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A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome

CompletedPhase 2

Sponsor: Aardvark Therapeutics, Inc.

Conditions: Prader-Willi Syndrome

Interventions: ARD-101

Countries: United States

A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome

Eligibility overview

Sex: ALL

Age: 17 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male and female subjects, 17-65 years of age
* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of participant); provide voluntary, written assent (participants, as appropriate)
* PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or methylation studies
* BMI ≥ 18.5 kg/m²
* Qualifying HQ-CT score

Exclusion Criteria:

* Use of weight loss agents, including herbal medication, within 3 months prior to enrollment
* Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other DSM-III disorders which the investigator believes will interfere significantly with study compliance
* Clinically significant illness in the 8 weeks prior to enrollment
* Current, clinically significant liver, renal, pulmonary, cardiac, oncologic, or gastrointestinal (GI) disease
* Diagnosis of type 1 diabetes mellitus or other active endocrine disorders (e.g., Cushing syndrome, or thyroid dysfunction except if on stable adequate thyroid or glucocorticoid replacement supplement)
* Significant history of abuse of drugs within 1 year prior to enrollment or a positive Drugs of Abuse (DOA) test at screening
* History of alcohol abuse within 1 year prior to enrollment or currently drinks in excess of 21 units per week (3 servings or units/day)

Locations (2)

Palo Alto, California, United States
Aurora, Colorado, United States