The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

Phase 2

Completed

• Conditions: Insulin Sensitivity
• Interventions: Drug: Gemcabene 900 mg; Drug: Placebo

• Registration Number: NCT02586168
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2001-10
• Study Completion: 2001-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-26
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcabene 900 mg	Gemcabene 900 mg	Gemcabene 900 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	4 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical Laboratory - hematology, chemistry	4 weeks	Clinical Laboratory Abnormalities
Adverse Events	4 weeks
ECG	4 weeks	Clinically Significant Changes