A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed Non-alcoholic Steatohepatitis (NASH)
Overview
- Phase
- Phase 2
- Intervention
- DA-1241 Placebo
- Conditions
- NON-ALCOHOLIC STEATOHEPATITIS
- Sponsor
- NeuroBo Pharmaceuticals Inc.
- Enrollment
- 109
- Locations
- 18
- Primary Endpoint
- Change alanine transaminase (ALT) levels
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH).
Detailed Description
Clinical trial DA1241_NASH_IIa is a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, Phase 2a clinical trial to evaluate the efficacy and safety of DA-1241 in subjects with presumed NAFLD. Part 1 of this clinical trial intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 at varying doses or identical placebo in 3 treatment groups for 16 weeks/112 days. Part 2 intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 in combination with sitagliptin versus an identical placebo for 16 weeks/112 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 1 Group 3.1
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.
Intervention: DA-1241 Placebo
Part 1 Group 1
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.
Intervention: DA-1241
Part 1 Group 1
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.
Intervention: DA-1241 Placebo
Part 1 Group 3.1
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.
Intervention: Sitagliptin Placebo
Part 1 Group 1
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.
Intervention: Sitagliptin Placebo
Part 1 Group 2
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.
Intervention: DA-1241
Part 1 Group 2
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.
Intervention: Sitagliptin Placebo
Part 2 Group 3.2
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.
Intervention: DA-1241 Placebo
Part 2 Group 3.2
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.
Intervention: Sitagliptin Placebo
Part 2 Group 4
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.
Intervention: DA-1241
Part 2 Group 4
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.
Intervention: Sitagliptin
Outcomes
Primary Outcomes
Change alanine transaminase (ALT) levels
Time Frame: Baseline to Day 112
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.
Secondary Outcomes
- Adipo-IR(Baseline to Day 112)
- AST, GGT, ALP(Baseline to Day 112)
- Total cholesterol, LDL, HDL, triglyceride, and free fatty acids(Baseline to Day 112)
- CAP(Baseline to Day 112)
- ALT Normalization(Baseline to Day 112)
- Glucose(Baseline to Day 112)
- HOMA-IR(Baseline to Day 112)
- Fasting insulin(Baseline to Day 112)
- A1c(Baseline to Day 112)
- VCTE(Baseline to Day 112)
- FAST(Baseline to Day 112)
- Body weight(Baseline to Day 112)