Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins

Novartis

Status and phase: Completed; Phase 1

Conditions: LDL Cholesterol; Hypercholesterolemia

Treatments: Drug: LGT209 50 mg; Drug: Statins (atorvastatin or simvastatin); Drug: LGT209 300 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859455

CLGT209X2105

Details and patient eligibility

About

This study is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications and in healthy volunteers.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers: Male and female subjects 18 to 70 years of age, in general good health with fasting LDL-cholesterol >90 mg/dL and fasting serum triglycerides <400 mg/dL
• Patients on statin therapy: Male and female patients 18 to 70 years of age receiving atorvastatin or simvastatin and with fasting LDL-cholesterol >90 mg/dL and fasting serum triglycerides <400 mg/dL

Exclusion criteria

Healthy volunteers:

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
• Women of child-bearing potential unless using highly effective methods of contraception
• Conditions which might impact the safety or biologic activity of the study drug

Statin patients:

• Use of concomitant medications known to impact the safe use or efficacy of atorvastatin and simvastatin based on drug labels
• Women of childbearing potential unless using highly effective methods of contraception during dosing and for at least 100 days after study drug administration
• Conditions which might impact the safety or biologic activity of the study drug

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 5 patient groups, including a placebo group

Patient: LGT209 50 mg

Experimental group

Description:

50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients

Treatment:

Drug: LGT209 50 mg

Drug: Statins (atorvastatin or simvastatin)

Patient: LGT209 300 mg

Experimental group

Description:

300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients

Treatment:

Drug: LGT209 300 mg

Drug: Statins (atorvastatin or simvastatin)

Healthy Volunteers: LGT209 300 mg

Experimental group

Description:

300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers

Treatment:

Drug: LGT209 300 mg

Patient: Placebo

Placebo Comparator group

Description:

matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients

Treatment:

Drug: Placebo

Drug: Statins (atorvastatin or simvastatin)

Healthy volunteers: Placebo

Placebo Comparator group

Description:

matching placebo subcutaneous (SC) of LGT209 300 mg in healthy volunteers

Treatment:

Drug: Placebo