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

NCT07197034 | Suspended Phase 3 DMC FDA Drug

• 1 other identifier: AVK-101-302
• Study Type: interventional
• Target: 90
• Locations: 5 countries
• Sites: 30

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.

Conditions

Hyperphagia; Prader-Willi Syndrome; Hyperphagia in Prader-Willi Syndrome

Keywords

Prader-Willi Syndrome; ARD-101; PWS; Prader-Willi; Prader Willi; Prader Willi Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score

  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).

  During treatment period (approximately 12 months)

Secondary Outcomes (1)

• Change in Caregiver Global Impression of Severity (CaGI-S) for Hyperphagia in Prader-Willi patients

  During treatment period (approximately 12 months)

Study Arms (1)

ARD-101

EXPERIMENTAL

(Open-label)

Drug: ARD-101

Interventions

ARD-101 DRUG

200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks

ARD-101

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aardvark Therapeutics, Inc.: lead

Study Sites (30)

Children's of Alabama

Birmingham, Alabama, 35233-1711, United States

Location

Children's Hospital of Orange Country

Orange, California, 92868, United States

Location

Stanford Children's Health Specialty Services

Palo Alto, California, 94304, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Children's Hospital Colorado

Denver, Colorado, 80045-7106, United States

Location

Nemours Children's Clinic Wilmington

Wilmington, Delaware, 19803-3607, United States

Location

UF Shands Children's Hospital

Gainesville, Florida, 32610-3008, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322-1047, United States

Location

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2991, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287-0005, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55102, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219-2918, United States

Location

NYU Langone Children's Ambulatory Care Center

Mineola, New York, 11501-4077, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-0005, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

Alberta Children's Hospital Research Institute

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Children's Hospital at London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Fulborn Hospital

Cambridge, CB21 5EF, United Kingdom

Location

Royal Hospital for Children (Glasgow) - PPDS - PIN

Glasgow, G51 4TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Hyperphagia; Prader-Willi Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 29, 2025
• Study Start: July 23, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); AU (3); GB (4); US (16); KR (3)