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...
Top 12 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 4 | PHASE3 | Enlicitide |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Inclisiran, Pelacarsen, DII235, QCZ484 |
| AstraZeneca PLC | AZN | 3 | PHASE3 | AZD0780, Laroprovstat, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 5 | PHASE3 | Plozasiran, zodasiran, VSA003 |
| Ionis Pharmaceuticals, Inc. | IONS | 2 | PHASE3 | Olezarsen, ION775 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE2 | Alirocumab |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Solbinsiran |
| MediciNova, Inc. | MNOV | 1 | PHASE2 | MN-001 |
| Verve Therapeutics, Inc. | VERV | 4 | PHASE2 | VERVE-102, VERVE-201 |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE1 | Obicetrapib |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| Esperion Therapeutics, Inc. | ESPR | 1 | - | Bempedoic acid+ Ezetimibe |
LGT209 is an investigational small molecule developed by Novartis AG for hypercholesterolemia, a condition of elevated cholesterol. It was studied in Phase 1 clinical trials in healthy volunteers and in patients with hypercholesterolemia, including patients already treated with statins. It is not an approved therapy.
LGT209 was developed for hypercholesterolemia, including elevated LDL cholesterol. Clinical testing enrolled healthy volunteers with elevated cholesterol and hypercholesterolemic patients receiving statin treatment. The trials examined safety, tolerability, pharmacokinetics and pharmacodynamics rather than confirming a treatment benefit.
LGT209 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored both Phase 1 trials of the compound, conducted in the United States.
LGT209 is in Phase 1 development. Two Phase 1 trials have been completed, and no trials are currently active. The studies together enrolled 99 participants and evaluated safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and hypercholesterolemic patients.
LGT209 has been studied in two completed Phase 1 trials: NCT01979601, which assessed safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and patients with hypercholesterolemia, and NCT01859455, which studied healthy volunteers with elevated cholesterol and hypercholesterolemic patients treated with statins. Both were randomized, double-blind and placebo-controlled.