Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia

Aegerion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Atorvastatin; Drug: AEGR-733

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690443

AEGR-733-006

Details and patient eligibility

About

Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.

Full description

Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/< 1 drink per day.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• M/F 18-70
• 0-1 risk factor, mean LDL-C -/> 160 and -/< 250 mg/dL (Visit 2 & 3)
• 2+ risk factors, mean LDL-C -/> 130 & -/< 250 mg/dL (Visit 2 & 3)
• Fasting mean TGs -/< 400 mg/dL
• Understanding and compliance of protocol
• sign consent

Exclusion criteria

• Females pregnant, lactating, or CBP who have not been using acceptable contraceptive methods over previous 3 months
• Uncontrolled hypertension >180/95 at screening
• Hx of chronic renal insufficiency (serum creatinine > 2.5 mg/dL)
• Hx of liver disease or transaminases > 1.5 X ULN
• Positive for Hepatitis B or C
• Major surgery within past 3 mos
• Cardiac insufficiency defined as functional Class II-Class IV
• Hx of malignancy within previous 5 years
• Participation in another investigational drug study within past 6 wks
• Serious or unstable medical or psychological condition
• Regular alcohol use > 1 drink per day
• Regular consumers of grapefruit juice or medications known to be metabolized by CYP 3A4
• Use of other lipid-lowering meds (washout permitted)
• Acute CVD
• Diabetes Mellitus
• Fasting glucose >110 mg/dL
• BMI -/> 40 kg/m2
• Significant gastrointestinal symptoms such as IBS
• Use of fish oils, niacin, herbal wt. loss products (washout permitted)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

2

Active Comparator group

Description:

2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8

Treatment:

Drug: AEGR-733

1

Active Comparator group

Description:

Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.

Treatment:

Drug: Atorvastatin