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A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins (ROYAL-1)

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Gemphire Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02634151
First received: December 11, 2015
Last updated: November 14, 2016
Last verified: November 2016
  Purpose
The purpose of this study is 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 will be randomized 1:1 to gemcabene 600 mg QD or placebo.

Condition Intervention Phase
Hypercholesteremia Drug: Gemcabene 600 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy

Resource links provided by NLM:


Further study details as provided by Gemphire Therapeutics, Inc.:

Primary Outcome Measures:
  • LDL-C [ Time Frame: Baseline and 84 days (12 weeks) ]
    % change from baseline


Estimated Enrollment: 104
Study Start Date: November 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo treatment on stable background statin therapy
Drug: Placebo
Placebo, 3 tabs QD, 84 days
Experimental: Gemcabene 600 mg QD
Gemcabene treatment on stable background statin therapy
Drug: Gemcabene 600 mg
2-300 mg tablets, 1 placebo tablet, QD, 84 days

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedures;
  2. Male or female (neither pregnant or lactating) ≥ 18 years of age at the time of consent;
  3. Currently on a stable, low-fat, low-cholesterol diet in combination with allowed statin doses as described in Table 1, with or without ezetemibe 10 mg QD for at least 12 weeks prior to the Screening Visit;
  4. Fasting LDL-C value ≥ 100 mg/dL (2.59 mmol/L) at the Screening Visit;
  5. Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;
  6. Weight ≥ 50 kg; with a body mass index (BMI) ≤ 45 kg/m2
  7. Subjects with Type 2 diabetes who take anti-hyperglycemic agents must be on a stable regimen for at least 3 months, with no planned changes in medications for the study duration.

Exclusion Criteria

  1. 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; relfexive direct bilirubin testing will be used to confirm Gilbert's syndrome;
  2. Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the Child-Pugh classification;
  3. Active liver disease (e.g. cirrhosis, alcoholic liver disease, hepatitis B, hepatitis C, automimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of HIV or AIDS;
  4. Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;
  5. 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;
  6. 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;
  7. 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;
  8. 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);
  9. New York Heart Association Class III or IV heart failure;
  10. 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;
  11. 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;
  12. Uncontrolled hypertension, defined as sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg, and confirmed by repeat measurement;
  13. Currently receiving cancer treatments or, in the Investigator's opinion, at risk of relapse for recent cancer;
  14. 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);
  15. Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid-regulating agent;
  16. Use of any excluded medications or supplements (e.g. potent cytochrome P450 [CYP] 3A4 inhibitors as described in Appendix D;
  17. History of drug or alcohol abuse within the past year or inabilty to comply with protocol requirements, including subjects restrictions (see Section 5.6.3);
  18. 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;
  19. Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02634151

Contacts
Contact: Liz Masson lmasson@gemphire.com
Contact: Laura Lovelace llovelace@gemphire.com

Locations
United States, Alabama
Central Research Associates, Inc. Recruiting
Birmingham, Alabama, United States, 35205
Contact: Shellie Talley, RN    205-327-1077      
Principal Investigator: David DeAtkine, M.D.         
United States, California
Westside Medical Associates of Los Angeles Recruiting
Beverly Hills, California, United States, 90211
Contact: Laurn Contreras    310-289-5221      
Principal Investigator: Norman Lepor, M.D.         
National Research Institute Recruiting
Huntington Park, California, United States, 90255
Contact: Ari Cabrera    213-483-1800      
Principal Investigator: Stanley Hsia, M.D.         
National Research Institute Recruiting
Los Angeles, California, United States, 90057
Contact: Marilou Dichoso    213-483-1800      
Contact: Sergio Diaz    213-483-1800      
Principal Investigator: Juan Frias, M.D.         
United States, Florida
Atlantic Clinical Research Collaborative- Cardiology Recruiting
Atlantis, Florida, United States, 33462
Contact: Gabriele Reyes    561-966-8815      
Principal Investigator: Debra Weinstein, M.D.         
Excel Medical Clinical Trials Recruiting
Boca Raton, Florida, United States, 33434
Contact: Ashlee Mattone    561-756-8206      
Principal Investigator: Seth Baum, M.D.         
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Contact: Heather Sanzari    904-730-0166      
Principal Investigator: Alpa Patel, M.D.         
Health Awareness, Inc. Recruiting
Jupiter, Florida, United States, 33458
Contact: Doug Surowitz    561-741-2033      
Principal Investigator: Ronald Surowitz, DO         
Meridien Research, Inc. Recruiting
Maitland, Florida, United States, 32751
Contact: Ruben Moliere, RN    407-644-1165      
Principal Investigator: Eva Heurich, D.O.         
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Contact: Alexander White, M.D.    386-304-7070      
Principal Investigator: Alexander White, M.D.         
Varkey Medical Recruiting
Tampa, Florida, United States, 33626
Contact: Cory Rutkowski    727-724-9730      
Principal Investigator: Vigel Varkey, M.D.         
United States, Illinois
Evanston Premier Healthcare Research, LLC Recruiting
Evanston, Illinois, United States, 60201
Contact    847-869-1191    evanstonresearch@gmail.com   
Principal Investigator: Jeffrey Geohas, M.D.         
United States, Indiana
Midwest Institute for Clinical Research Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Phillip D. Toth, M.D.    317-705-7050      
Principal Investigator: Phillip D. Toth, M.D.         
United States, Kentucky
L-MARC Recruiting
Louisville, Kentucky, United States, 40213
Contact: Whitney Asher    502-214-3901      
Principal Investigator: Harold Bays, M.D.         
United States, New York
Mid-Hudson Medical Research Recruiting
New Windsor, New York, United States, 12553
Contact    844-337-8839    crc@mhmresearch.com   
Principal Investigator: Sashi K Makam, M.D.         
Rochester Clinical Research, Inc. Recruiting
Rochester, New York, United States, 14609
Contact: Matthew Davis, M.D.    585-288-0890      
Principal Investigator: Matthew Davis, M.D.         
United States, Ohio
Sterling Research Group, Ltd. Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Betsy Harris    513-621-5112      
Principal Investigator: Phillip Diller, M.D.         
Sentral Clinical Research Services Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Kim Kelso    513-791-1600    kkelso@sentralcrs.com   
Principal Investigator: James Pritchard, M.D.         
Sterling Research Group, Ltd. Recruiting
Cincinnati, Ohio, United States, 45246
Contact: Betsy Harris    513-621-5112      
Principal Investigator: Matthew Wenker, M.D.         
United States, Pennsylvania
Green and Seidner Family Practice Associates Recruiting
Lansdale, Pennsylvania, United States, 19446
Contact: Karen Sosonkin    215-361-7164    kmsosonkin@aol.com   
Principal Investigator: Jack Rosenfeld, M.D.         
United States, Texas
Associates in Medicine Recruiting
Houston, Texas, United States, 77027
Contact: Timberly Gilford, M.D.    281-340-8515      
Principal Investigator: Timberly Gilford, M.D.         
Diagnostics Research Grup Recruiting
San Antonio, Texas, United States, 78229
Contact: Charles Andrews, M.D.    210-692-7157      
Principal Investigator: Charles Andrews, M.D.         
Sugar Lakes Family Practice Recruiting
Sugar Land, Texas, United States, 77479
Contact: J. Mark Trippett, M.D.    281-340-8515      
Principal Investigator: J. Mark Trippett, M.D.         
United States, Virginia
National Research Institute Recruiting
Richmond, Virginia, United States
Contact: Bedelia Domagalski    804-755-2300      
Principal Investigator: Keith Scott, M.D.         
Sponsors and Collaborators
Gemphire Therapeutics, Inc.
  More Information

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02634151     History of Changes
Other Study ID Numbers: GEM-301
Study First Received: December 11, 2015
Last Updated: November 14, 2016

Keywords provided by Gemphire Therapeutics, Inc.:
LDL‐C
Lipid Regulator

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 24, 2017