ARD-101 for Prader-Willi Syndrome

Recruiting at 1 trial location

Overseen By Andreas Niethammer, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Aardvark Therapeutics, Inc.

Must not be taking: Weight loss agents

Disqualifiers: Schizophrenia, Bipolar, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

19 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome

Eligibility Criteria

This trial is for individuals aged 17-65 with Prader-Willi Syndrome, a stable body weight, and no history of severe mental health issues or substance abuse. Participants must not be on insulin but can use certain other diabetes medications if doses have been stable. They should not have significant organ disease or recent medical treatments that could affect the study.

Inclusion Criteria

I was treated with ARD-101 and 3 months have passed since my last dose.

Your blood sugar level when you haven't eaten is less than 140 mg/dL.

You have a high score on a specific test called HQ-CT.

Exclusion Criteria

You have had serious thoughts about hurting yourself or trying to end your own life.

You have a PHQ-9 score of 10 or higher.

I have not had any serious illnesses in the last 8 weeks.

Treatment Details

Interventions

• ARD-101

Trial Overview The trial is testing ARD-101, an oral medication for Prader-Willi Syndrome. It's a Phase 2 study where all participants receive the drug to see how safe it is and how well it works (since there's no comparison group).

Participant Groups

Group I: ARD-101 Experimental Treatment 1 Intervention

First week 400 mg of ARD-101 twice daily, second week 600 mg of ARD-101 twice daily, third week 800 mg of ARD-101 twice daily, fourth week 800 mg of ARD-101 twice daily.

Who Is Running the Clinical Trial?

Aardvark Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

150+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+