Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LGT209 · 2 trials · 2 indications
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...
LGT209 is an investigational small molecule being developed for hypercholesterolemia, a condition of elevated cholesterol levels. It is being studied in patients with hypercholesterolemia and in healthy volunteers with elevated cholesterol. The drug is currently in Phase 1 clinical development and is not yet approved.
LGT209 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The company is conducting clinical trials to evaluate the safety, pharmacokinetics, and pharmacodynamics of LGT209 in patients with hypercholesterolemia.
LGT209 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 99 participants enrolled. The drug is investigational and has not been approved by regulatory authorities. It is being studied for its safety, tolerability, and effects on cholesterol levels.
LGT209 has been studied in two completed Phase 1 trials. NCT01859455 enrolled 25 participants to evaluate safety, pharmacokinetics, and pharmacodynamics in healthy volunteers with elevated cholesterol and hypercholesterolemic patients on statins. NCT01979601 enrolled 74 participants to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and hypercholesterolemic patients.
LGT209 is the only name provided for this investigational drug. No alternative names have been reported. It is a small molecule being developed by Novartis for hypercholesterolemia, and it is currently in Phase 1 clinical trials.