Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
NCT ID: NCT01859455
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2011-07-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Patient: LGT209 50 mg
50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients
LGT209 50 mg
Active experimental drug
Statins (atorvastatin or simvastatin)
Stable doses of atorvastatin or simvastatin
Patient: LGT209 300 mg
300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients
LGT209 300 mg
Active experimental drug
Statins (atorvastatin or simvastatin)
Stable doses of atorvastatin or simvastatin
Healthy Volunteers: LGT209 300 mg
300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers
LGT209 300 mg
Active experimental drug
Patient: Placebo
matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients
Placebo
Placebo comparator
Statins (atorvastatin or simvastatin)
Stable doses of atorvastatin or simvastatin
Healthy volunteers: Placebo
matching placebo subcutaneous (SC) of LGT209 300 mg in healthy volunteers
Placebo
Placebo comparator
Interventions
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LGT209 50 mg
Active experimental drug
LGT209 300 mg
Active experimental drug
Placebo
Placebo comparator
Statins (atorvastatin or simvastatin)
Stable doses of atorvastatin or simvastatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Fort Myers, Florida, United States
Novartis Investigative Site
Miramar, Florida, United States
Countries
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Related Links
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Results for CLGT209X2105 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLGT209X2105
Identifier Type: -
Identifier Source: org_study_id