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ARD-101

Phase 2

Bariatric Surgery | Small molecule | Metabolic |Aardvark Therapeutics, Inc.|Last Updated: Feb 11, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05215847Study to Evaluate ARD-101 in Adults Receiving Bariatric SurgeryPHASE2 COMPLETED 12 — — Mar 1, 2022Feb 3, 2023Feb 11, 20251 United States
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Study Endpoints
Primary Endpoints
Relative Change in Body Weight (%)
Baseline and Day 28

The percent total weight change at the end of treatment from baseline

Secondary Endpoints
Incidence of Treatment-emergent Adverse Events (TEAE)
Days 1-28
Change in Blood Lipid Concentrations
Run-in Visit (baseline), Day 28
Change in Waist Circumference
Baseline and Day 28
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARD-101EXPERIMENTALDose 200 mg of ARD-101, twice daily for 28 days
Interventions
NameTypeDescription
ARD-101DRUGTwice daily, oral administration
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female subjects, 18-75 years of age * Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures * Body Mass Index (BMI) of 35-60 kg/m2 during the Screening Period * Stat...

Countries:United States
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