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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04880187




Registration number
NCT04880187
Ethics application status
Date submitted
3/05/2021
Date registered
10/05/2021
Date last updated
8/09/2022

Titles & IDs
Public title
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of AXA1125 in Subjects With Non Cirrhotic, Non Alcoholic Steatohepatitis and Fibrosis (EMMPACT)
Secondary ID [1] 0 0
AXA1125-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Alcoholic Steatohepatitis (NASH) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AXA1125
Treatment: Drugs - Placebo

Experimental: AXA1125 22.6g - 22.6 g AXA1125 administered orally BID with or without food

Experimental: AXA1125 33.9g - 33.9 g AXA1125 administered orally BID with or without food

Placebo comparator: Placebo - Matching Placebo administered orally BID with or without food


Treatment: Drugs: AXA1125
AXA1125 administered BID with or without food

Treatment: Drugs: Placebo
Matching Placebo administered BID with or without food
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in steatohepatitis
Timepoint [1] 0 0
Baseline to Week 48
Secondary outcome [1] 0 0
Resolution of NASH without worsening of fibrosis
Timepoint [1] 0 0
Baseline to week 48
Secondary outcome [2] 0 0
Improvement of fibrosis by one stage without worsening of NASH
Timepoint [2] 0 0
Baseline to week 48
Secondary outcome [3] 0 0
Incidence of study drug emergent adverse events (AEs) and serious adverse events (SAEs)
Timepoint [3] 0 0
Baseline to week 48
Secondary outcome [4] 0 0
Change from baseline in liver stiffness as measured by vibration controlled transient elastography (Fibroscan™)
Timepoint [4] 0 0
Baseline to week 48
Secondary outcome [5] 0 0
Change from baseline in hepatic fat as measured by MRI
Timepoint [5] 0 0
Baseline to week 48
Secondary outcome [6] 0 0
Change from baseline in measures of glucose control as determined by glycated hemoglobin (HbA1c)
Timepoint [6] 0 0
Baseline to week 48

Eligibility
Key inclusion criteria
* Willing to participate in the study and provide written informed consent.
* Male and female adults aged > 18 years.
* Must have NASH and fibrosis on a liver biopsy sample
* If a historical liver biopsy is used for Screening, obtained within 6 months prior to Screening;
* Subjects may have a diagnosis of T2DM
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History or presence of liver disease (other than NAFLD or NASH)
* History or presence of cirrhosis and/or history or presence of hepatic decompensation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
273
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Concord
Recruitment postcode(s) [5] 0 0
- Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
South Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Halifax
Country [20] 0 0
France
State/province [20] 0 0
La Tronche
Country [21] 0 0
France
State/province [21] 0 0
Lyon
Country [22] 0 0
France
State/province [22] 0 0
Montpellier
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Pessac
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Poland
State/province [26] 0 0
CET
Country [27] 0 0
Puerto Rico
State/province [27] 0 0
San Juan
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Axcella Health, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Harrison, MD
Address 0 0
Pinnacle Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Margaret Koziel, MD
Address 0 0
Country 0 0
Phone 0 0
(857) 320-3200
Fax 0 0
Email 0 0
clinicaltrials@axcellahealth.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04880187