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Trial record 1 of 1 for:    NCT02586168
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The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02586168
First Posted: October 26, 2015
Last Update Posted: October 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.
  Purpose
The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.

Condition Intervention Phase
Insulin Sensitivity Drug: Gemcabene 900 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Gemcabene (CI‐1027) on Insulin Sensitivity in Nondiabetic Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 4 weeks ]
  • ECG [ Time Frame: 4 weeks ]
    Clinically Significant Changes

  • Clinical Laboratory - hematology, chemistry [ Time Frame: 4 weeks ]
    Clinical Laboratory Abnormalities


Enrollment: 53
Study Start Date: July 2001
Study Completion Date: October 2001
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcabene 900 mg
Gemcabene 900 mg
Drug: Gemcabene 900 mg
Gemcabene 900 mg once daily (QD)
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02586168     History of Changes
Other Study ID Numbers: 1027-014
First Submitted: October 22, 2015
First Posted: October 26, 2015
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Gemphire Therapeutics, Inc.:
Insulin Resistance
Lipid Regulator

Additional relevant MeSH terms:
Hypersensitivity
Insulin Resistance
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs