Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LLG783 · 1 trial · 1 indication
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a participant after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hospitalization or prolongation of existing hospitalization and is is medically significant.
MWD was assessed by the 6MWT prior to dosing was used to evaluate functional capacity of peripheral artery disease (PAD) participants. 6MWT test included measurement of total distance walked in 6 minutes.
| Arm | Type | Description |
|---|---|---|
| LLG783 | EXPERIMENTAL | Patients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Patients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| LLG783 | DRUG | LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration. |
| Placebo | DRUG | Placebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration. |
Inclusion Criteria: * claudication, as defined by pain with exertion in either leg; * On stable medical therapy, including statins, aspirin, and antihypertensive medications (as medically indicated) unless individually contraindicated, for at least 4 weeks prior to the screening visit; * Vital sign...
LLG783 is an investigational small molecule being studied for the treatment of Peripheral Artery Disease (PAD) and Intermittent Claudication. It is a cardiovascular therapeutic developed by Novartis AG. The drug is currently in Phase 2 clinical development, meaning it is not yet approved and remains under investigation for safety and efficacy.
The specific molecular target of LLG783 has not been disclosed in available information. The drug is a small molecule being investigated for its potential effects in Peripheral Artery Disease and Intermittent Claudication, but its mechanism of action is not publicly detailed.
LLG783 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical research on this investigational drug for cardiovascular indications.
LLG783 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not received FDA approval, as it is still undergoing clinical evaluation.
LLG783 has one completed clinical trial registered as NCT03194776, titled 'Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication.' This Phase 2 study enrolled 46 participants across the United States, Germany, and Taiwan, and was placebo-controlled.
No alternative names for LLG783 have been disclosed. The drug is identified solely by its code name LLG783 in clinical trial registrations and available information. It is a distinct investigational compound developed by Novartis.