Insulin Sensitivity
Conditions
Keywords
Insulin Resistance, Lipid Regulator
Brief summary
The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.
Interventions
DRUGGemcabene 900 mg
Gemcabene 900 mg once daily (QD)
DRUGPlacebo
Placebo
Sponsors
NeuroBo Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin sensitivity | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 4 weeks | — |
| ECG | 4 weeks | Clinically Significant Changes |
| Clinical Laboratory - hematology, chemistry | 4 weeks | Clinical Laboratory Abnormalities |
Outcome results
None listed