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VIA-3196

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

VIA-3196 · 2 trials · 1 indication

Phase 1 2
NCT01519531Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy SubjectsDrug Safety
COMPLETED48 Analytics
NCT01367873Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy SubjectsDrug Safety
COMPLETED72 Analytics
PHASE1COMPLETED
Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy Subjects
Drug SafetyUnlock trial analytics
PHASE1COMPLETED
Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects
Drug SafetyUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about VIA-3196

What is VIA-3196 used for?

VIA-3196 is an investigational small molecule being studied for drug safety in healthy volunteers. It is currently in Phase 1 clinical development, with completed trials evaluating its safety profile. The drug is not approved and remains under investigation.

Who makes VIA-3196?

VIA-3196 is being developed by Madrigal Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker MDGL. The company is conducting Phase 1 clinical trials to evaluate the drug's safety in healthy subjects.

What phase is VIA-3196 in?

VIA-3196 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both focusing on drug safety in healthy volunteers. The drug is investigational and has not been approved for any use.

What clinical trials is VIA-3196 in?

VIA-3196 has been evaluated in two completed Phase 1 trials. NCT01367873 was an ascending single-dose study in 72 healthy subjects, and NCT01519531 was an ascending multiple-dose study in 48 healthy subjects. Both trials were conducted in the United States.

Is VIA-3196 the same as any other drug?

VIA-3196 is the sole name used for this investigational small molecule in its clinical trials. No alternative names have been reported for the drug in the available trial information.