Recent Updates
Recently added Catalysts

VIA-3196

Phase 1

Drug Safety | Small molecule | Other |Madrigal Pharmaceuticals, Inc.|Last Updated: Aug 22, 2023

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 Trials2
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01519531Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy SubjectsPHASE1 COMPLETED 48Jan 1, 2012Nov 1, 2012Dec 6, 20121 United States
NCT01367873Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy SubjectsPHASE1 COMPLETED 72Jun 1, 2011Oct 1, 2011Aug 22, 20231 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Adverse Events as a measure of safety and tolerability of VIA-3196
up to 22 days

Evaluation will start from predose (Day -1) until the follow-up visit (Day 21)

Secondary Endpoints
Plasma concentration of VIA-3196
0 to 24 hours on Day 1 and Day 14
Lipid level changes following administration of VIA-3196
Day 1 to 14
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VIA-3196EXPERIMENTAL -
PlaceboPLACEBO_COMPARATORMultiple, ascending dosing groups (cohorts) will be evaluated.
Interventions
NameTypeDescription
PlaceboDRUGOral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm
VIA-3196DRUGOral, daily dosing for 14 days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The subject must be willing and able to provide written informed consent. * Healthy, non-smoking, males and females between the ages of 18 and 55 years of age (inclusive). * If female, the subject is of non-child bearing potential (i.e., surgically \[bilateral oophorectomy, hy...

Countries:United States
Unlock Eligibility Criteria