ARD-101 for Prader-Willi Syndrome

Recruiting at 41 trial locations

Overseen By Vanessa Wong

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Aardvark Therapeutics, Inc.

Disqualifiers: Complications, others

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

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: 5

Duration: 12 months

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ARD-101 for individuals with Prader-Willi syndrome, focusing on reducing hyperphagia-related behavior, which involves excessive eating. The trial aims to determine if long-term use of ARD-101 is safe and effective in improving eating behaviors. Participants must have completed a previous related study with ARD-101. They will take the treatment daily for up to a year and attend regular clinic visits to monitor progress. Candidates should be prepared to maintain a daily diary about their experience. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that ARD-101 is likely to be safe for humans?

Research has shown that ARD-101 has undergone safety testing in earlier trials. One study found that ARD-101 was safe and well tolerated by healthy adults. Another study discovered that ARD-101 primarily works in the stomach area while still affecting the whole body. This finding is promising because it might mean fewer side effects. These studies suggest that ARD-101 is generally safe, but monitoring for any health issues during its use remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Prader-Willi Syndrome, which often involve hormone therapy and appetite suppressants, ARD-101 offers a novel approach by targeting the brain’s reward center. This experimental drug aims to regulate appetite and weight by influencing how the brain processes hunger signals. Researchers are excited about ARD-101 because it has the potential to address the root cause of excessive hunger, a major challenge in managing Prader-Willi Syndrome, offering hope for improved quality of life for patients.

What evidence suggests that ARD-101 might be an effective treatment for Prader-Willi syndrome?

Research has shown that ARD-101, the investigational treatment in this trial, may help reduce excessive hunger in people with Prader-Willi Syndrome (PWS). In an earlier study, 11 out of 12 patients felt less hungry after just 28 days, and four of them almost completely stopped feeling excessively hungry. ARD-101 might work by increasing the body's production of a gut hormone called CCK, which helps control hunger. These results suggest that ARD-101 could effectively manage excessive hunger in PWS patients. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Prader-Willi Syndrome who have issues with overeating and have completed the AVK-101-301 study. They must be able to take ARD-101 daily for up to a year, visit the clinic at specified intervals, and maintain a daily diary.

Inclusion Criteria

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

Exclusion Criteria

Any complications that make participation unsafe in the Investigator's opinion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take ARD-101 every day for up to 12 months to assess its efficacy and safety in treating hyperphagia-related behavior in Prader-Willi syndrome

12 months

Clinic visits at Months 1, 3, 6, and 12; tele-visits at Week 2, Months 3 and 9

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Tele-visit 4 weeks after stopping ARD-101

What Are the Treatments Tested in This Trial?

Interventions

• ARD-101

Trial Overview The HERO OLE trial is testing if ARD-101 can manage hyperphagia (excessive eating) in Prader-Willi Syndrome over the long term. It involves regular clinic visits and tele-visits, assessing changes using the HQCT-9 score.

How Is the Trial Designed?

Group I: ARD-101 Experimental Treatment 1 Intervention

(Open-label)

Who Is Running the Clinical Trial?

Aardvark Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

150+

Citations

1. ir.aardvarktherapeutics.com ir.aardvarktherapeutics.com/news-releases/news-release-details/aardvark-therapeutics-reports-positive-phase-ii-clinical-data

Aardvark Therapeutics Reports Positive Phase II Clinical ... Prader-Willi Syndrome: This was an open label study where 11 of 12 patients showed a reduction in hyperphagia in only 28 days using the HQ-CT ( ...

2. fpwr.org fpwr.org/blog/exploring-the-hero-trial-investigating-ard-101-for-hyperphagia-in-pws

Exploring the HERO Trial: Investigating ARD‑101 ... Promising Phase 2 Results · Out of 12 participants, 11 showed reduced hyperphagia, and 4 achieved near-complete symptom relief. · ARD‑101 also ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05153434

NCT05153434 | A Study of Oral ARD-101 in Patients With ... This is a Phase 2, open-label study to investigate the effects of ARD-101 in subjects with Prader-Willi Syndrome.

4. horizonscandb.pcori.org horizonscandb.pcori.org/report/topics/923

ARD-101 to treat hyperphagia associated with Prader-Willi ... If ARD-101 can restore the ability to secrete gut CCK in patients with PWS, this might restore normal satiety and reduce food intake. In a phase ...

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/aardvark-gets-fda-alignment-for-prader-willi-phase-3-trial/

Aardvark Gets FDA Alignment for Prader-Willi Phase 3 Trial Aardvark Therapeutics lowered the minimum age of eligibility in its Phase 3 HERO trial of ARD-101 for hyperphagia in Prader–Willi syndrome ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06828861

NCT06828861 | ARD-101 for Treatment of PWS: The ... 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).

7. fpwr.org fpwr.org/blog/pws-clinical-trials-2025-conference-recap-and-how-families-can-help

PWS Clinical Trials: 2025 Conference Recap and How ... Mechanism: ARD-101 is an oral investigational therapy designed to act in the gut. · Phase 2 signals: Early improvement in hyperphagia, including ...

8. praderwillinews.com praderwillinews.com/ard-101-for-prader-willi-syndrome/

ARD-101 for Prader-Willi syndrome After a Phase 1 clinical trial showed that ARD-101 was safe and well tolerated in healthy adults, the investigational treatment was tested in a ...