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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesteremia

In brief

The purpose of this study was 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 were randomized 1:1 to gemcabene 600 mg once daily (QD) or placebo.

Key facts

Study ID

NCT02634151

Run by

NeuroBo Pharmaceuticals Inc.

People needed

105

Starts

2016-11-01

Expected to finish

2017-08-01

Last updated by the study team

2020-06-25

Who can join

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

You may not qualify if…

• 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; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;
• Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the Child-Pugh classification;
• Active liver disease (e.g. cirrhosis, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of HIV or AIDS;
• Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;
• 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;
• 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;
• 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;
• 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);
• New York Heart Association Class III or IV heart failure;
• 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;
• 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;
• Uncontrolled hypertension, defined as sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg, and confirmed by repeat measurement;
• Currently receiving cancer treatments or, in the Investigator's opinion, at risk of relapse for recent cancer;
• 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);
• Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid-regulating agent;
• Use of any excluded medications or supplements (e.g. potent cytochrome P450 [CYP] 3A4 inhibitors as described in Appendix D;
• History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subjects restrictions (see Section 5.6.3);
• 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;
• Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study.

Where it is running

• Central Research Associates, Inc. — Birmingham, Alabama, United States
• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States
• National Research Institute — Huntington Park, California, United States
• National Research Institute — Los Angeles, California, United States
• Atlantic Clinical Research Collaborative- Cardiology — Atlantis, Florida, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Meridien Research, Inc. — Maitland, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Varkey Medical — Tampa, Florida, United States
• Evanston Premier Healthcare Research, LLC — Evanston, Illinois, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• L-MARC — Louisville, Kentucky, United States
• Mid-Hudson Medical Research — New Windsor, New York, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• Sterling Research Group, Ltd. — Cincinnati, Ohio, United States
• Sentral Clinical Research Services — Cincinnati, Ohio, United States
• Sterling Research Group, Ltd. — Cincinnati, Ohio, United States
• Green and Seidner Family Practice Associates — Lansdale, Pennsylvania, United States
• Associates in Medicine — Houston, Texas, United States
• Diagnostics Research Grup — San Antonio, Texas, United States
• Sugar Lakes Family Practice — Sugar Land, Texas, United States
• National Research Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.