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OpenTrials
Completed

NCT Number: NCT02586168

The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcabene 900 mg

Drug

Gemcabene 900 mg once daily (QD)

Placebo

Drug

Placebo

Primary outcomes

  1. Insulin sensitivity

    Time frame: 4 weeks

Secondary outcomes

  1. Adverse Events

    Time frame: 4 weeks

  2. ECG

    Time frame: 4 weeks

    Clinically Significant Changes

  3. Clinical Laboratory - hematology, chemistry

    Time frame: 4 weeks

    Clinical Laboratory Abnormalities

Sponsors and collaborators

Lead sponsor

NeuroBo Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Oct 26, 2015
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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