ARD-101 as a Potential Treatment for PWS

Study Purpose

This is a Phase 2, open-label study to investigate the effects of ARD-101 in people with Prader-Willi Syndrome.  This study is looking to enroll 12 individuals between the ages of 17 and 65 years. Participants will take ARD-101 orally, twice daily for 28 days.

The study will consist of a Screening Period (up to 28 days), a Treatment Period (28 days), and a Follow-up Period (End-of-Study Visit within 14 days after receiving the last dose of ARD-101). 

You can learn more about this study in a short webinar recorded in October 2021. Watch the presentation below.


Recruitment Criteria

Study Type: Interventional
Eligible Ages: 17-65 years
Other Criteria: 

See the trial listing at for a full list of inclusion and exclusion criteria.


Trial Details

ClinicalTrials.Gov Id: NCT05153434
Phase: 2
Duration:  4 weeks
Lead Sponsor: Aaardvark Therapeutics
Countries: United States


This study will be available at the following sites:  

Stanford University
Palo Alto, CA United States, 94304
Contact: Diane Stafford, MD
Phone: 650-721-1811 Email:

Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Contact: Shawn McCandless, MD                                                                                               


Contact: Andreas Niethammer, MD, Phd
Phone: 858-349-4820



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