Study Purpose
HERO is a Phase 3, double blind study sponsored by Aardvark Therapeutics to investigate the effects of ARD-101 on hyperphagia-related behavior in people with Prader-Willi Syndrome. This study will compare ARD-101 to a placebo to see if ARD-101 works to treat hyperphagia in PWS.
Eligible participants will take ARD-101 or placebo every day for 12 weeks. Participation will require a visit to the clinic or a tele-visit once every 2-4 weeks during the 12-week study, and one tele-visit 4 weeks after the conclusion of taking ARD-101 or placebo.
Recruitment Criteria
Study Type: Interventional
Eligible Ages: 13 and older
Other Criteria:
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
See the trial listing at clinicaltrials.gov for a full list of inclusion and exclusion criteria.
Trial Details
ClinicalTrials.Gov Id: NCT05153434
Phase: 3
Duration: 12 weeks
Lead Sponsor: Aaardvark Therapeutics
Countries: United States, Australia, Canada, France, Italy, Republic of Korea, Romania, Spain, United Kingdom,
Sites are opening now! To see a list of planned sites and their enrollment status, please visit clinicaltrials.gov
Questions?
Contact: Robin Schmidt, MS
Phone: 858-225-7696
Email: info@aardvarktherapeutics.com
