ARD-101 for Prader-Willi Syndrome

(HERO Trial)

Recruiting at 40 trial locations

Overseen By Gayatri Nair

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Aardvark Therapeutics, Inc.

Must not be taking: Weight agents, Glucocorticoids

Disqualifiers: Schizophrenia, Bipolar, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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). It will also teach us about the safety of ARD-101. The main questions it aims to answer are: * Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? * What medical problems do participants have when taking ARD-101? Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects. Eligible participants will: * Take ARD-101 or a placebo every day for 12 weeks. * Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo. * Patients/Caregivers will keep a daily diary.

Will I have to stop taking my current medications?

The trial requires that participants stop using medications that promote weight gain or loss, alter hunger or appetite, and glucocorticoids (a type of steroid) within 30 days before starting the study and throughout the study.

Eligibility Criteria

This trial is for patients with Prader-Willi Syndrome who experience intense, persistent hunger (hyperphagia) and may binge eat. Participants will take ARD-101 or a placebo daily for 12 weeks and attend regular clinic visits or tele-visits.

Inclusion Criteria

I have had the same caregiver for at least 6 months.

I have been diagnosed with Prader-Willi Syndrome.

Exclusion Criteria

Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other severe mood, anxiety, or eating disorder (other than hyperphagia)

My child's blood pressure is 140/90 mmHg or higher.

Adults: systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take ARD-101 or a placebo every day for 12 weeks

12 weeks

Visit the clinic or have a tele-visit once every 2 to 4 weeks

Follow-up

Participants have a tele-visit 4 weeks after stopping the ARD-101 or placebo

4 weeks

1 tele-visit

Treatment Details

Interventions

• ARD-101

Trial Overview The study tests if ARD-101 can improve hyperphagia in Prader-Willi Syndrome by comparing it to a placebo. The main measure is the change in the HQCT-9 score, which assesses hyperphagia-related behaviors.

Participant Groups

Group I: Treatment Arm A Experimental Treatment 1 Intervention

ARD-101

Group II: Treatment Arm B Placebo Group 1 Intervention

Placebo for ARD-101

Who Is Running the Clinical Trial?

Aardvark Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

150+