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DA-1241 · 1 trial · 1 indication
To explore the efficacy (change from baseline in alanine transaminase \[ALT\]) of DA-1241 in subjects at risk of NASH or subjects with non-alcoholic fatty liver disease (NAFLD) after administration of oral DA-1241 at varying doses of placebo and in combination with sitagliptin.
| Arm | Type | Description |
|---|---|---|
| Part 1 Group 1 | EXPERIMENTAL | DA-1241 Dose 1 In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. |
| Part 1 Group 2 | EXPERIMENTAL | DA-1241 Dose 2 In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. |
| Part 1 Group 3.1 | PLACEBO_COMPARATOR | DA-1241 Placebo and Sitagliptin Placebo In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio. |
| Part 2 Group 3.2 | PLACEBO_COMPARATOR | DA-1241 Placebo and Sitagliptin Placebo In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio. |
| Part 2 Group 4 | EXPERIMENTAL | DA-1241 and Sitagliptin In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio. |
| Name | Type | Description |
|---|---|---|
| DA-1241 | DRUG | Route of Administration: Oral, with subjects in a fasting state |
| Sitagliptin | DRUG | Route of Administration: Oral, with subjects in a fasting state |
| DA-1241 Placebo | DRUG | Route of Administration: Oral, with subjects in a fasting state |
| Sitagliptin Placebo | DRUG | Route of Administration: Oral, with subjects in a fasting state |
Inclusion Criteria 1. Subjects who are able to understand and sign informed consent before the conduct of any protocol specific screening procedures. 2. Subjects who are male or female, aged 18 to 75 years inclusive at the time of consent. 3. Female subjects of childbearing potential: 1. Must a...
DA-1241 is an investigational small molecule being developed for the treatment of non-alcoholic steatohepatitis (NASH), a form of fatty liver disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
DA-1241 is being developed by MetaVia Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol MTVA. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with presumed NASH.
DA-1241 is in Phase 2 clinical development. A Phase 2 trial has been completed, which studied the drug in 109 participants with presumed non-alcoholic steatohepatitis. The drug remains investigational and has not received FDA approval.
DA-1241 has one completed Phase 2 clinical trial registered under NCT06054815. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of DA-1241 in 109 subjects with presumed NASH in the United States. Participants were aged 18 years and older.
No, DA-1241 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval for the treatment of non-alcoholic steatohepatitis.