Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH
- Conditions
- NON-ALCOHOLIC STEATOHEPATITIS
- Interventions
- Registration Number
- NCT06054815
- Lead Sponsor
- NeuroBo Pharmaceuticals Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Group 1 DA-1241 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 2 Group 3.2 Sitagliptin Placebo 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 DA-1241 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. Part 1 Group 1 DA-1241 Placebo 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 1 Sitagliptin Placebo 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 3.1 DA-1241 Placebo 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 1 Group 2 Sitagliptin Placebo 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 Sitagliptin Placebo 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 DA-1241 Placebo 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 1 Group 2 DA-1241 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 2 Group 4 Sitagliptin 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.
- Primary Outcome Measures
Name Time Method Change alanine transaminase (ALT) levels 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 Outcome Measures
Name Time Method Body weight Baseline to Day 112 Absolute change in body weight.
AST, GGT, ALP Baseline to Day 112 Absolute change in aspartate transaminase (AST), gamma glutamyl transpeptidase (GGT), and alkaline phosphatase (ALP).
Total cholesterol, LDL, HDL, triglyceride, and free fatty acids Baseline to Day 112 Absolute change in total cholesterol, low and high-density lipoprotein cholesterol, triglyceride, and free fatty acids from baseline.
ALT Normalization Baseline to Day 112 Proportion of subjects with normalization of ALT: \< 30 IU/L
Glucose Baseline to Day 112 Absolute change in fasting plasma glucose (mg/dL).
HOMA-IR Baseline to Day 112 Absolute change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
CAP Baseline to Day 112 Absolute change in controlled attenuation parameter (CAP) score assessed by FibroScan®.
A1c Baseline to Day 112 Absolute change in hemoglobin A1c (HbA1c) (%).
Fasting insulin Baseline to Day 112 Absolute change in fasting insulin.
Adipo-IR Baseline to Day 112 Absolute change in adipose tissue insulin resistance index (adipo-IR).
VCTE Baseline to Day 112 Absolute change in vibration-controlled transient elastography (VCTE) score assessed by FibroScan®.
FAST Baseline to Day 112 Absolute change in FibroScan®- AST (FAST) score.
Trial Locations
- Locations (18)
Southern California Research Center
🇺🇸Coronado, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Velocity Clinical Research, Panorama City
🇺🇸Panorama City, California, United States
Inland Empire Clinical Trials, LLC
🇺🇸Rialto, California, United States
Integrity Clinical Research, LLC
🇺🇸Doral, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Clinical Pharmacology of Miami, LLC
🇺🇸Miami, Florida, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
GI Associates & Endoscopy Center
🇺🇸Flowood, Mississippi, United States
AIG Digestive Disease Research
🇺🇸Florham Park, New Jersey, United States
South Texas Research Institute - A Pinnacle Entity
🇺🇸Edinburg, Texas, United States
Dallas Research Institute, LLC
🇺🇸Farmers Branch, Texas, United States
Pinnacle Clinical Research - Georgetown
🇺🇸Georgetown, Texas, United States
Pioneer Research Solutions Inc.
🇺🇸Houston, Texas, United States
American Research Corporation
🇺🇸San Antonio, Texas, United States
Pinnacle Clinical Research - San Antonio
🇺🇸San Antonio, Texas, United States
Apex Mobile Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States