Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARD-101 · 3 trials · 4 indications
The incidence of treatment-emergent adverse events (TEAE) during the treatment period
The percent total weight change at the end of treatment from baseline
| Arm | Type | Description |
|---|---|---|
| ARD-101 | EXPERIMENTAL | First week 400 mg of ARD-101 twice daily, second week 600 mg of ARD-101 twice daily, third week 800 mg of ARD-101 twice daily, fourth week 800 mg of ARD-101 twice daily. |
| Placebo Comparator | PLACEBO_COMPARATOR | Placebo arm matching active arm ARD-101, 200 mg BID |
| Name | Type | Description |
|---|---|---|
| ARD-101 | DRUG | Twice Daily, Oral Administration |
| 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 developed for metabolic conditions, including obesity, Prader-Willi syndrome, and weight management in adults receiving bariatric surgery. It is currently in Phase 2 clinical development and has not been approved by the FDA.
ARD-101 is being developed by Aardvark Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol AARD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in metabolic disorders.
ARD-101 is in Phase 2 clinical development. It has completed three Phase 2 trials, including studies in obesity, Prader-Willi syndrome, and bariatric surgery patients. The drug is investigational and has not received FDA approval.
ARD-101 has completed three Phase 2 trials: NCT05121441 in adults with obesity, NCT05153434 in patients with Prader-Willi syndrome, and NCT05215847 in adults receiving bariatric surgery. All trials were conducted in the United States and are now completed.
ARD-101 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA. These designations are granted to drugs intended to treat rare diseases and may provide development incentives.
ARD-101 is the sole name provided for this investigational drug. No alternative names or brand names have been reported for this compound in the available clinical trial information.