A Phase 2 interventional study of Placebo and PF-06835919 Low Dose in Non-alcoholic Fatty Liver Disease, sponsored by Pfizer. Completed at 9 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by Pfizer · Phase 2, Interventional, and Basic science
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Among 16 studies in Non-alcoholic Fatty Liver Disease by Pfizer — none open to participants now, none under way, none of them phase 3. Non-alcoholic Fatty Liver Disease · Pfizer.
Among the 16 studies in Non-alcoholic Fatty Liver Disease by Pfizer, this one is the 7th largest by enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2017, is one of 6 in phase 2, and was the 6th registered.
1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.
Browse Non-alcoholic Fatty Liver Disease studies →None of the 16 studies in Non-alcoholic Fatty Liver Disease by Pfizer is open now. The open studies under Non-alcoholic Fatty Liver Disease, anywhere →
Of the 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 53 is below the median of 60 across 1,177 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Median enrollment 48 across the 15 interventional studies, 120 across the 1 observational. Of the 16 that completed or were terminated, 11 (69%) have results posted.
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Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Non-alcoholic Fatty Liver Disease by Pfizer, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo
75 mg once daily
Drug: PF-06835919 Low Dose
300 mg once daily
Drug: PF-06835919 High Dose
0 mg
75 mg once daily
300 mg once daily
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.
Time frame: Baseline and Week 6
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.
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
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
Time frame: 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
Time frame: 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.
Time frame: Baseline up to Day 56 (Week 8)
| Milestone | Placebo | PF-06835919 75 mg | PF-06835919 300 mg |
|---|---|---|---|
| Started | 19 | 17 | 17 |
| Completed | 17 | 17 | 14 |
| Not completed | 2 | 0 | 3 |
| Withdrew: Adverse event | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 2 |
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.
| Percent Change | Placebo | PF-06835919 75 mg | PF-06835919 300 mg |
|---|---|---|---|
| Percent Change From Baseline in Whole Liver Fat at Week 6 | -7.97 ± 24.521 | 2.84 ± 22.246 | -25.43 ± 22.434 |
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.
| Participants | Placebo | PF-06835919 75 mg | PF-06835919 300 mg |
|---|---|---|---|
| All-causality TEAEs | 5 | 4 | 5 |
| Treatment-related TEAEs | 0 | 1 | 1 |
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
| Participants | Placebo | PF-06835919 75 mg | PF-06835919 300 mg |
|---|---|---|---|
| Sitting DBP (mmHg) Change >= 20 mmHg increase | 1 | 0 | 1 |
| Sitting SBP (mmHg) Change >= 30 mmHg increase | 0 | 0 | 2 |
| Sitting DBP (mmHg) Change >= 20 mmHg decrease | 1 | 1 | 0 |
| Sitting SBP (mmHg) Change >= 30 mmHg decrease | 0 | 1 | 2 |
| Sitting DBP (mmHg) Value <50 mmHg | 0 | 0 | 0 |
| Sitting Pulse Rate (bpm) Value < 40 bpm | 0 | 0 | 0 |
| Sitting Pulse Rate (bpm) Value > 120 bpm | 0 | 0 | 0 |
| Sitting SBP (mmHg) Value < 90 mmHg | 0 | 1 | 0 |
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
| Participants | Placebo | PF-06835919 75 mg | PF-06835919 300 mg |
|---|---|---|---|
| PR Interval (msec) %Change >= 25/50% increase | 0 | 0 | 0 |
| QRS Interval (msec) %Change >= 50% increase | 0 | 0 | 0 |
| QTcF Interval (msec) 30<= Change < 60 increase | 1 | 0 | 0 |
| QTcF Interval (msec) Change >= 60 increase | 0 | 0 | 0 |
| PR Interval (msec) Value >= 300 | 0 | 0 | 0 |
| QRS Interval (msec) Value >= 140 | 0 | 0 | 0 |
| QTcF Interval (msec) 450 <= Value <480 | 1 | 1 | 0 |
| QTcF Interval (msec) 480<= Value < 500 | 0 | 0 | 0 |
| QTcF Interval (msec) Value >= 500 | 1 | 0 | 0 |
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.
| Participants | Placebo | PF-06835919 75 mg | PF-06835919 300 mg |
|---|---|---|---|
| Number of Participants With Laboratory Abnormalities | 9 | 8 | 8 |
Collected over Baseline up to Day 77 (28-35 days post last dose). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/19 (0%) | 0/19 (0%) | 5/19 (26.3%) |
| PF-06835919 75 mg | 0/17 (0%) | 0/17 (0%) | 4/17 (23.5%) |
| PF-06835919 300 mg | 0/17 (0%) | 0/17 (0%) | 5/17 (29.4%) |
| Event | Placebo | PF-06835919 75 mg | PF-06835919 300 mg |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 2/19 | 1/17 | 1/17 |
| DiarrhoeaGastrointestinal disorders | 0/19 | 0/17 | 1/17 |
| DyspepsiaGastrointestinal disorders | 0/19 | 0/17 | 1/17 |
| GastritisGastrointestinal disorders | 0/19 | 0/17 | 1/17 |
| VomitingGastrointestinal disorders | 0/19 | 0/17 | 1/17 |
| FatigueGeneral disorders | 1/19 | 1/17 | 0/17 |
| PainGeneral disorders | 0/19 | 1/17 | 0/17 |
| Viral infectionInfections and infestations | 0/19 | 1/17 | 0/17 |
| Increased appetiteMetabolism and nutrition disorders | 0/19 | 0/17 | 1/17 |
| Back painMusculoskeletal and connective tissue disorders | 1/19 | 0/17 | 1/17 |
The baseline analysis population included all eligible participants who received the study medication.
| Age, Continuous(Years) | Placebo | PF-06835919 75 mg | PF-06835919 300 mg | Total |
|---|---|---|---|---|
| Mean | 51.00 ± 9.67 | 52.82 ± 8.17 | 52.29 ± 9.26 | 52.00 ± 8.94 |
| Age, Customized(Participants) | Placebo | PF-06835919 75 mg | PF-06835919 300 mg | Total |
|---|---|---|---|---|
| 18-44 Years | 6 | 2 | 3 | 11 |
| 45-64 Years | 13 | 15 | 14 | 42 |
| Sex: Female, Male(Participants) | Placebo | PF-06835919 75 mg | PF-06835919 300 mg | Total |
|---|---|---|---|---|
| Female | 7 | 9 | 10 | 26 |
| Male | 12 | 8 | 7 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | PF-06835919 75 mg | PF-06835919 300 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 15 | 6 | 10 | 31 |
| Not Hispanic or Latino | 4 | 11 | 7 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | PF-06835919 75 mg | PF-06835919 300 mg | Total |
|---|---|---|---|---|
| White | 17 | 10 | 12 | 39 |
| Black or African American | 2 | 6 | 5 | 13 |
| Asian | 0 | 1 | 0 | 1 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Age Range(Years) | Placebo | PF-06835919 75 mg | PF-06835919 300 mg | Total |
|---|---|---|---|---|
| Median | 53.00 (31 to 63) | 54.00 (32 to 64) | 54.00 (31 to 63) | 54.00 (31 to 64) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Data sharing details ↗ · www.pfizer.com
Ran from Sep 2017 to primary completion in Mar 2018, 6 months.
Results were first posted in Apr 2019, 1 year after primary completion.
Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 6 months is below that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PF-06835919
Non-alcoholic Fatty Liver Disease →