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DA-9801 · 1 trial · 1 indication
Pain score was assessed by the subject using the 11-point Likert rating scale for pain (0=no pain to 10=worst possible pain) prior to conduct of any other study assessment. The change in clinic visit pain score at the 12-week visit was compared to baseline.
| Arm | Type | Description |
|---|---|---|
| DA-9801 300mg | EXPERIMENTAL | DA-9801 will be administered in tablet form, 100mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| DA-9801 600mg | EXPERIMENTAL | DA-9801 will be administered in tablet form, 200 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| DA-9801 900mg | EXPERIMENTAL | DA-9801 will be administered in tablet form, 300 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo (same formulation as DA-9801 but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| DA-9801 300mg | DRUG | 300 mg of DA-9801 in tablet form, 100 mg to be taken 3 times daily for 12 weeks. |
| DA-9801 600mg | DRUG | 600 mg of DA-9801 in tablet form, 200 mg to be taken 3 times daily for 12 weeks. |
| DA-9801 900mg | DRUG | 900 mg of DA-9801 in tablet form, to be taken 300 mg to be taken 3 times daily for 12 weeks. |
| Placebo | DRUG | Placebo, in tablet form, to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient. |
Inclusion Criteria: * Must be 18 to 75 years of age * Diagnosed with Type I or Type II diabetes * HbA1c ≤ 12% at the time of screening * Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the lower extremities for more than 3 months prior to screening and with no adequat...
DA-9801 is an investigational small molecule developed by MetaVia Inc. (ticker MTVA) for diabetic neuropathy, a neurological complication of diabetes. It has been studied in a Phase 2 clinical trial and is not yet approved. The drug is also referred to as DA-9801 300mg.
DA-9801 is being developed to treat diabetic neuropathy, a nerve condition associated with diabetes. Its clinical evaluation has focused on this indication in the neurology therapeutic area. The program remains investigational, with a completed Phase 2 study conducted in the United States.
DA-9801 is developed by MetaVia Inc., which trades under the ticker MTVA. The company is the sponsor of the clinical program evaluating the drug in diabetic neuropathy.
DA-9801 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved for any indication.
DA-9801 has been evaluated in one completed Phase 2 trial, NCT01822925, titled Study of DA-9801 to Treat Diabetic Neuropathy. The trial enrolled 128 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older of all sexes.