Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

April 8, 2020 updated by: NeuroBo Pharmaceuticals Inc.

An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin

The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and Females
  • 18 to 65 years of age
  • Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)

Exclusion Criteria:

  • If female, postmenopausal or surgically menopausal
  • Triglycerides (TG) >400 mg/dL
  • Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
  • Body Mass Index (BMI) >35 kg/m2
  • Uncontrolled diabetes mellitus (HbA1c >10%)
  • Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN)
  • Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)
  • Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo treatment on stable background statin therapy
Drug: Placebo
Experimental: Gemcabene 300 mg QD
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Drug: Gemcabene
1-300 mg tablet, QD, 56 days
Drug: Gemcabene
3-300 mg tablets, QD, 56 days
Experimental: Gemcabene 900 mg QD
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Drug: Gemcabene
1-300 mg tablet, QD, 56 days
Drug: Gemcabene
3-300 mg tablets, QD, 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL-C - percent change from baseline at Week 8
Time Frame: 56 days
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 56 days
56 days
Plasma lipid levels - percent change from baseline at Week 8
Time Frame: 56 days
apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)
56 days
Clinical Laboratory
Time Frame: 56 days
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroBo Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

April 1, 2002

Study Completion (Actual)

April 1, 2002

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1027-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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