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The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

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. Identifier: NCT02586168
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : April 9, 2020
Information provided by (Responsible Party):
NeuroBo Pharmaceuticals 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

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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
Drug Information available for: Insulin

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

Placebo Comparator: Placebo
Drug: 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Responsible Party: NeuroBo Pharmaceuticals Inc. Identifier: NCT02586168    
Other Study ID Numbers: 1027-014
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Keywords provided by NeuroBo Pharmaceuticals Inc.:
Insulin Resistance
Lipid Regulator
Additional relevant MeSH terms:
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Insulin Resistance
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases