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HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes (CENTRICITY)

Primary Purpose

Nonalcoholic Steatohepatitis (NASH), Type 2 Diabetes

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HTD1801
Placebo
Sponsored by
HighTide Biopharma Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion criteria: Clinical diagnosis of non-alcoholic steatohepatitis (NASH) upon central read of a liver biopsy obtained no more than 6 months before Day 0. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the non-alcoholic steatohepatitis (NASH) clinical research network (CRN) scoring of fibrosis. Clinically documented diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening or prediabetes at screening. BMI >25 kilograms/meters squared (>23 kilograms/meters squared if Asian). Key Exclusion criteria: Fibrosis stage 4. History of alcohol or substance abuse or dependence. Liver disease unrelated to non-alcoholic steatohepatitis. History of significant cardiovascular disease. History of type 1 diabetes. Inability or unwillingness to undergo 2 planned liver biopsies OR 1 planned biopsy if historical liver biopsy was used to confirm eligibility at entry.

Sites / Locations

  • Central Research InstituteRecruiting
  • The Institute for Liver Health (Arizona Liver Health)Recruiting
  • Arizona Liver Health - GlendaeRecruiting
  • Adobe Clinical Research LLCRecruiting
  • Aizona Liver HealthRecruiting
  • San Fernando Valley Health InstituteRecruiting
  • GW ResearchRecruiting
  • Clinnova Research SolutionsRecruiting
  • Catalina Research InstituteRecruiting
  • California Liver InstituteRecruiting
  • Inland Empire Liver FoundationRecruiting
  • Excel Medical Clinical Trials, LLCRecruiting
  • Tampa Bay Medical Research, Inc.Recruiting
  • Covenant Metabolic Specialists - Fort MeyersRecruiting
  • Evolution Clinical Trials, Inc.Recruiting
  • ClinCloud LLC MaitlandRecruiting
  • Panax Clinical ResearchRecruiting
  • Floridain Clinical ResearchRecruiting
  • Clinical Pharmacology of Miami, LLCRecruiting
  • Covenant Metabolic Specialists - SarasotaRecruiting
  • Florida Health Sciences Center/Tampa General Hospital/USFRecruiting
  • Theia Clinical Research LLCRecruiting
  • ClinCloud LLC MelbournRecruiting
  • Metabolic Research Institute, Inc.Recruiting
  • Conquest ResearchRecruiting
  • Piedmont Health CareRecruiting
  • Louisvill Metabolic and Atherosclerosis Research Center (L-MARC)Recruiting
  • Tandem Clinical ResearchRecruiting
  • Mercy Medical CenterRecruiting
  • Henry Ford HospitalRecruiting
  • Jubilee Clinical Research, Inc.Recruiting
  • Tandem Clinical Research GI - New YorkRecruiting
  • Lucas Research - Diabetes and EndocrinologyRecruiting
  • Clinical Research Institute of OhioRecruiting
  • Epic Medical ResearchRecruiting
  • Options Health ResearchRecruiting
  • Prisma Health Gastroenterology and Liver CenterRecruiting
  • Palmetto Clinical ResearchRecruiting
  • ClinSearch LLCRecruiting
  • Premier ResearchRecruiting
  • Texas Clinical Research InstituteRecruiting
  • Pinnacle Clinical ResearchRecruiting
  • South Texas Research InstituteRecruiting
  • EPIC Medical ResearchRecruiting
  • Pinnacle Research, Georgetown TXRecruiting
  • Quality Research, Inc.Recruiting
  • Sun Research InstituteRecruiting
  • Pinnacle Clinical Research San AntonioRecruiting
  • Impact Research InstituteRecruiting
  • Manassas Clinical Research CenterRecruiting
  • Liver Institute of VirginiaRecruiting
  • The Liver Institute of VirginiaRecruiting
  • Liver Institute NWRecruiting
  • Humanity and Health Clinical Trial Centre Lt.
  • Chinese University of Hong Kong Prince of Wales Hospital
  • Centro de Investigacion y Gastroenerologias S.C.
  • Physlasis, Clinical Research S. de RL de CV
  • Instituto de Diabetes, Obesidad y Nutricion
  • Fundacion de Investigacion (FDI)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HTD1801

placebo

Arm Description

HTD1801,1250 mg, BID

placebo, BID

Outcomes

Primary Outcome Measures

Primary Endpoint
A decrease of ≥2-points in non-alcoholic fatty liver disease activity score (NAS) with ≥1-point decrease of either lobular inflammation or ballooning and no worsening of fibrosis; OR Resolution of non-alcoholic steatohepatitis (NASH) (defined as the overall histopathologic interpretation of 1) "no fatty liver disease" or 2) "fatty liver disease (simple or isolated steatosis) without steatohepatitis AND a non-alcoholic fatty liver disease activity score (NAS) of 0 for ballooning and 0-1 for inflammation and no worsening of fibrosis. Nonalcoholic fatty liver disease activity score (NAS) is a histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2). The higher the score the more severe the disease. The total range for non-alcoholic fatty liver disease activity score (NAS) is between 0 to 8. The lower the score the better the outcome.

Secondary Outcome Measures

Endpoint 1
Percentage of subjects with resolution of non-alcoholic steatohepatitis (NASH) on overall histopathological reading
Endpoint 2
Percentage of subjects with resolution of non-alcoholic steatohepatitis hepatitis (NASH) and at least a 2-point improvement in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) and no worsening of liver fibrosis
Endpoint 3
Percentage of subjects with a ≥1-stage improvement in liver fibrosis.
Endpoint 4
Percentage of subjects with a ≥1-stage improvement in liver fibrosis and no worsening of non-alcoholic steatohepatitis (NASH).
Endpoint 5
Percentage of subjects with a ≥2-stage improvement in liver fibrosis.
Endpoint 6
Percentage of subjects with a ≥2-point improvement in non-alcoholic fatty liver disease activity score (NAS) and no worsening of liver fibrosis.
Endpoint 7
Percentage of subjects with an improvement in each of the individual non-alcoholic fatty liver disease activity score (NAS) components (ballooning, inflammation, or steatosis).
Endpoint 8
Percentage of subjects with improvement of non-alcoholic steatohepatitis (NASH) based on overall histopathologic interpretation.
Endpoint 9
Absolute and percent change in alanine aminotransferase (ALT) from baseline to end of treatment.
Endpoint 10
Absolute and percent change in aspartate aminotransferase (AST) from baseline to end of treatment.
Endpoint 11
Absolute and percent change in gamma-glutamyl transferase (GGT) from baseline to end of treatment.
Endpoint 12
Absolute and percent change in total bilirubin from baseline to end of treatment.
Endpoint 13
Absolute and percent change in direct bilirubin from baseline to end of treatment.
Endpoint 14
Absolute and percent change in hemoglobin A1c (HbA1c) from baseline to end of treatment.
Endpoint 15
Absolute and percent change in fasting plasma glucose from baseline to end of treatment.
Endpoint 16
Absolute and percent change in body weight from baseline to end of treatment.
Endpoint 17
Absolute and percent change in body mass index (BMI) from baseline to end of treatment.
Endpoint 18
Absolute and percent change in hip circumference from baseline to end of treatment.
Endpoint 19
Absolute and percent change in waist circumference from baseline to end of treatment.
Endpoint 20
Absolute and percent change in total cholesterol from baseline to end of treatment.
Endpoint 21
Absolute and percent change in low-density lipoprotein cholesterol (LDL-c) from baseline to end of treatment.
Endpoint 22
Absolute and percent change in lipoprotein A (Lpa) from baseline to end of treatment.
Endpoint 23
Absolute and percent change in high-density lipoprotein cholesterol (HDL-c) from baseline to end of treatment.
Endpoint 24
Absolute and percent change in triglycerides from baseline to end of treatment.
Endpoint 25
Absolute and percent change in apolipoprotein B (ApoB) from baseline to end of treatment.
Endpoint 26
Absolute and percent change in liver stiffness as measured by vibration-controlled transient elastography (VCTE) using FibroScan® device from baseline to end of treatment. The VCTE score is measured in Kilopascal Pressure Unit (kPa) and ranges from 2 to 75 kPa. The higher the kPa score the more severe the liver stiffness.
Endpoint 27
Absolute and percent change in liver fat content as measured by controlled attenuation parameter (CAP) using FibroScan® device from baseline to end of treatment. The controlled attenuation parameter (CAP) score is measured in decibels per meter (dB/m) it ranges from 100 to 400 dB/m. The higher the controlled attenuation parameter (CAP) score the more severe the steatosis.
Endpoint 28
Absolute and percent change in the FibroScan-AST (FAST) score from baseline to end of treatment. Fast score will be calculated based on LSM, CAP and AST values using FAST equation. An equal to or more than 0.35 value thru equal or less than 0.81 value is positive predictive value for nonalcoholic steatohepatitis and a negative predictive value from 0.73 to 1.0.

Full Information

First Posted
October 11, 2022
Last Updated
September 7, 2023
Sponsor
HighTide Biopharma Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05623189
Brief Title
HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
Acronym
CENTRICITY
Official Title
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of HTD1801 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis Who Have Type 2 Diabetes (T2DM) or Pre-Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HighTide Biopharma Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.
Detailed Description
This phase 2b, double-blind, randomized, placebo-controlled, multicenter study will evaluate the effect of HTD1801, 1250 mg twice daily (BID) compared to placebo BID on histologic improvements in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes. The study will enroll approximately 210 subjects with biopsy-confirmed non-alcoholic steatohepatitis and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive investigational product for up to 60 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH), Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
This phase 2b, double-blind, placebo-controlled, multicenter study will evaluate the effect of HTD1801 on histologic improvements in adult subjects with non-alcoholic steatohepatitis (NASH) and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes. Approximately 210 subjects with biopsy-confirmed NASH and evidence of stage 2 or stage 3 liver fibrosis will be randomized 2:1 to receive HTD1801 1250 mg twice daily (BID) or placebo BID. Subjects will receive investigational product for up to 60 weeks.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HTD1801
Arm Type
Experimental
Arm Description
HTD1801,1250 mg, BID
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo, BID
Intervention Type
Drug
Intervention Name(s)
HTD1801
Other Intervention Name(s)
HTD1801 capsules
Intervention Description
HTD1801,1250 mg, BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo capsules
Intervention Description
Placebo, BID
Primary Outcome Measure Information:
Title
Primary Endpoint
Description
A decrease of ≥2-points in non-alcoholic fatty liver disease activity score (NAS) with ≥1-point decrease of either lobular inflammation or ballooning and no worsening of fibrosis; OR Resolution of non-alcoholic steatohepatitis (NASH) (defined as the overall histopathologic interpretation of 1) "no fatty liver disease" or 2) "fatty liver disease (simple or isolated steatosis) without steatohepatitis AND a non-alcoholic fatty liver disease activity score (NAS) of 0 for ballooning and 0-1 for inflammation and no worsening of fibrosis. Nonalcoholic fatty liver disease activity score (NAS) is a histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2). The higher the score the more severe the disease. The total range for non-alcoholic fatty liver disease activity score (NAS) is between 0 to 8. The lower the score the better the outcome.
Time Frame
Up to 60 Weeks
Secondary Outcome Measure Information:
Title
Endpoint 1
Description
Percentage of subjects with resolution of non-alcoholic steatohepatitis (NASH) on overall histopathological reading
Time Frame
Up to 60 Weeks
Title
Endpoint 2
Description
Percentage of subjects with resolution of non-alcoholic steatohepatitis hepatitis (NASH) and at least a 2-point improvement in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) and no worsening of liver fibrosis
Time Frame
Up to 60 Weeks
Title
Endpoint 3
Description
Percentage of subjects with a ≥1-stage improvement in liver fibrosis.
Time Frame
Up to 60 Weeks
Title
Endpoint 4
Description
Percentage of subjects with a ≥1-stage improvement in liver fibrosis and no worsening of non-alcoholic steatohepatitis (NASH).
Time Frame
Up to 60 Weeks
Title
Endpoint 5
Description
Percentage of subjects with a ≥2-stage improvement in liver fibrosis.
Time Frame
Up to 60 Weeks
Title
Endpoint 6
Description
Percentage of subjects with a ≥2-point improvement in non-alcoholic fatty liver disease activity score (NAS) and no worsening of liver fibrosis.
Time Frame
Up to 60 Weeks
Title
Endpoint 7
Description
Percentage of subjects with an improvement in each of the individual non-alcoholic fatty liver disease activity score (NAS) components (ballooning, inflammation, or steatosis).
Time Frame
Up to 60 Weeks
Title
Endpoint 8
Description
Percentage of subjects with improvement of non-alcoholic steatohepatitis (NASH) based on overall histopathologic interpretation.
Time Frame
Up to 60 Weeks
Title
Endpoint 9
Description
Absolute and percent change in alanine aminotransferase (ALT) from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 10
Description
Absolute and percent change in aspartate aminotransferase (AST) from baseline to end of treatment.
Time Frame
Up to 60 Weeks.
Title
Endpoint 11
Description
Absolute and percent change in gamma-glutamyl transferase (GGT) from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 12
Description
Absolute and percent change in total bilirubin from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 13
Description
Absolute and percent change in direct bilirubin from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 14
Description
Absolute and percent change in hemoglobin A1c (HbA1c) from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 15
Description
Absolute and percent change in fasting plasma glucose from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 16
Description
Absolute and percent change in body weight from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 17
Description
Absolute and percent change in body mass index (BMI) from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 18
Description
Absolute and percent change in hip circumference from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 19
Description
Absolute and percent change in waist circumference from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 20
Description
Absolute and percent change in total cholesterol from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 21
Description
Absolute and percent change in low-density lipoprotein cholesterol (LDL-c) from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 22
Description
Absolute and percent change in lipoprotein A (Lpa) from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 23
Description
Absolute and percent change in high-density lipoprotein cholesterol (HDL-c) from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 24
Description
Absolute and percent change in triglycerides from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 25
Description
Absolute and percent change in apolipoprotein B (ApoB) from baseline to end of treatment.
Time Frame
Up to 60 Weeks
Title
Endpoint 26
Description
Absolute and percent change in liver stiffness as measured by vibration-controlled transient elastography (VCTE) using FibroScan® device from baseline to end of treatment. The VCTE score is measured in Kilopascal Pressure Unit (kPa) and ranges from 2 to 75 kPa. The higher the kPa score the more severe the liver stiffness.
Time Frame
Up to 60 Weeks
Title
Endpoint 27
Description
Absolute and percent change in liver fat content as measured by controlled attenuation parameter (CAP) using FibroScan® device from baseline to end of treatment. The controlled attenuation parameter (CAP) score is measured in decibels per meter (dB/m) it ranges from 100 to 400 dB/m. The higher the controlled attenuation parameter (CAP) score the more severe the steatosis.
Time Frame
Up to 60 Weeks
Title
Endpoint 28
Description
Absolute and percent change in the FibroScan-AST (FAST) score from baseline to end of treatment. Fast score will be calculated based on LSM, CAP and AST values using FAST equation. An equal to or more than 0.35 value thru equal or less than 0.81 value is positive predictive value for nonalcoholic steatohepatitis and a negative predictive value from 0.73 to 1.0.
Time Frame
Up to 60 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion criteria: Clinical diagnosis of non-alcoholic steatohepatitis (NASH) upon central read of a liver biopsy obtained no more than 6 months before Day 0. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the non-alcoholic steatohepatitis (NASH) clinical research network (CRN) scoring of fibrosis. Clinically documented diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening or prediabetes at screening. BMI >25 kilograms/meters squared (>23 kilograms/meters squared if Asian). Key Exclusion criteria: Fibrosis stage 4. History of alcohol or substance abuse or dependence. Liver disease unrelated to non-alcoholic steatohepatitis. History of significant cardiovascular disease. History of type 1 diabetes. Inability or unwillingness to undergo 2 planned liver biopsies OR 1 planned biopsy if historical liver biopsy was used to confirm eligibility at entry.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathryn Bennett, BN, RN, CCRA
Phone
1-760-809-3523
Email
cbennett@hightidetx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Di Bisceglie, MD, FACP, FAASLD
Organizational Affiliation
Hightide Therapeutics USA, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Institute
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
The Institute for Liver Health (Arizona Liver Health)
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Liver Health - Glendae
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Name
Adobe Clinical Research LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
Aizona Liver Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
San Fernando Valley Health Institute
City
Canoga Park
State/Province
California
ZIP/Postal Code
91302
Country
United States
Individual Site Status
Recruiting
Facility Name
GW Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinnova Research Solutions
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Recruiting
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Name
California Liver Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Name
Excel Medical Clinical Trials, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa Bay Medical Research, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Name
Covenant Metabolic Specialists - Fort Meyers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Name
Evolution Clinical Trials, Inc.
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinCloud LLC Maitland
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Floridain Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Pharmacology of Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Covenant Metabolic Specialists - Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Health Sciences Center/Tampa General Hospital/USF
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Theia Clinical Research LLC
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinCloud LLC Melbourn
City
Viera
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Individual Site Status
Recruiting
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Health Care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisvill Metabolic and Atherosclerosis Research Center (L-MARC)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Jubilee Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research GI - New York
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Individual Site Status
Recruiting
Facility Name
Lucas Research - Diabetes and Endocrinology
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute of Ohio
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Individual Site Status
Recruiting
Facility Name
Epic Medical Research
City
Chickasha
State/Province
Oklahoma
ZIP/Postal Code
73108
Country
United States
Individual Site Status
Recruiting
Facility Name
Options Health Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74194
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health Gastroenterology and Liver Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Individual Site Status
Recruiting
Facility Name
ClinSearch LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Research
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Name
South Texas Research Institute
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Recruiting
Facility Name
EPIC Medical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Research, Georgetown TX
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Quality Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Individual Site Status
Recruiting
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Clinical Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Impact Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadege Gunn, MD
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Individual Site Status
Recruiting
Facility Name
Liver Institute of Virginia
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Individual Site Status
Recruiting
Facility Name
The Liver Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23223
Country
United States
Individual Site Status
Recruiting
Facility Name
Liver Institute NW
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
Humanity and Health Clinical Trial Centre Lt.
City
Hong Kong
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Name
Chinese University of Hong Kong Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Name
Centro de Investigacion y Gastroenerologias S.C.
City
Cuauhtémoc
State/Province
Cuidad De Mexico
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Physlasis, Clinical Research S. de RL de CV
City
Cuautitlán Izcalli
ZIP/Postal Code
54769
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Instituto de Diabetes, Obesidad y Nutricion
City
Cuernavaca
ZIP/Postal Code
66250
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Fundacion de Investigacion (FDI)
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes

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