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 clinicaltrials.gov 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: dejs@stanford.edu
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Contact: Shawn McCandless, MD
Questions?
Contact: Andreas Niethammer, MD, Phd
Phone: 858-349-4820
Email: AndreasNiethammer@aardvarktherapeutics.com