Status:

RECRUITING

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

Lead Sponsor:

Aardvark Therapeutics, Inc.

Conditions:

Hyperphagia

Prader-Willi Syndrome

Eligibility:

All Genders

13+ years

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

July 23 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT07197034

Start Date

July 23 2024

End Date

April 1 2027

Last Update

January 8 2026

Active Locations (42)

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Page 1 of 11 (42 locations)

1

Children's of Alabama

Birmingham, Alabama, United States, 35233-1711

2

Stanford Children's Health Specialty Services

Palo Alto, California, United States, 94304

3

Rady Children's Hospital

San Diego, California, United States, 92123

4

Children's Hospital Colorado

Denver, Colorado, United States, 80045-7106