Non-alcoholic Fatty Liver DiseasePhase 2NCT03256526

6-week Safety and PD Study in Adults With NAFLD

A Phase 2 study testing PF-06835919 Low Dose and PF-06835919 High Dose in people with Non-alcoholic Fatty Liver Disease, run by Pfizer at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Non-alcoholic Fatty Liver Disease
What is being tested?: PF-06835919 Low Dose and PF-06835919 High Dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: 9 sitesUnited States
Study dates: 27 Sep 2017to 27 Apr 2018
Phase: Phase 2
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

BMI at least 28 kg/m2
Type 2 diabetes and/or metabolic syndrome

Who cannot join

Liver disease
Type 1 diabetes
Recent heart attack or stroke
Inability to have an MRI scan

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

WR-ClinSearch LLC
Chattanooga, Tennessee, 37421
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219
Avail Clinical Research, LLC
DeLand, Florida, 32720
National Research Institute
Los Angeles, California, 90057
Stand-Up MRI of Miami
Miami, Florida, 33145
Avail Clinical Research, LLC
Orange City, Florida, 32763
National Clinical Research, Inc
Richmond, Virginia, 23294
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Qps-Mra, Llc
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL- GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE

Conditions: Non-alcoholic Fatty Liver Disease
Being tested: Placebo, PF-06835919 Low Dose, PF-06835919 High Dose
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
0 mg
PF-06835919 Low DoseDrug
75 mg once daily
PF-06835919 High DoseDrug
300 mg once daily

Study groups in NCT03256526
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
PF-06835919 Low Dose	Experimental	75 mg once daily Receives: Drug: PF-06835919 Low Dose
PF-06835919 High Dose	Experimental	300 mg once daily Receives: Drug: PF-06835919 High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Whole Liver Fat at Week 6
The percent change from baseline in whole liver fat at Week 6 was assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
MRI-PDFF generates measures of the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF was calculated as follows:
Whole Liver PDFF= PDFFs for (Segment I+Segment II+Segment III+Segment IVa+Segment IVb+Segment V+Segment VI+Segment+VII+Segment VIII) / (number of segments assessed).
The same segments were to be used at both baseline and post-baseline time points in the calculation of whole liver PDFF to derive the percent change from baseline.
The values of whole liver PDFF ranges from 0 to 100 and higher values represent higher liver fat.
Measured: Baseline and Week 6

Secondary outcomes (4)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
All-causality adverse events (AEs) were any untoward medical occurrence in a study participant who administered a product or medical device, the event need not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs were any untoward medical occurrence in a study participant who administered a product or medical device, the event needed to have a causal relationship with the treatment or usage.
A TEAE was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.
Measured: Baseline up to Day 77 (28-35 days post last dose)
Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria
The vital sign categorical criteria included:
Sitting DBP (diastolic blood pressure) millimeter of mercury (mmHg) Change >= 20 mmHg increase Sitting SBP (systolic blood pressure) (mmHg) Change >= 30 mmHg increase Sitting DBP (mmHg) Change >= 20 mmHg decrease Sitting SBP (mmHg) Change >= 30 mmHg decrease Sitting DBP (mmHg) Value < 50 mmHg Sitting Pulse Rate (bpm) Value < 40 bpm or Value > 120 bpm Sitting SBP (mmHg) Value < 90 mmHg
Measured: Baseline up to Day 56 (Week 8)
Number of Participants With Post-dose ECG Data Meeting Categorical Criteria
The ECG categorical criteria included:
PR Interval (msec) percent (%)Change >= 25% increase when baseline >200 or >=50% increase when baseline <=200 QRS Interval (msec) %Change >= 50% increase QTcF Interval (Fridericia's Correction) (msec) increase 30 <= Change < 60 or Change >= 60 PR Interval (msec) Value >= 300 QRS Interval (msec) Value >= 140 QTcF Interval (Fridericia's Correction) (msec) 450 <= Value <480 or 480 <=Value <500 or Value >= 500
Measured: Baseline up to Day 56 (Week 8)
Number of Participants With Laboratory Abnormalities
Below parameters were evaluated for laboratory tests: Hemoglobin, Hematocrit, Erythrocytes, Ery. Mean Copuscular Volume, Ery. Mean Copuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration, Platelets, Leukocytes, Lymphocytes, Neuprophils, Basophils, Eosinophils, Monocytes, Bilirubin, Direct Biliirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Protein, Albumin, Albumin, Blood Urea Nitrogen, Creatinine, Urate, Sodium, Potassium, Chloride, Calcium, Bicarbonate, Glucose-Fasting, pH, Urine Glucose, Ketone, Urine Protein, Urine Hemoglobin, Urobilinogen, Urine Bilirubin, Nitrite, Leukocyte Esterase, Urine Erythocytes, Urine leukocytes, Hyaline Casts, Urine Creatinine.
Measured: Baseline up to Day 56 (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 201727 Apr 2018

First posted22 Aug 2017
Study start27 Sep 2017
Primary completion30 Mar 2018
Study completion27 Apr 2018

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 (2)Papers the sponsor has linked to this study.
Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03256526
Sponsor's protocol ID: C1061003
Status last verified: Mar 2019
First submitted: 16 Aug 2017
Last updated: 4 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Hong JG, Trotman J, Carbajal Y, Dey P, Glass M, Sclar V, Alter IL, Zhang P, Wang L, Chen L, Petitjean M, Bhattacharya D, Wang S, Friedman SL, DeRossi C, Chu J. Mannose reduces fructose metabolism and reverses MASH in human liver slices and murine models in vivo. Hepatol Commun. 2025 Mar 21;9(4):e0671. doi: 10.1097/HC9.0000000000000671. eCollection 2025 Apr 1.
PubMed 40116750
Kazierad DJ, Chidsey K, Somayaji VR, Bergman AJ, Birnbaum MJ, Calle RA. Inhibition of ketohexokinase in adults with NAFLD reduces liver fat and inflammatory markers: A randomized phase 2 trial. Med. 2021 Jul 9;2(7):800-813.e3. doi: 10.1016/j.medj.2021.04.007. Epub 2021 Apr 27.
PubMed 35590219

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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Active, not recruitingPhase 3
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Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)
NASH
Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
RecruitingPhase 3
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Metabolic Dysfunction Associated Steatohepatitis

All Non-alcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL- GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
ClinicalTrials.gov ID: NCT03256526
Acronym / sponsor ID: C1061003
Conditions: Non-alcoholic Fatty Liver Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 27 Sep 2017 (actual)
Primary completion: 30 Mar 2018 (actual)
Study completion: 27 Apr 2018 (actual)
First posted: 22 Aug 2017 (actual)
Results: Posted 4 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
PF-06835919 Low Dose	Experimental	Drug: PF-06835919 Low Dose75 mg once daily
PF-06835919 High Dose	Experimental	Drug: PF-06835919 High Dose300 mg once daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

BMI at least 28 kg/m2
Type 2 diabetes and/or metabolic syndrome

Key exclusion criteria (4 listed)

Liver disease
Type 1 diabetes
Recent heart attack or stroke
Inability to have an MRI scan

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
Placebo0 mg	Drug	Placebo
PF-06835919 Low Dose75 mg once daily	Drug	PF-06835919 Low Dose
PF-06835919 High Dose300 mg once daily	Drug	PF-06835919 High Dose

Primary outcome

Percent Change From Baseline in Whole Liver Fat at Week 6
Time frame: Baseline and Week 6
The percent change from baseline in whole liver fat at Week 6 was assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). MRI-PDFF generates measures of the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF was calculated as follows: Whole Liver PDFF= PDFFs for (Segment I+Segment II+Segment III+Segment IVa+Segment IVb+Segment V+Segment VI+Segment+VII+Segment VIII) / (number of segments assessed). The same segments were to be used at both baseline and post-baseline time points in the calculation of whole liver PDFF to derive the percent change from baseline. The values of whole liver PDFF ranges from 0 to 100 and higher values represent higher liver fat.

4 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 77 (28-35 days post last dose)
Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria
Time frame: Baseline up to Day 56 (Week 8)
Number of Participants With Post-dose ECG Data Meeting Categorical Criteria
Time frame: Baseline up to Day 56 (Week 8)
Number of Participants With Laboratory Abnormalities
Time frame: Baseline up to Day 56 (Week 8)

Results and safety

Results posted to the registry on 4 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	19	17
PF-06835919 75 mg	17	17
PF-06835919 300 mg	17	14

Primary outcome: Percent Change From Baseline in Whole Liver Fat at Week 6

Time frame: Baseline and Week 6. Mean (Standard Deviation). Unit: Percent Change

Measure	Placebo n = 17	PF-06835919 75 mg n = 17	PF-06835919 300 mg n = 13
Value	-7.97 (24.521)	2.84 (22.246)	-25.43 (22.434)

Placebo vs PF-06835919 75 mg: LS mean difference: 11.45 (90% CI -2.19 to 25.09), p = 0.1654, ANCOVA
Placebo vs PF-06835919 300 mg: LS mean difference: -18.73 (90% CI -33.55 to -3.90), p = 0.0395, ANCOVA

Population analysed: The efficacy analysis population was defined as all randomized participants who received at least 1 dose of randomized treatment and assessed by MRI-PDFF at Week 6.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 77 (28-35 days post last dose). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 19 (0%)	5 of 19 (26.3%)	0 of 19
PF-06835919 75 mg	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17
PF-06835919 300 mg	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40116750Hong JG, Trotman J, Carbajal Y, Dey P, Glass M, Sclar V, Alter IL, Zhang P, Wang L, Chen L, Petitjean M, Bhattacharya D, Wang S, Friedman SL, DeRossi C, Chu J. Mannose reduces fructose metabolism and reverses MASH in human liver slices and murine models in vivo. Hepatol Commun. 2025 Mar 21;9(4):e0671. doi: 10.1097/HC9.0000000000000671. eCollection 2025 Apr 1.
Derived from this study: PubMed 35590219Kazierad DJ, Chidsey K, Somayaji VR, Bergman AJ, Birnbaum MJ, Calle RA. Inhibition of ketohexokinase in adults with NAFLD reduces liver fat and inflammatory markers: A randomized phase 2 trial. Med. 2021 Jul 9;2(7):800-813.e3. doi: 10.1016/j.medj.2021.04.007. Epub 2021 Apr 27.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06835919 Low Dose and PF-06835919 High Dose in people with Non-alcoholic Fatty Liver Disease, run by Pfizer at 9 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Apr 2019). 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?

Percent Change From Baseline in Whole Liver Fat at Week 6 (time frame: Baseline and Week 6). 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 NCT03256526, which also lists 2 linked publications.

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 4 Apr 2019.