A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM
1 other identifier
interventional
101
1 country
17
Brief Summary
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2018
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
September 4, 2018
CompletedStudy Start
First participant enrolled
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2020
CompletedResults Posted
Study results publicly available
December 29, 2021
CompletedDecember 29, 2021
November 1, 2021
1.2 years
August 30, 2018
May 12, 2021
November 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change in Liver Fat Content (LFC) as Measured by MRI-PDFF
The primary endpoint was the absolute change in liver fat content (LFC) as measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) from Baseline to Week 18.
Baseline through study Week 18
Secondary Outcomes (21)
Change in Fasting Glucose
Baseline through study Week 18
Changes in Hemoglobin A1c
Baseline through study week 18
Proportion of Subjects Who Achieved ≥ 30% Relative Reduction in LFC as Measured by MRI-PDFF
Baseline through study week 18
Relative Change in LFC as Measured by MRI-PDFF
Baseline through study week 18
Number of Subjects Who Normalized LFC to <5% as Measured by MRI-PDFF
Baseline through study Week 18
- +16 more secondary outcomes
Study Arms (3)
500mg HTD1801, bid
EXPERIMENTAL1000mg HTD1801, bid
EXPERIMENTALplacebo, bid
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of NASH as assessed by MRI
- Clinically documented diagnosis of T2DM
- Body mass index (BMI) \>25 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Institute for Liver Health
Chandler, Arizona, 85224, United States
Institute for Liver Health
Tucson, Arizona, 85711, United States
Adobe Clinical Research
Tucson, Arizona, 85712, United States
National Research Institute
Panorama City, California, 91402, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Compass Research
Orlando, Florida, 32806, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304, United States
Gastro One
Germantown, Tennessee, 38138, United States
Digestive Health Research
Hermitage, Tennessee, 37076, United States
Pinnacle Clinical Research
Austin, Texas, 78746, United States
Doctors Hospital at Renaissance
Edinburg, Texas, 78539, United States
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Harborview Medical Center
Seattle, Washington, 98195, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 34535644DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was conducted exclusively in the United States and data may not be applicable to other populations. The study enrolled subjects with presumed NASH and diabetes. Further studies to determine the effect of HTD1801 in non-diabetics may be needed. Future studies will focus on patients with biopsy confirmed NASH and use liver histology (i.e., liver biopsies) as a histological endpoint.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- HighTide Therapeutics
Study Officials
- STUDY DIRECTOR
Adrian Di Bisceglie, MD,FACP,FAASLD
HighTide Therapeutics USA, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2018
First Posted
September 4, 2018
Study Start
November 26, 2018
Primary Completion
February 7, 2020
Study Completion
March 9, 2020
Last Updated
December 29, 2021
Results First Posted
December 29, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share