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The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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