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A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

NCT ID: NCT03656744

Last Updated: 2021-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2020-03-09

Brief Summary

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Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.

Detailed Description

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This 18-week randomized, double-blind, parallel-group, proof of concept (POC), dose-ranging study compared multiple doses of HTD1801 to placebo in a 1:1:1 ratio. Since accumulation of hepatic fat is considered the "first hit" in the pathogenesis of NASH (Adams and Angulo 2006), change in liver fat content (LFC) by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) is an appropriate primary endpoint and is consistent with that used in other recent Phase 2 POC studies in NASH (Harrison et al., 2018, Madrigal Pharmaceuticals 2018).

The Harrison et al., 2018, Madrigal Pharmaceuticals 2018 study showed clinically meaningful absolute and relative reductions in LFC assessed by MRI-PDFF over 12-week treatment periods thus, it was considered that an 18 week HTD1801 treatment period would therefore be adequate to assess the study's primary endpoint and to maximize collection of exposure and safety related data.

Conditions

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Fatty Liver, Nonalcoholic NAFLD Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Digestive System Diseases Type 2 Diabetes Mellitus (T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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500mg HTD1801, bid

Group Type EXPERIMENTAL

HTD1801

Intervention Type DRUG

HTD1801 tablets, 250mg

1000mg HTD1801, bid

Group Type EXPERIMENTAL

HTD1801

Intervention Type DRUG

HTD1801 tablets, 250mg

placebo, bid

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablets manufactured to mimic HTD1801 tablets

Interventions

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HTD1801

HTD1801 tablets, 250mg

Intervention Type DRUG

Placebo

tablets manufactured to mimic HTD1801 tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of NASH as assessed by MRI
* Clinically documented diagnosis of T2DM
* Body mass index (BMI) \>25 kg/m2

Exclusion Criteria

* Liver disease unrelated to NASH
* Poorly controlled T2DM or Type 1 Diabetes Mellitus
* History of alcohol or substance abuse or dependence
* Inability to undergo MRI for any reason
* History of significant cardiovascular disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HighTide Biopharma Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Di Bisceglie, MD,FACP,FAASLD

Role: STUDY_DIRECTOR

HighTide Therapeutics USA, LLC

Locations

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Institute for Liver Health

Chandler, Arizona, United States

Site Status

Institute for Liver Health

Tucson, Arizona, United States

Site Status

Adobe Clinical Research

Tucson, Arizona, United States

Site Status

National Research Institute

Panorama City, California, United States

Site Status

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Site Status

Florida Research Institute

Lakewood Rch, Florida, United States

Site Status

Compass Research

Orlando, Florida, United States

Site Status

Kansas City Research Institute

Kansas City, Missouri, United States

Site Status

Cumberland Research Associates

Fayetteville, North Carolina, United States

Site Status

Gastro One

Germantown, Tennessee, United States

Site Status

Digestive Health Research

Hermitage, Tennessee, United States

Site Status

Pinnacle Clinical Research

Austin, Texas, United States

Site Status

Doctors Hospital at Renaissance

Edinburg, Texas, United States

Site Status

Pinnacle Clinical Research

San Antonio, Texas, United States

Site Status

Texas Digestive Disease Consultants

Southlake, Texas, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Harrison SA, Gunn N, Neff GW, Kohli A, Liu L, Flyer A, Goldkind L, Di Bisceglie AM. A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes. Nat Commun. 2021 Sep 17;12(1):5503. doi: 10.1038/s41467-021-25701-5.

Reference Type DERIVED
PMID: 34535644 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HTD1801.PCT012

Identifier Type: -

Identifier Source: org_study_id