Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LMT · 1 trial · 1 indication
Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least- squares (LS) means and standard errors at Week 24 were obtained from a mixed -effect model with repeated measures (MMRM) to account for missing data. All available post -baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model.
| Arm | Type | Description |
|---|---|---|
| Alirocumab 75 mg/up to 150 mg | EXPERIMENTAL | Alirocumab 75 mg every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8. |
| Placebo | PLACEBO_COMPARATOR | Placebo matched to alirocumab SC injection for 78-week treatment duration. |
| Name | Type | Description |
|---|---|---|
| LMT (atorvastatin, simvastatin, or rosuvastatin) | DRUG | - |
| alirocumab | DRUG | Alirocumab administered as a subcutaneous (SC) injection of 1 mL into the abdomen, thigh, or outer area of the upper arm. |
| Placebo | DRUG | Placebo matched to alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm. |
Inclusion Criteria: 1. Patients with heFH\* who are not adequately controlled\*\* with a maximally-tolerated daily dose\*\*\* of statin with or without other LMT, at a stable dose prior to the screening visit (week -2). \*Diagnosis of heFH must be made either by genotyping or by clinical criter...
LMT is a small molecule being studied for the treatment of heterozygous familial hypercholesterolemia (HeFH), a genetic condition causing high cholesterol. It is intended for patients who are not adequately controlled with their current lipid-modifying therapy. LMT is currently in Phase 3 clinical development and is not yet approved.
LMT is a lipid-modifying therapy, as indicated by its full name in the clinical trial. It is being studied in patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their current lipid-modifying therapy. The specific molecular target of LMT is not disclosed in the available information.
LMT is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. Regeneron is conducting clinical trials to evaluate LMT for the treatment of heterozygous familial hypercholesterolemia.
LMT is in Phase 3 clinical development. It has completed one Phase 3 trial, and it is not yet approved by regulatory authorities. The drug is being investigated for use in patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their current lipid-modifying therapy.
LMT has one completed Phase 3 clinical trial with the identifier NCT01709500. This trial studied LMT in patients with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy. The trial enrolled 249 participants and was conducted in Czechia, Netherlands, Norway, and the United Kingdom.