Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

April 8, 2020 updated by: NeuroBo Pharmaceuticals Inc.

A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or naturally postmenopausal or surgically menopausal women
  • 18 to 80 years of age
  • Baseline HDL-C <35 mg/dL (0.9 mmol/L)

Exclusion Criteria:

  • Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
  • Body Mass Index (BMI) >35 kg/m2
  • Uncontrolled Hypertension >95 mm Hg
  • 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)
  • Uncontrolled hypothyroidism (TSH >1.5 × 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 3 months

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
Experimental: Gemcabene 150 mg
Gemcabene 150 mg once daily (QD)
Drug: Gemcabene 150 mg
Blinded capsules and tablets, 150 mg, once daily, 84 days
Experimental: Gemcabene 300 mg
Gemcabene 300 mg once daily (QD)
Drug: Gemcabene 300 mg
Blinded capsules and tablets, 300 mg, once daily, 84 days
Experimental: Gemcabene 600 mg
Gemcabene 600 mg once daily (QD)
Drug: Gemcabene 600 mg
Blinded capsules and tablets, 600 mg, once daily, 84 days
Experimental: Gemcabene 900 mg
Gemcabene 900 mg once daily (QD)
Drug: Gemcabene 900 mg
Blinded capsules and tablets, 900 mg, once daily, 84 days
Placebo Comparator: Placebo
Placebo once daily (QD)
Drug: Placebo
Blinded capsule and tablets, once daily, 84 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HDL-C - percent change from baseline
Time Frame: 84 days
84 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline
Time Frame: 84 days
84 days
Adverse Events
Time Frame: 84 days
84 days
Clinical Laboratory - hematology, chemistry, urinalysis
Time Frame: 84 days
Clinical Laboratory Abnormalities
84 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

December 1, 1999

Primary Completion (Actual)

June 1, 2001

Study Completion (Actual)

June 1, 2001

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 23, 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

  • 1027-004

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.

Clinical Trials on Hypercholesterolemia

Clinical Trials on Gemcabene 150 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe