The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

NeuroBo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Insulin Sensitivity

Treatments: Drug: Gemcabene 900 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02586168

1027-014

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

53 participants in 2 patient groups, including a placebo group

Gemcabene 900 mg

Experimental group

Description:

Gemcabene 900 mg

Treatment:

Drug: Gemcabene 900 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo