Non-alcoholic SteatohepatitisPhase 1NCT03513588
2-Week Study In People With Nonalcoholic Fatty Liver Disease
A Phase 1 study testing PF-06865571 in people with Non-alcoholic Steatohepatitis and Non-alcoholic Fatty Liver Disease, run by Pfizer at 6 sites in United States.
Trial summary
2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
- What is being tested?
- PF-06865571
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Jun 2018to 4 Apr 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan
- liver fat greater than or equal to 6% via MRI
Who cannot join
- Chronic liver disease
- Type 2 diabetes requiring drug treatment
- Unable to undergo MRI
- History of heart attack or stroke
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
High Point Clinical Trials Center
High Point, North Carolina, 27265
PPD Development, LP
Las Vegas, Nevada, 89113
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Qps-Mra, Llc
South Miami, Florida, 33143
About this study
Official title: A PHASE 1B, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF- 06865571 FOR 2 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.
- Being tested
- Placebo, PF-06865571
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
tablet, 0 mg, 14 days, every 12 hours
PF-06865571Drug
tablet, 50 mg, 14 days, every 12 hours
PF-06865571Drug
tablet, 300 mg, 14 days, every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PF-06865571 100 mg | Experimental | Not described Receives: Drug: PF-06865571 |
| PF-06865571 600 mg | Experimental | Not described Receives: Drug: PF-06865571 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)
MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
Measured: Baseline (Day 1), Day 15
Secondary outcomes (10)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. AEs included both SAEs and non-serious AEs.
Measured: From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days)
Number of Participants With Laboratory Test Abnormalities
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, calcium, chloride, bicarbonate); urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, urine erythrocytes, urine leukocytes, hyaline casts); biomarker (total cholesterol, low-density and high-density lipoprotein cholesterol, triglycerides, fasting glucose). Participants with any of the laboratory test abnormalities were counted.
Measured: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Number of Participants With Vital Sign Abnormalities
Vital sign categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in supine SBP >=30 mmHg.
Measured: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Number of Participants With Electrocardiogram (ECG) Abnormalities
ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (heart rate corrected QT [time between the start of the ECG Q wave and the end of the T wave in the heart's electrical cycle] using Fridericia's formula): absolute value of >450 to 480 msec, >480 to 500 msec, >500 msec; a change from baseline of >30 to 60 msec or >60 msec.
Measured: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Maximum Plasma Concentration (Cmax) For PF-06865571
Cmax of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages.
Measured: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571
AUCtau of PF-06865571 on Day 14 was obtained by linear/log trapezoidal method. The dosing interval (tau) was 12 hours. Geometric coefficients of variations were reported as percentages.
Measured: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571
Tmax of PF-06865571 on Day 14 was observed directly from data as time of Cmax occurrence.
Measured: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Minimum Plasma Concentration (Cmin) For PF-06865571
Cmin of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages.
Measured: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Apparent Oral Clearance (CL/F) For PF-06865571
CL/F of PF-06865571 on Day 14 was calculated as Dose/AUCtau. Geometric coefficients of variations were reported as percentages.
Measured: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Peak-to-Trough Ratio (PTR) For PF-06865571
PTR of PF-06865571 on Day 14 was calculated as Cmax/Cmin. Geometric coefficients of variations were reported as percentages.
Measured: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start21 Jun 2018
- Primary completion8 Mar 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513588
- Sponsor's protocol ID
- C2541005
- Status last verified
- Feb 2020
- First submitted
- 19 Apr 2018
- Last updated
- 13 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.
PubMed 36690550
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1B, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF- 06865571 FOR 2 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
- ClinicalTrials.gov ID
- NCT03513588
- Acronym / sponsor ID
- C2541005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Posted 13 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| PF-06865571 100 mg | Experimental | Drug: PF-06865571 |
| PF-06865571 600 mg | Experimental | Drug: PF-06865571 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan
- liver fat greater than or equal to 6% via MRI
Key exclusion criteria (4 listed)
- Chronic liver disease
- Type 2 diabetes requiring drug treatment
- Unable to undergo MRI
- History of heart attack or stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebotablet, 0 mg, 14 days, every 12 hours | Drug | Placebo |
| PF-06865571tablet, 50 mg, 14 days, every 12 hours | Drug | PF-06865571 100 mg |
| PF-06865571tablet, 300 mg, 14 days, every 12 hours | Drug | PF-06865571 600 mg |
Primary outcome
Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)
Time frame: Baseline (Day 1), Day 15
MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.
10 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days)
Number of Participants With Laboratory Test Abnormalities
Time frame: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Number of Participants With Vital Sign Abnormalities
Time frame: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Maximum Plasma Concentration (Cmax) For PF-06865571
Time frame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571
Time frame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571
Time frame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Minimum Plasma Concentration (Cmin) For PF-06865571
Time frame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Apparent Oral Clearance (CL/F) For PF-06865571
Time frame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Peak-to-Trough Ratio (PTR) For PF-06865571
Time frame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36690550Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06865571 in people with Non-alcoholic Steatohepatitis and Non-alcoholic Fatty Liver Disease, run by Pfizer at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF) (time frame: Baseline (Day 1), Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.