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OpenTrials
Completed

NCT Number: NCT02585869

Efficacy and Safety of Gemcabene 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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Gemcabene 150 mg

Drug

Blinded capsules and tablets, 150 mg, once daily, 84 days

Gemcabene 300 mg

Drug

Blinded capsules and tablets, 300 mg, once daily, 84 days

Gemcabene 600 mg

Drug

Blinded capsules and tablets, 600 mg, once daily, 84 days

Gemcabene 900 mg

Drug

Blinded capsules and tablets, 900 mg, once daily, 84 days

Placebo

Drug

Blinded capsule and tablets, once daily, 84 days

Primary outcomes

  1. HDL-C - percent change from baseline

    Time frame: 84 days

Secondary outcomes

  1. Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline

    Time frame: 84 days

  2. Adverse Events

    Time frame: 84 days

  3. Clinical Laboratory - hematology, chemistry, urinalysis

    Time frame: 84 days

    Clinical Laboratory Abnormalities

Sponsors and collaborators

Lead sponsor

NeuroBo Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2001
Study completion
2001
First posted
Oct 23, 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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