CompletedPhase 2

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

United States19 participantsStarted 2022-05-27

Plain-language summary

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

Age range17 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Hemoglobin A1c (HbA1c) \<7.5% not being managed with insulin. Patients taking glucagon-like peptide (GLP)-1 analogues (exenatide or liraglutide) must have been on stable dose for greater than 3 months.
✓. Fasting plasma glucose \<140 mg/dL during the Screening Period
✓. No history of ketoacidosis or hyperosmolar coma
✓. 95 mmHg \<systolic blood pressure (SBP) \<160 mmHg
✓. 45 mmHg \<diastolic blood pressure (DBP) \<100 mmHg
✓. 40 bpm \<heart rate (HR) \<100 bpm

Incidence of Treatment-Emergent Adverse Events (TEAE)

Timeframe: Baseline to Day 28

NCT IDNCT05153434

SponsorAardvark Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-24