Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH

Conditions

• NON-ALCOHOLIC STEATOHEPATITIS

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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).

Key Dates

First listed

Sep 26, 2023

Start date

Sep 14, 2023

Status verified

Nov 2024

Primary completion

Oct 24, 2024

Completion

Oct 30, 2024

Study Design

Enrollment

109 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.
• Placebo Comparator: 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.
• Placebo Comparator: 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.
• Experimental: 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.

Primary Outcome Measure

Change alanine transaminase (ALT) levels [ Time Frame: Baseline to Day 112 ]

Locations (18)

Find similar trials in Coronado, CA

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