← Back to Search

Unknown

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 weeks
Awards & highlights

CENTRICITY Trial Summary

This trial tests a drug to treat liver disease in adults with diabetes or pre-diabetes.

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.Check my eligibility
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.See study design
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.

CENTRICITY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver fibrosis is at stage 2 or 3 according to NASH criteria.

CENTRICITY Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint
Secondary outcome measures
Endpoint 1
Endpoint 10
Endpoint 11
+25 more

Side effects data

From 2020 Phase 2 trial • 59 Patients • NCT03333928
9%
Pruritus
9%
Pyrexia
9%
Influenza Like Illness
5%
Hot Flush
5%
Rosacea
5%
Myalgia
5%
Rash
5%
Intervertebral Disc Protrusion
5%
Limb Injury
5%
Cholangitis
5%
Abdominal pain
5%
Abdominal pain upper
5%
Urticaria
5%
Cervical Radiculopathy
5%
Lipoma
5%
Joint Injury
5%
Sinusitis
5%
Influenza
5%
Hair Texture Abnormal
5%
Fatigue
5%
Chills
5%
Headache
5%
Dizziness
5%
Lumbar Radiculopathy
5%
Arthralgia
5%
Neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
500mg HTD1801 Bid
1000mg HTD1801 Bid
Placebo Bid

CENTRICITY 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
~200

Find a Location

Who is running the clinical trial?

HighTide Biopharma Pty LtdLead Sponsor
9 Previous Clinical Trials
1,258 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
101 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Adrian Di Bisceglie, MD, FACP, FAASLDStudy DirectorHightide Therapeutics USA, LLC

Media Library

HTD1801 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05623189 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: HTD1801, placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: HTD1801 Highlights & Side Effects. Trial Name: NCT05623189 — Phase 2
HTD1801 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05623189 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05623189 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process of this experiment limited to individuals aged 35 and younger?

"This trial is open to applicants of mature age, ranging between 18 and 75."

Answered by AI

What deleterious effects could HTD1801 have on patient health?

"Although there is some proof of safety, HTD1801 has not yet been tested for efficacy and thus scored a 2 on our team's scale."

Answered by AI

Is there still an opportunity for individuals to join this experiment?

"The most recent data on clinicaltrials.gov confirms that this medical study is actively seeking participants, having been first posted on December 27th 2022 and updated as recently as December 29th."

Answered by AI

What is the maximal capacity of participants in this trial?

"Correct. According to clinicaltrials.gov, recruitment for this trial is ongoing. Starting December 27th 2022 and last updated on the 29th of that month, 210 individuals are needed from 1 medical centre."

Answered by AI

Who has the opportunity to partake in this clinical experiment?

"This clinical trial is recruiting individuals aged 18 to 75 with a medical diagnosis of NASH. To participate, candidates are obliged to fulfil these qualifications: Clinical verification of NASH within 6 months prior to Day 0; Histological evidence demonstrating Fibrosis Stages 2 or 3 according to the Non-alcoholic Steatohepatitis Critical Ranking Number (CRN) Scoring System; A minimum BMI requirement of 25kg/m2 (or 23 kg/m2 for Asian participants); and either an existing Type 2 diabetes Mellitus Diagnosis or Pre-Diabetes status at screening."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Options Health Research
Central Research Institute
Panax Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Haven't been given anything for NASH. Using diet and herbals. I have been diagnosed with this with my GI and am having to do yearly Fibroscans and would like to be able to manage this better.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
2022. "HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05623189.
All > Fatty Liver Disease
~70 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top