The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

April 8, 2020 updated by: NeuroBo Pharmaceuticals Inc.

The Effect of Gemcabene (CI-1027) on Insulin Sensitivity in Nondiabetic Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin sensitivity
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 4 weeks
4 weeks
ECG
Time Frame: 4 weeks
Clinically Significant Changes
4 weeks
Clinical Laboratory - hematology, chemistry
Time Frame: 4 weeks
Clinical Laboratory Abnormalities
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroBo Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

October 1, 2001

Study Completion (Actual)

October 1, 2001

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1027-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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