ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial (HERO)

Aardvark Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Prader-Willi Syndrome; Hyperphagia

Treatments: Drug: ARD-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06828861

AVK-101-301

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented confirmation of Prader-Willi Syndrome (PWS)
• Stable care setting with same, single designated caregiver for at least 6 months prior to Visit 1

Exclusion criteria

• Diagnosis of schizophrenia, bipolar disorder, personality disorder or other severe mood, anxiety or eating disorder (other than hyperphagia).
• Presence of any malignancy within 5 years with the exception of basal or squamous cell carcinoma of the skin, in situ carcinoma of the service, or in situations prostate cancer.
• Presence of clinically relevant renal, hepatic, pancreatic, cardiovascular, neurological, psychiatric, hematological, pulmonary, or GI abnormality that, in the opinion of the investigator, may preclude the patient from safe completion of the study
• Adults: systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg
• Children and Adolescents: systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg.
• Type 1 diabetes mellitus; HbA1c >8.5%
• Use of agents to promote weight gain or loss, alter hunger or appetite within 30 days of Visit 1 and throughout the study.
• Use of glucocorticoids: oral, intra-articular, or intravenous

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Treatment Arm A

Experimental group

Description:

ARD-101

Treatment:

Drug: ARD-101

Treatment Arm B

Placebo Comparator group

Description:

Placebo for ARD-101

Treatment:

Drug: Placebo