Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARD-101 · 3 trials · 4 indications
The incidence of treatment emergent adverse events (TEAE) reported through the 28 days of treatment and the 14 days post treatment phase. TEAEs were those events occurring after treatment began.
The percent total weight change at the end of treatment from baseline
| Arm | Type | Description |
|---|---|---|
| ARD-101 (Fixed Dose) | EXPERIMENTAL | ARD-101: 4 weeks dosing at 200 mg BID (twice daily) |
| ARD-101 (Dose Escalation) | EXPERIMENTAL | ARD-101: 1 week at 400 mg BID (twice daily), second week at 600 mg BID, third and fourth weeks at 800 mg BID. Oral administration. |
| ARD-101 | EXPERIMENTAL | Dose 200 mg of ARD-101, twice daily for 28 days |
| Placebo Comparator | PLACEBO_COMPARATOR | Placebo arm matching active arm ARD-101, 200 mg BID |
| Name | Type | Description |
|---|---|---|
| ARD-101 | DRUG | Oral administration of ARD-101 taken BID (twice daily) for 28 days. |
| Placebo | DRUG | Twice daily, oral administration |
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, o...
ARD-101 is an investigational small molecule being studied for metabolic conditions, specifically obesity, Prader-Willi syndrome, and weight management in adults receiving bariatric surgery. It is being developed by Aardvark Therapeutics, Inc. (NASDAQ: AARD) and is currently in Phase 2 clinical development.
ARD-101 is being developed by Aardvark Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker AARD. The company is conducting clinical trials of ARD-101 in the United States for obesity, Prader-Willi syndrome, and bariatric surgery-related weight gain.
ARD-101 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Three Phase 2 trials have been completed, each evaluating the drug in a different metabolic condition: obesity, Prader-Willi syndrome, and bariatric surgery patients.
ARD-101 has completed three Phase 2 clinical trials in the United States. NCT05121441 evaluated ARD-101 in 20 adults with obesity. NCT05153434 studied ARD-101 in 19 patients with Prader-Willi syndrome. NCT05215847 assessed ARD-101 in 12 adults receiving bariatric surgery for obesity and weight gain.
ARD-101 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA. These designations are granted for drugs intended to treat rare diseases, supporting the development of ARD-101 for Prader-Willi syndrome, a rare genetic disorder.
ARD-101 is the sole name provided for this investigational drug. No alternative names or brand names have been associated with it in the available clinical trial information. It is a small molecule being developed by Aardvark Therapeutics for metabolic indications.