Recent Updates
Recently added Catalysts

LLG783

Phase 2

Peripheral Artery Disease (PAD); Intermittent Claudication | Small molecule | Cardiovascular |Novartis AG|Last Updated: Jan 5, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03194776Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent ClaudicationPHASE2 COMPLETED 46 — — Sep 20, 2017Dec 27, 2018Jan 5, 20218 United States, Germany +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
Up to 32 Weeks

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.

Change From Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16
Baseline, Week 16 (Day 113)

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.

Secondary Endpoints
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)
1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point 't' (AUC[0-t])
1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LLG783EXPERIMENTALPatients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks.
PlaceboPLACEBO_COMPARATORPatients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks.
Interventions
NameTypeDescription
LLG783DRUGLLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.
PlaceboDRUGPlacebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.
Unlock Study Design Details
Eligibility Criteria
Age Range40 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites8

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...

Countries:United StatesGermanyTaiwan
Unlock Eligibility Criteria