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Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

Primary Purpose

Hypercholesterolemia, Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gemcabene 150 mg
Gemcabene 300 mg
Gemcabene 600 mg
Gemcabene 900 mg
Placebo
Sponsored by
NeuroBo Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Lipid Regulator, TG

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or naturally postmenopausal or surgically menopausal women
  • 18 to 80 years of age
  • Baseline HDL-C <35 mg/dL (0.9 mmol/L)

Exclusion Criteria:

  • Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
  • Body Mass Index (BMI) >35 kg/m2
  • Uncontrolled Hypertension >95 mm Hg
  • Uncontrolled diabetes mellitus (HbA1c >10%)
  • Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN);
  • Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)
  • Uncontrolled hypothyroidism (TSH >1.5 × ULN)
  • Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Gemcabene 150 mg

    Gemcabene 300 mg

    Gemcabene 600 mg

    Gemcabene 900 mg

    Placebo

    Arm Description

    Gemcabene 150 mg once daily (QD)

    Gemcabene 300 mg once daily (QD)

    Gemcabene 600 mg once daily (QD)

    Gemcabene 900 mg once daily (QD)

    Placebo once daily (QD)

    Outcomes

    Primary Outcome Measures

    HDL-C - percent change from baseline

    Secondary Outcome Measures

    Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline
    Adverse Events
    Clinical Laboratory - hematology, chemistry, urinalysis
    Clinical Laboratory Abnormalities

    Full Information

    First Posted
    October 22, 2015
    Last Updated
    April 8, 2020
    Sponsor
    NeuroBo Pharmaceuticals Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02585869
    Brief Title
    Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
    Official Title
    A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1999 (undefined)
    Primary Completion Date
    June 2001 (Actual)
    Study Completion Date
    June 2001 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NeuroBo Pharmaceuticals Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Hypertriglyceridemia
    Keywords
    Lipid Regulator, TG

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    161 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gemcabene 150 mg
    Arm Type
    Experimental
    Arm Description
    Gemcabene 150 mg once daily (QD)
    Arm Title
    Gemcabene 300 mg
    Arm Type
    Experimental
    Arm Description
    Gemcabene 300 mg once daily (QD)
    Arm Title
    Gemcabene 600 mg
    Arm Type
    Experimental
    Arm Description
    Gemcabene 600 mg once daily (QD)
    Arm Title
    Gemcabene 900 mg
    Arm Type
    Experimental
    Arm Description
    Gemcabene 900 mg once daily (QD)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo once daily (QD)
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcabene 150 mg
    Intervention Description
    Blinded capsules and tablets, 150 mg, once daily, 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcabene 300 mg
    Intervention Description
    Blinded capsules and tablets, 300 mg, once daily, 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcabene 600 mg
    Intervention Description
    Blinded capsules and tablets, 600 mg, once daily, 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcabene 900 mg
    Intervention Description
    Blinded capsules and tablets, 900 mg, once daily, 84 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Blinded capsule and tablets, once daily, 84 days
    Primary Outcome Measure Information:
    Title
    HDL-C - percent change from baseline
    Time Frame
    84 days
    Secondary Outcome Measure Information:
    Title
    Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline
    Time Frame
    84 days
    Title
    Adverse Events
    Time Frame
    84 days
    Title
    Clinical Laboratory - hematology, chemistry, urinalysis
    Description
    Clinical Laboratory Abnormalities
    Time Frame
    84 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men or naturally postmenopausal or surgically menopausal women 18 to 80 years of age Baseline HDL-C <35 mg/dL (0.9 mmol/L) Exclusion Criteria: Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN) Body Mass Index (BMI) >35 kg/m2 Uncontrolled Hypertension >95 mm Hg Uncontrolled diabetes mellitus (HbA1c >10%) Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN); Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN) Uncontrolled hypothyroidism (TSH >1.5 × ULN) Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous 3 months

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12943873
    Citation
    Bays HE, McKenney JM, Dujovne CA, Schrott HG, Zema MJ, Nyberg J, MacDougall DE; Gemcabene Study Group. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol. Am J Cardiol. 2003 Sep 1;92(5):538-43. doi: 10.1016/s0002-9149(03)00721-5.
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    Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

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