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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03248882




Registration number
NCT03248882
Ethics application status
Date submitted
10/08/2017
Date registered
14/08/2017
Date last updated
9/12/2020

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
Country [15] 0 0
United States of America
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Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
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
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Poland
State/province [36] 0 0
Katowice
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Poland
State/province [37] 0 0
Krakow
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Poland
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Lodz
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Poland
State/province [39] 0 0
Poznan
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Poland
State/province [40] 0 0
Rzeszow
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Poland
State/province [41] 0 0
Warszawa
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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
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Trial website
https://clinicaltrials.gov/ct2/show/NCT03248882
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03248882