Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01859455 | Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins | PHASE1 | COMPLETED | 25 | — | — | Jul 1, 2011 | Jul 1, 2012 | Dec 17, 2020 | 2 | United States |
| NCT01979601 | Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia | PHASE1 | COMPLETED | 74 | — | — | Dec 1, 2010 | Nov 1, 2011 | Dec 10, 2013 | 2 | United States |
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1)
Baseline was defined as the arithmetic mean of all the pre-treatment values (i.e. Screening, Day -1 and predose on Day 1)
| Arm | Type | Description |
|---|---|---|
| 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 |
| Patient: LGT209 0.3 mg/kg | EXPERIMENTAL | 0.3 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
| Patient: LGT209 1 mg/kg | EXPERIMENTAL | 1 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
| Patient: LGT209 3 mg/kg | EXPERIMENTAL | 3 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
| Patient: LGT209 10 mg/kg | EXPERIMENTAL | 10 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
| Patient: LGT209 20 mg/kg | EXPERIMENTAL | 20 mg/kg LGT209 intravenous administration in patients on stable doses of statins |
| Healthy Volunteers: LGT209 0.3 mg/kg | EXPERIMENTAL | 0.3 mg/kg LGT209 intravenous administration in healthy volunteers |
| Healthy Volunteers: LGT209 1 mg/kg | EXPERIMENTAL | 1 mg/kg LGT209 intravenous administration in healthy volunteers |
| Healthy Volunteers: LGT209 3 mg/kg | EXPERIMENTAL | 3 mg/kg LGT209 intravenous administration in healthy volunteers |
| Healthy Volunteers: LGT209 10 mg/kg | EXPERIMENTAL | 10 mg/kg LGT209 intravenous administration in healthy volunteers |
| Healthy Volunteers: 20 mg/kg | EXPERIMENTAL | 20 mg/kg LGT209 intravenous administration in healthy volunteers |
| Name | Type | Description |
|---|---|---|
| LGT209 50 mg | DRUG | Active experimental drug |
| LGT209 300 mg | DRUG | Active experimental drug |
| Placebo | DRUG | Placebo comparator |
| Statins (atorvastatin or simvastatin) | DRUG | Stable doses of atorvastatin or simvastatin |
| LGT209 | DRUG | 150 mg lyophilized powder in glass vial |
Inclusion Criteria: * Healthy volunteers: Male and female subjects 18 to 70 years of age, in general good health with fasting LDL-cholesterol \>90 mg/dL and fasting serum triglycerides \<400 mg/dL * Patients on statin therapy: Male and female patients 18 to 70 years of age receiving atorvastatin or...