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Aardvark Therapeutics Reaches Alignment With FDA on Broadening Phase 3 Prader-Willi Syndrome Trial Population
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Aardvark Therapeutics Reaches Alignment With FDA on Broadening Phase 3 Prader-Willi Syndrome Trial Population
Oct 8, 2025 6:22 AM

08:35 AM EDT, 10/08/2025 (MT Newswires) -- Aardvark Therapeutics ( AARD ) said Wednesday it reached an alignment with the US Food and Drug Administration on expanding the patient population for its phase 3 trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome.

The expansion changes the minimum age of eligibility to take part in the trial to 10 years old from 13, the company said.

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