NCT02586168

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

October 22, 2015

Last Update Submit

April 8, 2020

Conditions

Insulin Sensitivity

Keywords

Insulin ResistanceLipid Regulator

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    4 weeks

Secondary Outcomes (3)

  • Adverse Events

    4 weeks

  • ECG

    4 weeks

  • Clinical Laboratory - hematology, chemistry

    4 weeks

Study Arms (2)

Gemcabene 900 mg

EXPERIMENTAL

Gemcabene 900 mg

Drug: Gemcabene 900 mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Gemcabene 900 mgDRUG

Gemcabene 900 mg once daily (QD)

Gemcabene 900 mg
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments
  • Males; and females of non-reproductive potential
  • Obesity
  • Non-diabetic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin Resistance

Interventions

gemcabene

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 26, 2015

Study Start

July 1, 2001

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

April 9, 2020

Record last verified: 2020-04