Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient: LGT209 50 mg | Experimental | 50 mg LGT209 subcutaneous (SC) (1 mL injection x 1 site) in statin patients |
|
| Patient: LGT209 300 mg | Experimental | 300 mg LGT209 subcutaneous (SC) (1 mL injection x 2 sites) in statin patients |
|
| Healthy Volunteers: LGT209 300 mg | Experimental | 300 mg LGT209 or placebo subcutaneous (SC) (1 mL injection x 2 sites) in healthy volunteers |
|
| Patient: Placebo | Placebo Comparator | matching placebo subcutaneous (SC) of LGT209 50 mg or 300 mg in statin patients |
|
| Healthy volunteers: Placebo | Placebo Comparator | matching placebo subcutaneous (SC) of LGT209 300 mg in healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGT209 50 mg | Drug | Active experimental drug |
| |
| LGT209 300 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects (patients and healthy volunteers) with adverse events, serious adverse events and death | 12 weeks | |
| Plasma concentrations of LGT209 following subcutaneous administration | 12 weeks | |
| Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) concentration | baseline and 12 weeks | |
| Change from baseline in low density lipoprotein-cholesterol (LDL-C) concentration | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of atorvastatin in patients | 2 weeks | |
| Plasma concentrations of simvastatin in patients | 2 weeks | |
| Serum concentrations of PCSK9 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Healthy volunteers:
Statin patients:
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Fort Myers | Florida | 33901-8144 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| Results for CLGT209X2105 can be found on the Novartis Clinical Trial Results Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Active experimental drug |
|
| Placebo | Drug | Placebo comparator |
|
| Statins (atorvastatin or simvastatin) | Drug | Stable doses of atorvastatin or simvastatin |
|
|
| 12 weeks |
| Miramar |
| Florida |
| 33025 |
| United States |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| C566337 | Hypercholesterolemia, Autosomal Dominant, 3 |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D000069059 | Atorvastatin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided