What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH) similar to HTD1801 include bile acid derivatives like obeticholic acid. Known side effects of these treatments can include pruritus (itching), fatigue, headache, and gastrointestinal symptoms such as nausea and diarrhea. Additionally, some patients may experience elevated cholesterol levels and liver enzyme abnormalities. It is important to monitor these side effects and discuss them with a healthcare provider to manage and mitigate any adverse effects effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) or Non-alcoholic Steatohepatitis (NASH). However, several drugs are under investigation, including bile acid derivatives like obeticholic acid, which has shown promise in reducing liver fibrosis in NASH patients. Other investigational treatments include drugs targeting metabolic pathways, inflammation, and fibrosis, such as resmetirom and elafibranor. These treatments aim to improve liver function and metabolic parameters, similar to the potential effects of HTD1801.

What other types of research exist?

Promising novel alternatives to HTD1801 for NAFLD/NASH patients include: 1) CM-101, a monoclonal antibody targeting CCL24, which has shown antifibrotic and anti-inflammatory effects in experimental models. 2) SR9238, a liver-selective LXR inverse agonist, which suppresses hepatic lipogenesis, inflammation, and lipid accumulation. 3) CTD-002, which modulates extracellular Cathepsin D, reducing hepatic steatosis and improving liver function markers. These treatments are in various stages of research and show potential for improving liver health in NAFLD/NASH patients.

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HTD1801 for Non-alcoholic Fatty Liver Disease (CENTRICITY Trial)

Phase 2

Recruiting

Research Sponsored by HighTide Biopharma Pty Ltd

Eligibility Criteria Checklist

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

Must have

Histologic evidence of fibrosis stage 2 or stage 3 as defined by the non-alcoholic steatohepatitis (NASH) critical ranking number (CRN) scoring of fibrosis.

Be older than 18 years old

Must not have

Fibrosis stage 4.

Liver disease unrelated to non-alcoholic steatohepatitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 weeks

Summary

This trial is testing HTD1801, a medication, to see if it can help adults with NASH and liver fibrosis who also have type 2 diabetes or pre-diabetes. The goal is to see if the medication can reduce liver inflammation and scarring, thereby improving liver health.

Who is the study for?

This trial is for adults with a body mass index (BMI) over 25 (or over 23 if Asian), who have non-alcoholic steatohepatitis (NASH) with liver fibrosis, and type 2 diabetes or pre-diabetes. Participants must have had these conditions diagnosed at least six months prior to the study and cannot have severe heart disease, type 1 diabetes, substance abuse history, other liver diseases, or be unwilling to undergo liver biopsies.

What is being tested?

The study is testing HTD1801 against a placebo in people with NASH and liver fibrosis who also have type 2 diabetes or pre-diabetes. It's a phase 2b trial where participants are randomly assigned to either receive HTD1801 or a placebo without knowing which one they're getting.

What are the potential side effects?

While specific side effects of HTD1801 aren't listed here, common side effects from similar medications may include gastrointestinal issues like nausea and diarrhea, potential changes in blood sugar levels for diabetics, fatigue, headache, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My liver fibrosis is at stage 2 or 3 according to NASH criteria.

Exclusion Criteria

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

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My condition is at the most advanced stage of scarring of the liver.

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My liver disease is not due to non-alcoholic fatty liver disease.

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I have a history of serious heart problems.

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I have a history of type 1 diabetes.

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I cannot or do not want to have the required liver biopsies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Endpoint

Secondary study objectives

Endpoint 1

Endpoint 10

Endpoint 11

+25 more

Side effects data

From 2020 Phase 2 trial • 59 Patients • NCT03333928

Influenza Like Illness

Pruritus

Pyrexia

Limb Injury

Influenza

Hair Texture Abnormal

Lumbar Radiculopathy

Hot Flush

Joint Injury

Lipoma

Intervertebral Disc Protrusion

Myalgia

Cholangitis

Fatigue

Neutropenia

Headache

Abdominal pain upper

Cervical Radiculopathy

Arthralgia

Abdominal pain

Sinusitis

Rosacea

Rash

Urticaria

Chills

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

500mg HTD1801 Bid

1000mg HTD1801 Bid

Placebo Bid

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HTD1801Experimental Treatment1 Intervention

HTD1801,1250 mg, BID

Group II: placeboPlacebo Group1 Intervention

placebo, BID

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HTD1801

2018

Completed Phase 2

~310

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) target reducing liver fat, inflammation, and fibrosis, which are crucial for improving liver function and metabolic health. Bile acid derivatives like HTD1801 work by modulating lipid metabolism, decreasing inflammatory responses, and preventing fibrotic changes in the liver. This is particularly important for NAFLD patients with type 2 diabetes or pre-diabetes, as these treatments can improve insulin sensitivity and overall metabolic parameters, thereby addressing both liver and systemic metabolic dysfunctions.

Cordycepin attenuates high-fat diet-induced non-alcoholic fatty liver disease via down-regulation of lipid metabolism and inflammatory responses.Inhibition of 11β-HSD1 with RO5093151 for non-alcoholic fatty liver disease: a multicentre, randomised, double-blind, placebo-controlled trial.