HTD1801 for Non-alcoholic Fatty Liver Disease

(CENTRICITY Trial)

Recruiting at61 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: HighTide Biopharma Pty Ltd

Prior Safety Data

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.

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.

Treatment Details

Interventions

• HTD1801 (Unknown)
• Placebo (Unknown)

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+