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

Phase 2

Completed

• Conditions: Hypercholesterolemia; Hypertriglyceridemia
• Interventions: Drug: Gemcabene 900 mg; Drug: Gemcabene 150 mg; Drug: Gemcabene 300 mg; Drug: Gemcabene 600 mg; Drug: Placebo

• Registration Number: NCT02585869
• Lead Sponsor: NeuroBo Pharmaceuticals Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2001-06
• Study Completion: 2001-06
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcabene 900 mg	Gemcabene 900 mg	Gemcabene 900 mg once daily (QD)
Gemcabene 150 mg	Gemcabene 150 mg	Gemcabene 150 mg once daily (QD)
Gemcabene 300 mg	Gemcabene 300 mg	Gemcabene 300 mg once daily (QD)
Gemcabene 600 mg	Gemcabene 600 mg	Gemcabene 600 mg once daily (QD)
Placebo	Placebo	Placebo once daily (QD)

Primary Outcome Measures

Name	Time	Method
HDL-C - percent change from baseline	84 days

Secondary Outcome Measures

Name	Time	Method
Adverse Events	84 days
Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline	84 days
Clinical Laboratory - hematology, chemistry, urinalysis	84 days	Clinical Laboratory Abnormalities