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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 non-alcoholic steatohepatitis (NASH), a metabolic liver disease. It is not approved for any indication and remains in clinical development. MetaVia Inc. is evaluating it as a potential treatment for patients with presumed NASH.
DA-1241 targets GPR119, a receptor. GPR119 is a G protein-coupled receptor, and DA-1241 is designed as a small molecule agent that acts on this receptor target. Targeting GPR119 is the mechanism under investigation for its use in non-alcoholic steatohepatitis.
DA-1241 is being developed by MetaVia Inc., which trades under the ticker MTVA. The company is the sponsor advancing this small molecule through clinical development for non-alcoholic steatohepatitis, a metabolic therapeutic area.
DA-1241 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 program for non-alcoholic steatohepatitis has completed its trial, and the asset remains in clinical development rather than on the market.
DA-1241 has been studied in the Phase 2 trial NCT06054815, titled Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH. That trial was completed, enrolled 109 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.