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DA-1241 + Sitagliptin for Non-alcoholic Fatty Liver Disease

Verified Trial

Phase 2

Recruiting

Research Sponsored by NeuroBo Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- 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).

- Bilateral tubal occlusion/ligation.

Must not have

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 with an estimated glomerular filtration rate < 60 mL/min/1.73m2 based on modification of Diet in Renal Disease (MDRD) formula.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 112

Summary

This trial tests if a new drug is safe and effective for people with NASH, a liver disease.

Who is the study for?

Adults aged 18-75 with presumed non-alcoholic steatohepatitis (NASH), a BMI over 23, and specific liver fat content on MRI. They must have stable medication doses if taking certain drugs and agree to contraception requirements. Excluded are those with other liver diseases, recent investigational drug use, or significant lab abnormalities.

What is being tested?

The trial is testing the effectiveness and safety of DA-1241 compared to placebo in treating NASH. It's a Phase 2a study where participants are randomly assigned to receive either DA-1241 or placebo in a double-blind manner, meaning neither they nor the researchers know who gets which treatment.

What are the potential side effects?

Potential side effects for DA-1241 aren't specified but may include typical drug reactions such as gastrointestinal discomfort, headaches, fatigue, allergic reactions or skin issues. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I practice true abstinence as part of my lifestyle.

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I have had both of my fallopian tubes surgically blocked.

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I am permanently sterile due to surgery.

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I am a postmenopausal woman with no periods for 12+ months and high FSH levels.

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I have been diagnosed with NASH or have conditions similar to NASH.

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My liver has at least 8% fat, confirmed by MRI and ALT tests.

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My statin dose has been stable for at least 8 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have liver diseases like hepatitis or cirrhosis, only NASH.

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My kidney function is reduced, with a filtration rate below 60 mL/min.

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I have not taken medications like amiodarone or tamoxifen for more than 14 days.

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I am taking medication to lose weight.

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I haven't taken Digoxin or certain strong medications affecting drug metabolism recently.

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I have a severe liver condition with complications or a high MELD score.

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I have had weight loss surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 112

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 112

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 112 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change alanine transaminase (ALT) levels

Secondary study objectives

A1c

ALT Normalization

AST, GGT, ALP

+9 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2 Group 4Experimental Treatment2 Interventions

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.

Group II: Part 1 Group 2Experimental Treatment2 Interventions

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.

Group III: Part 1 Group 1Experimental Treatment3 Interventions

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.

Group IV: Part 2 Group 3.2Placebo Group2 Interventions

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.

Group V: Part 1 Group 3.1Placebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DA-1241

2018

Completed Phase 1

~170

Sitagliptin Placebo

2009

Completed Phase 3

~320