycerides (TG) ≤ 300 mg/dL.
High-density lipoprotein cholesterol (HDL-C) level < 45 mg/dL in men and < 50 mg/dL in women.
Subject understands the trial requirements and the treatment procedures, is willing to comply with all protocol-required follow-up evaluation and provides written informed consent
Subjects will be managed according to current standard of care. Subjects taking statin therapy will remain on their statin background therapy and must be on a stable dose, defined as no changes in the dose of statin in the 3 months prior to screening, and must be willing and able to remain on that dose for the duration of the study.

You may not qualify if…

Subjects treated with any statin at its maximally approved dose will be excluded from the study.
Body mass index (BMI) > 45 kg/m2.
Weight change ≥ 3 kg during the lead-in period.
Uncontrolled diabetes, defined as glycosylated hemoglobin (HbA1C) > 9.5%.
Contraindication to niacin treatment (prior flushing is not regarded as a contraindication to niacin treatment).
History of stroke, myocardial infarction, life-threatening arrhythmia, or having had coronary vascularization within 6 months before screening.
Thyroid-stimulating hormone ≥ 1.5 times the upper limit of normal (ULN).
Clinical evidence of hypothyroidism or thyroid hormonal therapy that has not been stable for ≥ 6 weeks before screening.
Creatine kinase concentration ≥ 3 times the ULN.
Known, active liver disease, including but not limited to
Confirmed alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase ≥ 2 times the ULN, or bilirubin ≥ 1.5 times the ULN.
Hepatitis C (anti-hepatitis C virus immunoglobulin G +).
Hepatitis B (hepatitis B surface antigen +, anti-hepatitis B core antigen immunoglobulin M +).
Blood donation of ≥ 1 pint (0.5 L) within 30 days before screening or plasma donation within 7 days before screening.
Known nephrotic syndrome or ≥ 3 g/day proteinuria.
Past organ transplant or on a waiting list for an organ transplant.
Subject is currently receiving chemotherapy; or has received chemotherapy within the 30 days prior to screening; or is scheduled to receive chemotherapy during the course of the study.
Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months.
Problems with substance abuse, which, in the opinion of the Investigator, might affect study compliance.
Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
Participation in another investigational drug trial in the past 30 days or current participation in a device trial that has not reached its primary endpoint.
Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study or within 12 weeks after last dose of study drug.
Estimated glomerular filtration rate < 60 mL/min/1.73 m2. -

Where it is running

Catalina Reserch Institute, LLC — Chino, California, United States
S&W Clinical Reserch — Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research — Jacksonvile, Florida, United States
Progressive Medical Research — Port Orange, Florida, United States
Sestron Clinical Research 833 Campbell Hill Street Suite 230 — Marietta, Georgia, United States
Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
Louisville Metabolic and Atherosclerosis Research Center — Louisville, Kentucky, United States
Rochester clinical Research,Inc — Rochester, New York, United States
Sterling Research Group Ltd — Cincinnati, Ohio, United States
The Carl and Edyth Lindner Center for Reserch and education at the Christ Hospital — Cincinnati, Ohio, United States
Metabolic and atherosclerosis Research center — Cincinnati, Ohio, United States
IVA reserch — Cincinnati, Ohio, United States
Sterling Research group, Ltd — Cincinnati, Ohio, United States
Ohio Clinical Research-Lyndhurst — Lyndhurst, Ohio, United States
COR Clinical Research — Oklahoma City, Oklahoma, United States
Willamette Valley Clinical studies — Eugene, Oregon, United States
Health Research of Hampton Roads - Norfolk — Norfolk, Virginia, United States
National Clinical Research inc — Richmond, Virginia, United States
Raninier Clinical Reserach — Renton, Washington, United States

Full record on ClinicalTrials.gov

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