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The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

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ClinicalTrials.gov Identifier: NCT02586168
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.

Brief Summary:
The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Drug: Gemcabene 900 mg Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
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
Study Start Date : July 2001
Actual Primary Completion Date : October 2001
Actual Study Completion Date : October 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gemcabene 900 mg
Gemcabene 900 mg
Drug: Gemcabene 900 mg
Gemcabene 900 mg once daily (QD)
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo



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

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

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



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

Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02586168     History of Changes
Other Study ID Numbers: 1027-014
First Posted: October 26, 2015    Key Record Dates
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