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

• Status: Completed
• Trial end date: 2001-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemphire Therapeutics, Inc.; NeuroBo Pharmaceuticals Inc.

Criteria

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