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The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

Primary Purpose

Insulin Sensitivity

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

About this trial

This is an interventional basic science trial for Insulin Sensitivity focused on measuring Insulin Resistance, Lipid Regulator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments
  • Males; and females of non-reproductive potential
  • Obesity
  • Non-diabetic

Exclusion Criteria:

  • Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day 1. Hormone Replacement Therapy is acceptable.
  • Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening
  • Use of any anti-diabetic medications
  • Use of any steroid medications
  • Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1
  • If female, pregnant, lactating or of childbearing potential; and
  • History of significant reaction to any fibrate lipid-lowering agent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Gemcabene 900 mg

    Placebo

    Arm Description

    Gemcabene 900 mg

    Placebo

    Outcomes

    Primary Outcome Measures

    Insulin sensitivity

    Secondary Outcome Measures

    Adverse Events
    ECG
    Clinically Significant Changes
    Clinical Laboratory - hematology, chemistry
    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
    NCT02586168
    Brief Title
    The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects
    Official Title
    The Effect of Gemcabene (CI-1027) on Insulin Sensitivity in Nondiabetic Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2001 (undefined)
    Primary Completion Date
    October 2001 (Actual)
    Study Completion Date
    October 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 determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Sensitivity
    Keywords
    Insulin Resistance, Lipid Regulator

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gemcabene 900 mg
    Arm Type
    Experimental
    Arm Description
    Gemcabene 900 mg
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcabene 900 mg
    Intervention Description
    Gemcabene 900 mg once daily (QD)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Insulin sensitivity
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Adverse Events
    Time Frame
    4 weeks
    Title
    ECG
    Description
    Clinically Significant Changes
    Time Frame
    4 weeks
    Title
    Clinical Laboratory - hematology, chemistry
    Description
    Clinical Laboratory Abnormalities
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments Males; and females of non-reproductive potential Obesity Non-diabetic Exclusion Criteria: Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day 1. Hormone Replacement Therapy is acceptable. Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening Use of any anti-diabetic medications Use of any steroid medications Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1 If female, pregnant, lactating or of childbearing potential; and History of significant reaction to any fibrate lipid-lowering agent

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

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