The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

Insulin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586168
• Other study ID #: 1027-014
• Status: Completed
• Phase: Phase 2
• Start date: July 2001
• Est. completion date: October 2001

Study information

• Verified date: April 2020
• Source: NeuroBo Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2001
• Est. primary completion date: October 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity

Intervention

Drug:
• Gemcabene 900 mg
Gemcabene 900 mg once daily (QD)
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NeuroBo Pharmaceuticals Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		4 weeks
Secondary	Adverse Events		4 weeks
Secondary	ECG	Clinically Significant Changes	4 weeks
Secondary	Clinical Laboratory - hematology, chemistry	Clinical Laboratory Abnormalities	4 weeks