MedTrace Logo

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

NCT07197034 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-19

No results posted yet for this study

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

Interventions

DRUG

ARD-101

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

Sponsors & Collaborators

  • Aardvark Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-23
Primary Completion
2027-03-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07197034 on ClinicalTrials.gov