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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03248882




Registration number
NCT03248882
Ethics application status
Date submitted
10/08/2017
Date registered
14/08/2017

Titles & IDs
Public title
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Scientific title
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-05221304 ADMINISTERED DAILY FOR 16-WEEKS TO ADULT SUBJECTS WITH NONALCOHOLIC FATTY LIVER DISEASE
Secondary ID [1] 0 0
2017-001156-55
Secondary ID [2] 0 0
C1171002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Fatty Liver Disease 0 0
Nonalcoholic Steatohepatitis 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
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - PF-05221304

Placebo comparator: Placebo - Double-Blind, PF-05221304-matching Placebo

Active comparator: PF-05221304 - 2 mg - PF-05221304 - 2 mg, once-daily

Active comparator: PF-05221304 - 10 mg - PF-05221304 - 10 mg, once-daily

Active comparator: PF-05221304 - 25 mg - PF-05221304 - 25 mg, once-daily

Active comparator: PF-05221304 - 50 mg - PF-05221304 - 50 mg, once-daily


Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: PF-05221304
PF-05221304, Experimental Drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
Timepoint [1] 0 0
Baseline (between Day -14 and Day 1), Week 16
Secondary outcome [1] 0 0
Percent Change From Baseline in Alanine Aminotransferase at Week 16
Timepoint [1] 0 0
Baseline (Day 1 pre-dose), Week 16
Secondary outcome [2] 0 0
Number of Participants With Treatment-Emergent Adverse Events
Timepoint [2] 0 0
From first dose of study treatment (Day 1) up to Week 20
Secondary outcome [3] 0 0
Number of Participants With Laboratory Abnormalities
Timepoint [3] 0 0
From first dose of study treatment (Day 1) up to Week 20
Secondary outcome [4] 0 0
Number of Participants With Vital Signs Data Meeting Predefined Criteria
Timepoint [4] 0 0
From first dose of study treatment (Day 1) up to Week 18
Secondary outcome [5] 0 0
Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
Timepoint [5] 0 0
From first dose of study treatment (Day 1) up to Week 18

Eligibility
Key inclusion criteria
* Body Mass Index >= 25 kg/m2
* Body Weight > 50 kg
* Liver fat (assessed via MRI-PDFF) >= 8%
* Biopsy-proven NASH - diagnosed in previous 24-months
* Presumed NASH - per Sponsor's definition
* NAFLD with minimal inflammation/fibrosis
* Features of Metabolic Syndrome
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Alcohol-induced steatohepatitis or other forms of chronic liver disease
* Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
* Severe Renal Impairment
* Contraindications for MRI

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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/03/2019
Sample size
Target
Accrual to date
Final
305
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
Spectrum Medical Imaging - Randwick
Recruitment hospital [3] 0 0
Castlereagh Imaging - Westmead
Recruitment hospital [4] 0 0
Storr Liver Centre, Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Dr. Jones & Partners Medical Imaging - Adelaide
Recruitment hospital [6] 0 0
Royal Adelaide Hospital, Department of Gastroenterology and Hepatology - Adelaide
Recruitment hospital [7] 0 0
Flinders Medical Centre/Department of Gastroenterology & Hepatology - Adelaide
Recruitment hospital [8] 0 0
Radiology SA - Adelaide
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
2013 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Adelaide
Recruitment postcode(s) [6] 0 0
5067 - Adelaide
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
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
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Nova Scotia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Israel
State/province [24] 0 0
Hadera
Country [25] 0 0
Israel
State/province [25] 0 0
Haifa
Country [26] 0 0
Israel
State/province [26] 0 0
Jerusalem
Country [27] 0 0
Israel
State/province [27] 0 0
Nahariya
Country [28] 0 0
Israel
State/province [28] 0 0
Nazareth
Country [29] 0 0
Israel
State/province [29] 0 0
Petah Tikva
Country [30] 0 0
Israel
State/province [30] 0 0
Ramat-Gan
Country [31] 0 0
Israel
State/province [31] 0 0
Tel-Aviv
Country [32] 0 0
Poland
State/province [32] 0 0
Bialystok
Country [33] 0 0
Poland
State/province [33] 0 0
Gdansk
Country [34] 0 0
Poland
State/province [34] 0 0
Gdynia
Country [35] 0 0
Poland
State/province [35] 0 0
Jaworze
Country [36] 0 0
Poland
State/province [36] 0 0
Katowice
Country [37] 0 0
Poland
State/province [37] 0 0
Krakow
Country [38] 0 0
Poland
State/province [38] 0 0
Lodz
Country [39] 0 0
Poland
State/province [39] 0 0
Poznan
Country [40] 0 0
Poland
State/province [40] 0 0
Rzeszow
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Poland
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Warszawa
Country [42] 0 0
Poland
State/province [42] 0 0
Wroclaw
Country [43] 0 0
Taiwan
State/province [43] 0 0
Changhua County
Country [44] 0 0
Taiwan
State/province [44] 0 0
Kaohsiung
Country [45] 0 0
Taiwan
State/province [45] 0 0
Tainan
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03248882