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 oral small molecule drug developed by Aardvark Therapeutics, Inc. for metabolic conditions. It is being studied in obesity, Prader-Willi syndrome, and in adults undergoing bariatric surgery. ARD-101 is investigational and remains in clinical development.
ARD-101 is being developed for obesity, Prader-Willi syndrome, and weight management in adults receiving bariatric surgery. Clinical studies have enrolled adults with obesity, patients with Prader-Willi syndrome, and adults undergoing bariatric surgery. It has not been approved for any indication and remains investigational.
ARD-101 is developed by Aardvark Therapeutics, Inc., which trades under the ticker AARD. The company is the sponsor of the clinical studies evaluating ARD-101 in obesity, Prader-Willi syndrome, and bariatric surgery patients.
ARD-101 is in Phase 2 clinical development. All three of its reported trials are Phase 2 studies, and all have been completed. The drug is investigational and has not been approved by the FDA for any indication.
ARD-101 has been evaluated in three completed Phase 2 trials: NCT05215847 in adults receiving bariatric surgery, NCT05153434 in patients with Prader-Willi syndrome, and NCT05121441 in adults with obesity. All three studies were conducted in the United States.
The ARD-101 clinical program has enrolled a total of 20 participants across its reported trials. The bariatric surgery study NCT05215847 enrolled 12 participants, the Prader-Willi syndrome study NCT05153434 enrolled 19, and the obesity study NCT05121441 enrolled 20.