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

NCT02634151 | Completed Phase 2 Results

• 1 other identifier: GEM-301
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 24

Brief Summary

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.

Conditions

Hypercholesteremia

Keywords

LDL-C; Lipid Regulator

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in LDL-C at Week 12

  Baseline, Week 12

Secondary Outcomes (40)

• Percent Change From Baseline in LDL-C by Statin Intensity Stratum

  Baseline, Week 12

• Change From Baseline in LDL-C

  Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12

• Percent Change From Baseline in LDL-C

  Baseline, average of weeks 8 and 12

• Percent Change From Baseline in Non-HDL-C

  Baseline, Weeks 2, 4, 8 and 12

• Change From Baseline in Non-HDL-C

  Baseline, Weeks 2, 4, 8 and 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.

Drug: Placebo

Gemcabene 600 mg

EXPERIMENTAL

Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.

Drug: Gemcabene

Interventions

Gemcabene DRUG

Two 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks.

Gemcabene 600 mg

Placebo DRUG

Three placebo tablets administered orally once daily for 12 weeks.

Placebo

Eligibility Criteria

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

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;

Sponsors & Collaborators

• NeuroBo Pharmaceuticals Inc.: lead

Study Sites (24)

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

Westside Medical Associates of Los Angeles

Beverly Hills, California, 90211, United States

Location

National Research Institute

Huntington Park, California, 90255, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Atlantic Clinical Research Collaborative- Cardiology

Atlantis, Florida, 33462, United States

Location

Excel Medical Clinical Trials

Boca Raton, Florida, 33434, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Meridien Research, Inc.

Maitland, Florida, 32751, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Varkey Medical

Tampa, Florida, 33626, United States

Location

Evanston Premier Healthcare Research, LLC

Evanston, Illinois, 60201, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

L-MARC

Louisville, Kentucky, 40213, United States

Location

Mid-Hudson Medical Research

New Windsor, New York, 12553, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45219, United States

Location

Sentral Clinical Research Services

Cincinnati, Ohio, 45236, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45246, United States

Location

Green and Seidner Family Practice Associates

Lansdale, Pennsylvania, 19446, United States

Location

Associates in Medicine

Houston, Texas, 77027, United States

Location

Diagnostics Research Grup

San Antonio, Texas, 78229, United States

Location

Sugar Lakes Family Practice

Sugar Land, Texas, 77479, United States

Location

National Research Institute

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

gemcabene

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Vice President Clinical Operations
• Organization: NeuroBo Pharmaceuticals

info@neurobopharma.com

+1 (857) 702-9600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: December 11, 2015
• First Posted: December 17, 2015
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 25, 2020
• Results First Posted: June 25, 2020

Record last verified: 2020-06

Locations

US (24)