19 Participants Needed

ARD-101 for Prader-Willi Syndrome

Recruiting at 1 trial location
AN
Overseen ByAndreas Niethammer, MD, PhD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Aardvark Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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

Are You a Good Fit for This Trial?

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.
See 14 more

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.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive ARD-101 in increasing doses over 4 weeks

4 weeks
Periodic visits for safety and efficacy assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
End-of-Study Visit within 14 days after last dose

What Are the Treatments Tested in This Trial?

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).
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ARD-101Experimental Treatment1 Intervention

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
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