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

Novartis

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: LGT209; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01979601

CLGT209X2101

Details and patient eligibility

About

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

Enrollment: 74 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 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

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 12 patient groups, including a placebo group

Patient: LGT209 0.3 mg/kg

Experimental group

Description:

0.3 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Treatment:

Drug: LGT209

Patient: LGT209 1 mg/kg

Experimental group

Description:

1 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Treatment:

Drug: LGT209

Patient: LGT209 3 mg/kg

Experimental group

Description:

3 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Treatment:

Drug: LGT209

Patient: LGT209 10 mg/kg

Experimental group

Description:

10 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Treatment:

Drug: LGT209

Patient: LGT209 20 mg/kg

Experimental group

Description:

20 mg/kg LGT209 intravenous administration in patients on stable doses of statins

Treatment:

Drug: LGT209

Healthy Volunteers: LGT209 0.3 mg/kg

Experimental group

Description:

0.3 mg/kg LGT209 intravenous administration in healthy volunteers

Treatment:

Drug: LGT209

Healthy Volunteers: LGT209 1 mg/kg

Experimental group

Description:

1 mg/kg LGT209 intravenous administration in healthy volunteers

Treatment:

Drug: LGT209

Healthy Volunteers: LGT209 3 mg/kg

Experimental group

Description:

3 mg/kg LGT209 intravenous administration in healthy volunteers

Treatment:

Drug: LGT209

Healthy Volunteers: LGT209 10 mg/kg

Experimental group

Description:

10 mg/kg LGT209 intravenous administration in healthy volunteers

Treatment:

Drug: LGT209

Healthy Volunteers: 20 mg/kg

Experimental group

Description:

20 mg/kg LGT209 intravenous administration in healthy volunteers

Treatment:

Drug: LGT209

Patient: Placebo

Placebo Comparator group

Description:

Matching intravenous placebo in patients on stable doses of statins

Treatment:

Drug: Placebo

Healthy Volunteers: Placebo

Placebo Comparator group

Description:

Matching intravenous placebo in healthy volunteers

Treatment:

Drug: Placebo