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

NCT06054815 | Completed Phase 2 FDA Drug

• 1 other identifier: DA1241_NASH_IIa
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 18

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).

Conditions

NON-ALCOHOLIC STEATOHEPATITIS

Keywords

NASH; NON-ALCOHOLIC STEATOHEPATITIS

Outcome Measures

Primary Outcomes (1)

• Change alanine transaminase (ALT) levels

  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.

  Baseline to Day 112

Secondary Outcomes (12)

• ALT Normalization

  Baseline to Day 112

• AST, GGT, ALP

  Baseline to Day 112

• Total cholesterol, LDL, HDL, triglyceride, and free fatty acids

  Baseline to Day 112

• A1c

  Baseline to Day 112

• Glucose

  Baseline to Day 112

Study Arms (5)

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.

Drug: DA-1241; Drug: DA-1241 Placebo; Drug: Sitagliptin Placebo

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.

Drug: DA-1241; Drug: Sitagliptin Placebo

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.

Drug: DA-1241 Placebo; Drug: Sitagliptin Placebo

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.

Drug: DA-1241 Placebo; Drug: Sitagliptin Placebo

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.

Drug: DA-1241; Drug: Sitagliptin

Interventions

DA-1241 DRUG

Route of Administration: Oral, with subjects in a fasting state

Part 1 Group 1; Part 1 Group 2; Part 2 Group 4

Sitagliptin DRUG

Route of Administration: Oral, with subjects in a fasting state

Part 2 Group 4

DA-1241 Placebo DRUG

Route of Administration: Oral, with subjects in a fasting state

Part 1 Group 1; Part 1 Group 3.1; Part 2 Group 3.2

Sitagliptin Placebo DRUG

Route of Administration: Oral, with subjects in a fasting state

Part 1 Group 1; Part 1 Group 2; Part 1 Group 3.1; Part 2 Group 3.2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are able to understand and sign informed consent before the conduct of any protocol specific screening procedures.
• Subjects who are male or female, aged 18 to 75 years inclusive at the time of consent.
• Female subjects of childbearing potential:
• Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last dose of study drug.
• Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last dose of the study drug:
• True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence \[eg, calendar, ovulation, symptothermal, post ovulation methods\] and withdrawal are not acceptable).
• Combined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.
• Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.
• Bilateral tubal occlusion/ligation.
• Intrauterine device (IUD).
• Intrauterine hormone releasing system (IUS).
• Vasectomized partner.
• Female subjects of non-childbearing potential do not need to use birth control during or after study drug treatment if considered of non-childbearing potential due to any of the following criteria:
• Premenopausal female with permanent sterility or permanent infertility as due to one of the following:
• Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy.

You may not qualify if:

• Subjects who have used an investigational agent within 30 days or 5 elimination half-lives; whichever is longer prior to the first Screening Period visit.
• Subjects diagnosed with liver disease other than NASH (eg, chronic viral hepatitis, decompensated cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1-antitrypsin deficiency, primary biliary cholangitis, drug-induced liver disease).
• Subjects who have a positive test result for hepatitis A virus immunoglobulin M, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or reactive human immunodeficiency virus (HIV) after providing a qualifying ALT result at the first Screening Period visit, or who have a known history of HIV infection. However, subjects with a positive hepatitis C virus antibody could be eligible after undergoing reflex testing (HCV-RNA negative) and evaluation by the Investigator.
• Clinically significant laboratory results as evaluated by the Investigator after providing a qualifying ALT result at the first Screening Period visit. Subjects will be excluded if:
• AST ≥ 200 U/L
• Platelets ≤ 150,000/mm3
• Albumin \< 3.8 g/dL
• Total bilirubin ≥ 1.5 mg/dl, except with clinical diagnosis of Gilbert's syndrome
• Direct bilirubin \> 0.3 mg/dL
• Phosphatidylethanol \> 40 ng/mL
• INR \> 1.3 in the absence of anticoagulants
• Subjects with an estimated glomerular filtration rate \< 60 mL/min/1.73m2 based on modification of Diet in Renal Disease (MDRD) formula.
• Subjects with a corrected QT interval by Fridericia (QTcF) of \> 450 ms in males, and \> 470 ms in females.
• Subjects who are taking one or more of the following medications:
• Within 12 weeks prior to the first Screening Period visit: i. Medication that is known to cause or worsen fatty liver disease (amiodarone, valproate, tamoxifen, methotrexate, etc.) for \> 14 days. ii. Medication for weight loss. iii. Chronic use of systemic corticosteroids for \> 14 days; however, administration of intranasal, topical, or inhaled corticosteroids is allowed. iv. DPP-4 inhibitors, thiazolidinediones (TZDs), or GLP-1 agonists.

Sponsors & Collaborators

• NeuroBo Pharmaceuticals Inc.: lead

Study Sites (18)

Southern California Research Center

Coronado, California, 92118, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Velocity Clinical Research, Panorama City

Panorama City, California, 91402, United States

Location

Inland Empire Clinical Trials, LLC

Rialto, California, 92377, United States

Location

Integrity Clinical Research, LLC

Doral, Florida, 33122, United States

Location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

GI Associates & Endoscopy Center

Flowood, Mississippi, 39232, United States

Location

AIG Digestive Disease Research

Florham Park, New Jersey, 07932, United States

Location

South Texas Research Institute - A Pinnacle Entity

Edinburg, Texas, 78539, United States

Location

Dallas Research Institute, LLC

Farmers Branch, Texas, 75234, United States

Location

Pinnacle Clinical Research - Georgetown

Georgetown, Texas, 78626, United States

Location

Pioneer Research Solutions Inc.

Houston, Texas, 77099, United States

Location

American Research Corporation

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

Location

Apex Mobile Clinical Research, LLC

San Antonio, Texas, 78258, United States

Location

Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

DA-1241; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 26, 2023
• Study Start: September 14, 2023
• Primary Completion: October 24, 2024
• Study Completion: October 30, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)