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

NeuroBo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypertriglyceridemia; Hypercholesterolemia

Treatments: Drug: Gemcabene 900 mg; Drug: Placebo; Drug: Gemcabene 150 mg; Drug: Gemcabene 600 mg; Drug: Gemcabene 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02585869

1027-004

Details and patient eligibility

About

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

Enrollment: 161 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 5 patient groups, including a placebo group

Gemcabene 150 mg

Experimental group

Description:

Gemcabene 150 mg once daily (QD)

Treatment:

Drug: Gemcabene 150 mg

Gemcabene 300 mg

Experimental group

Description:

Gemcabene 300 mg once daily (QD)

Treatment:

Drug: Gemcabene 300 mg

Gemcabene 600 mg

Experimental group

Description:

Gemcabene 600 mg once daily (QD)

Treatment:

Drug: Gemcabene 600 mg

Gemcabene 900 mg

Experimental group

Description:

Gemcabene 900 mg once daily (QD)

Treatment:

Drug: Gemcabene 900 mg

Placebo

Placebo Comparator group

Description:

Placebo once daily (QD)

Treatment:

Drug: Placebo