NCT01859455

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

A Randomized, Double-blind, Placebo-controlled, Single Dose, Parallel Group Study to Assess the Safety, Tolerability, Bioavailability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous LGT209 in Hypercholesterolemic Patients on Stable Doses of Atorvastatin or Simvastatin and in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hypercholesterolemia
• LDL Cholesterol

Interventions

Type	Name	Description
DRUG	LGT209 50 mg	Active experimental drug
DRUG	LGT209 300 mg	Active experimental drug
DRUG	Placebo	Placebo comparator
DRUG	Statins (atorvastatin or simvastatin)	Stable doses of atorvastatin or simvastatin

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2013-05-22
• Last updated: 2020-12-17

Locations

2 sites across 1 country: United States