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New Study of ARD-101 Now Enrolling Participants Ages 17-65

A new Phase 2 study is now available for eligible participants, ages 17-65, with a confirmed diagnosis of Prader-Willi syndrome.

ARD-101 is a new, oral therapeutic that has shown promising activity in reducing appetite and promoting weight loss in preclinical (animal model) studies. 

FPWR-New-Study-of-ARD-101-Now-Enrolling-ParticipantsThis drug works by targeting bitter taste receptors in the GI tract, where it acts to increase the production of gut peptides hormones that regulate appetite. Importantly, the safety of ARD-101 was documented in a recently completed phase 1 clinical trial in healthy volunteers. The phase 2 study of oral ARD-101 in PWS will evaluate the drug for its safety and effectiveness in treating hyperphagia.

This study is looking to enroll 12 individuals with PWS (ages 17-65 and BMI ≥27 kg/m²) who will take ARD-101 orally, twice daily for 28 days. The study will consist of a screening period, a 28 day treatment period, and a follow-up visit within 14 days after receiving the last dose of ARD-101. 

Two trial sites are planned for this study.  Children’s Hospital, Colorado, under the guidance of Dr. Shawn McCandless, and Stanford Children’s Health, California, under the guidance of Dr. Diane Stafford, are both now open and screening interested participants.  The study is sponsored by Aardvark Therapeutics.

You can learn more about this study on clinicaltrials.gov. More information about how ARD-101 works can be found here. You can also watch a short presentation about the drug and the clinical trial below.

 

FPWR Enewsletter

Topics: Research

Susan Hedstrom

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Susan Hedstrom is the Executive Director for the Foundation for Prader-Willi Research. Passionate about finding treatments for PWS, Susan joined FPWR in 2009 shortly after her son, Jayden, was diagnosed with Prader-Willi Syndrome. Rather than accepting PWS as it has been defined, Susan has chosen to work with a team of pro-active and tireless individuals to accelerate PWS research in order to change the future of PWS. Inspired by her first FPWR conference and the team of researchers that were working to find answers for the syndrome, she joined the FPWR team in 2010 and led the development of the One SMALL Step walk program. Under Susan’s leadership, over $15 million has been raised for PWS related research.