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

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

Recruiting
13 years and older
All
Phase 3
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Overview

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.

Eligibility

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 details
    Hyperphagia
    Prader-Willi Syndrome
    Hyperphagia in Prader-Willi Syndrome

NCT07197034

Aardvark Therapeutics, Inc.

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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