The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial

Not Applicable

Recruiting

• Conditions: Hyperphagia; Prader-Willi Syndrome; Hyperphagia in Prader-Willi Syndrome
• Interventions: Drug: ARD-101

• Registration Number: NCT07197034
• Lead Sponsor: Aardvark Therapeutics, Inc.

Brief Summary

The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS) when used in a long term setting. It will also teach us about the safety of ARD-101.

The main questions it aims to answer are:

What medical problems do participants have when taking ARD-101 in a long term setting

Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)?

Eligible participants will:

Have completed treatment on the AVK-101-301 study through Week 12/End of Treatment

Take ARD-101 every day for up to 12 months.

Visit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101.

Patients/Caregivers will keep a daily diary.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-23
• Status Verified: 2025-09
• Study First Submitted: 2025-09-21
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2027-03
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients who have completed treatment on Aardvark Therapeutics clinical study AVK-101-301

Exclusion Criteria

• Any complications that makes participation unsafe in the Investigator's opinion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARD-101	ARD-101	(Open-label)

Primary Outcome Measures

Name	Time	Method
Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score	During treatment period (approximately 12 months)	The HQ-CT score is a 9 question, 5-point scale to describe the PWS patient's hyperphagia food-related problem behaviors. It is completed by the patient's caregiver. Each question is scored from 0 to 4. The minimum total score is 0 (hyperphagia related behavior symptoms not exhibited) and the maximum total score is 36 (hyperphagia related behavior symptoms are observed).

Secondary Outcome Measures

Name	Time	Method
Change in Caregiver Global Impression of Severity (CaGI-S) for Hyperphagia in Prader-Willi patients	During treatment period (approximately 12 months)	The CaGI-S is a single-item, 7-point scale to describe the severity of the PWS patient's hyperphagia (excessive hunger). It is completed by the patient's caregiver. The minimum score is 1 (not present) and the maximum score is 7 (extremely severe). A higher score indicates a worse severity of hyperphagia.

Trial Locations

Locations (36)

Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States

Stanford Children's Health Specialty Services; 🇺🇸 Palo Alto, California, United States

Rady Children's Hospital; 🇺🇸 San Diego, California, United States

Children's Hospital Colorado; 🇺🇸 Denver, Colorado, United States

Nemours Children's Clinic Wilmington; 🇺🇸 Wilmington, Delaware, United States

UF Shands Children's Hospital; 🇺🇸 Gainesville, Florida, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

University of Minnesota Masonic Children's Hospital; 🇺🇸 Minneapolis, Minnesota, United States

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

NYU Langone Children's Ambulatory Care Center; 🇺🇸 Mineola, New York, United States

Scroll for more (26 remaining)