HTD1801 for Non-alcoholic Fatty Liver Disease

(CENTRICITY Trial)

Recruiting at 61 trial locations

Overseen By Cathryn Bennett, BN, RN, CCRA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: HighTide Biopharma Pty Ltd

Disqualifiers: Fibrosis stage 4, Alcohol abuse, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 60 weeks

218 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the drug HTD1801 unique for treating non-alcoholic fatty liver disease?

HTD1801 is unique because it is being tested as a potential treatment for non-alcoholic fatty liver disease (NAFLD), a condition for which there are currently no approved drug treatments. This makes HTD1801 a novel option in the landscape of NAFLD therapies. ^{1 2 3 4 5}

Research Team

Adrian Di Bisceglie, MD, FACP, FAASLD

Principal Investigator

Hightide Therapeutics USA, LLC

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with NASH based on a liver biopsy in the last 6 months.

BMI >25 kilograms/meters squared (>23 kilograms/meters squared if Asian).

I was diagnosed with type 2 diabetes or pre-diabetes at least 6 months ago.

Exclusion Criteria

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

I have a history of type 1 diabetes.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HTD1801 or placebo, 1250 mg BID, for up to 60 weeks

60 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• HTD1801
• Placebo

Trial Overview 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.

Participant Groups

Group I: HTD1801 Experimental Treatment 1 Intervention

HTD1801,1250 mg, BID

Group II: placebo Placebo Group 1 Intervention

placebo, BID

Who Is Running the Clinical Trial?

HighTide Biopharma Pty Ltd

Lead Sponsor

Trials

12

Recruited

2,000+

Findings from Research

Non-alcoholic fatty liver disease (NAFLD) is a growing global health issue linked to metabolic disorders, with significant risks for disease progression and mortality, yet there are currently no approved medications for its treatment.

This paper reviews emerging therapeutic strategies and potential drug targets for NAFLD, emphasizing the importance of ongoing clinical trials in developing effective pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for Non-Alcoholic Fatty Liver Disease: Emerging Targets and Drug Candidates. Prikhodko, VA., Bezborodkina, NN., Okovityi, SV.[2023]

In a study of 187 participants with nonalcoholic steatohepatitis (NASH) receiving placebo treatment, 20% showed a significant reduction in liver fat content (PDFF) after 12 weeks, highlighting a notable 'placebo effect' that can impact trial outcomes.

The analysis revealed an average decrease of 2.3 units in absolute PDFF values after 24 weeks of placebo treatment, suggesting that future clinical trials should account for this effect when calculating sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Nedrud, MA., Chaudhry, M., Middleton, MS., et al.[2023]

In a review of 15 randomized controlled trials involving both adults and children, metformin showed a significant effect on normalizing alanine transaminase levels compared to vitamin E, indicating its potential efficacy in treating nonalcoholic fatty liver disease (NAFLD).

While some treatments like pioglitazone showed reduced liver necrosis and inflammation, the overall limited data and methodological issues in the studies prevent definitive conclusions about the efficacy of various pharmacological and dietary interventions for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. Socha, P., Horvath, A., Vajro, P., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for Non-Alcoholic Fatty Liver Disease: Emerging Targets and Drug Candidates. [2023]

2. India pubmed.ncbi.nlm.nih.gov

Drug Development for Nonalcoholic Fatty Liver Disease: Landscape and Challenges. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of antiplatelet drugs against experimental non-alcoholic fatty liver disease. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. [2022]