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

Aardvark Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Prader-Willi Syndrome; Hyperphagia in Prader-Willi Syndrome; Hyperphagia

Treatments: Drug: ARD-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT07197034

AVK-101-302

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

ARD-101

Experimental group

Description:

(Open-label)

Treatment:

Drug: ARD-101