NCT05153434

A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome

A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Aardvark Therapeutics, Inc. · Industry
• Sex: All
• Age: 17 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome

Detailed description

This is a Phase 2, open-label study to investigate the effects of ARD-101 in subjects with Prader-Willi Syndrome. 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). The screening procedures will be initiated upon completion of the informed consent process. Following completion of screening procedures and confirmation of eligibility, subjects will be enrolled to receive ARD-101 in an outpatient setting and will be instructed to visit the clinical center periodically for safety and efficacy assessments.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	ARD-101	Twice Daily, Oral Administration

Timeline

• Start date: 2022-05-27
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2021-12-10
• Last updated: 2025-05-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study