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

NCT02532218 | Unknown Phase 2

• 1 other identifier: ARI-3037MO-005
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• LDL-c

  change in LDL cholesterol level

  24 wks

Secondary Outcomes (3)

• HDL-c

  24 wks

• TG

  24 wks

• HbA1C

  24 wks

Study Arms (2)

Active

ACTIVE COMPARATOR

ARI-3037MO (niacin analog) 3g bid for 24 wks

Drug: ARI-3037MO

Placebo

PLACEBO COMPARATOR

Matching Placebo 3g bid for 24 wks

Drug: ARI-3037MO

Interventions

ARI-3037MO DRUG

Lipid lowering treatment Statins

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Arisaph Pharmaceuticals Inc: lead

Study Sites (19)

Catalina Reserch Institute, LLC

Chino, California, 91710, United States

Location

S&W Clinical Reserch

Fort Lauderdale, Florida, 33306, United States

Location

Jacksonville Center for Clinical Research

Jacksonvile, Florida, 32216, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Sestron Clinical Research 833 Campbell Hill Street Suite 230

Marietta, Georgia, 30060, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Louisville Metabolic and Atherosclerosis Research Center

Louisville, Kentucky, 40213, United States

Location

Rochester clinical Research,Inc

Rochester, New York, 14069, United States

Location

Sterling Research Group Ltd

Cincinnati, Ohio, 45219, United States

Location

The Carl and Edyth Lindner Center for Reserch and education at the Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Metabolic and atherosclerosis Research center

Cincinnati, Ohio, 45227, United States

Location

IVA reserch

Cincinnati, Ohio, 45245, United States

Location

Sterling Research group, Ltd

Cincinnati, Ohio, 45246, United States

Location

Ohio Clinical Research-Lyndhurst

Lyndhurst, Ohio, 44124, United States

Location

COR Clinical Research

Oklahoma City, Oklahoma, 73103, United States

Location

Willamette Valley Clinical studies

Eugene, Oregon, 97404, United States

Location

Health Research of Hampton Roads - Norfolk

Norfolk, Virginia, 23502, United States

Location

National Clinical Research inc

Richmond, Virginia, 23294, United States

Location

Raninier Clinical Reserach

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 25, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2015-09

Locations

US (19)