Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia

Completed · Phase 1 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

This study is designed to measure the effects of LGT209 when given intravenously to patients with high cholesterol who are on stable doses of statin medications, and to healthy subjects with elevated cholesterol

Key facts

Study ID

NCT01979601

Run by

Novartis Pharmaceuticals

People needed

74

Starts

2010-12-01

Expected to finish

2011-11-01

Last updated by the study team

2013-12-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy volunteers: Male and female subjects 18 to 70 years of age, in general good health but with high cholesterol
• Statin patients: Male and female patients 18 to 70 years of age, with high cholesterol on stable statin therapy for at least 3 months

You may not qualify if…

• 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
• Statin patients: Use of any prescription drugs for lipid lowering other than HMG CO-A reductase inhibitors (statins); use of two concurrent antihypertensive medications is allowed, provided stable dosing has been achieved for the prior 3 months
• Women of child-bearing potential unless using highly effective methods of contraception
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Miami Gardens, Florida, United States
• Novartis Investigative Site — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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