ARD-101 for Prader-Willi Syndrome

(HERO Trial)

Recruiting at 52 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ARD-101, an experimental treatment, can reduce overeating behaviors in people with Prader-Willi syndrome (PWS), a condition that causes intense hunger. Researchers aim to determine if ARD-101 improves results on a specific appetite questionnaire and identify any side effects. Participants will receive either ARD-101 or a placebo, a substance resembling the drug but inactive, for 12 weeks. Those with confirmed Prader-Willi syndrome and a stable caregiver for at least six months may qualify for this trial. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

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

Research has shown that ARD-101 is generally safe and well-tolerated in people. In a previous study, the drug primarily remained in the gut, indicating it works mainly in the digestive system. However, it still affects the whole body by triggering the release of certain gut hormones. This is promising for safety, as it limits the drug's contact with other body parts, potentially reducing side effects.

Earlier studies found that ARD-101 was safe for healthy adults and had positive effects on individuals with Prader-Willi Syndrome (PWS). Some participants experienced early improvements in their eating habits, which is encouraging for those with PWS. While taking any drug can cause some medical issues, ARD-101 has not shown any major side effects in these studies so far.

The current trial is in Phase 3, a more advanced stage, indicating strong evidence already supports the safety of ARD-101. This phase typically involves more participants to confirm the drug's safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Prader-Willi syndrome?

Unlike the standard treatments for Prader-Willi Syndrome, which often involve hormone therapy and appetite suppressants, ARD-101 is unique because it targets the brain's pathways that influence hunger and satiety. This new mechanism of action could help manage the insatiable appetite characteristic of this condition more effectively. Researchers are excited about ARD-101 because it offers a novel approach to addressing the core symptoms of Prader-Willi Syndrome, potentially leading to 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, which participants in this trial may receive, may help reduce extreme hunger in people with Prader-Willi Syndrome (PWS). In an earlier study, 11 out of 12 patients experienced reduced hunger after just 28 days. Impressively, 4 of those patients almost completely stopped feeling overly hungry. ARD-101 might work by helping the gut send "I'm full" signals, which could help control overeating. These results suggest that ARD-101 could be a promising treatment for managing hunger-related behaviors in PWS. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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 ...