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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PF-06835919 Low Dose | Experimental | 75 mg once daily |
|
| PF-06835919 High Dose | Experimental | 300 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 0 mg |
| |
| PF-06835919 Low Dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Institute | Los Angeles | California | 90057 | United States | ||
| Avail Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35590219 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to PF-06835919 tablets once daily (QD) were administered orally. |
| FG001 | PF-06835919 75 mg | PF-06835919 75 mg tablets QD were administered orally. |
| FG002 | PF-06835919 300 mg | PF-06835919 300mg tablets QD were administered orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population included all eligible participants who received the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to PF-06835919 tablets once daily (QD) were administered orally. |
| BG001 | PF-06835919 75 mg | PF-06835919 75 mg tablets QD were administered orally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 6 |
|
Baseline up to Day 77 (28-35 days post last dose)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matched to PF-06835919 tablets once daily (QD) were administered orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA v21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 29, 2017 | Mar 12, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2017 | Mar 12, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000730020 | PF-06835919 |
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| Drug |
75 mg once daily |
|
| PF-06835919 High Dose | Drug | 300 mg once daily |
|
| 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 | 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 | 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. | Baseline up to Day 56 (Week 8) |
| DeLand |
| Florida |
| 32720 |
| United States |
| Stand-Up MRI of Miami | Miami | Florida | 33145 | United States |
| Avail Clinical Research, LLC | Orange City | Florida | 32763 | United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | 45219 | United States |
| WR-ClinSearch LLC | Chattanooga | Tennessee | 37421 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | United States |
| BG002 | PF-06835919 300 mg | PF-06835919 300 mg tablets QD were administered orally. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Age Range | Median | Full Range | Years |
|
| OG000 | Placebo | Placebo matched to PF-06835919 tablets once daily (QD) were administered orally. |
| OG001 | PF-06835919 75 mg | PF-06835919 75 mg tablets QD were administered orally. |
| OG002 | PF-06835919 300 mg | PF-06835919 300mg tablets QD were administered orally. |
|
|
|
| Secondary | 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. | The safety analysis population included all participants who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline up to Day 77 (28-35 days post last dose) |
|
|
|
| Secondary | 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 | The analysis population included all participants who received at least 1 dose of investigational product and were evaluated against the criteria. | Posted | Count of Participants | Participants | Baseline up to Day 56 (Week 8) |
|
|
|
| Secondary | 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 | The analysis population included all participants who received at least 1 dose of investigational product and were evaluated against the criteria. | Posted | Count of Participants | Participants | Baseline up to Day 56 (Week 8) |
|
|
|
| Secondary | 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. | The analysis population included participants with at least 1 observation of the given laboratory test while on study treatment. | Posted | Count of Participants | Participants | Baseline up to Day 56 (Week 8) |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 5 |
| 19 |
| EG001 | PF-06835919 75 mg | PF-06835919 75 mg tablets QD were administered orally. | 0 | 17 | 0 | 17 | 4 | 17 |
| EG002 | PF-06835919 300 mg | PF-06835919 300 mg tablets QD were administered orally. | 0 | 17 | 0 | 17 | 5 | 17 |
| Diarrhoea | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
|
Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclosure previously undisclosed confidential information other than study results.
|
|
| 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 |
|
| Sitting Pulse Rate (bpm) Value > 120 bpm |
|
| Sitting SBP (mmHg) Value < 90 mmHg |
|
|
| QTcF Interval (msec) 30<= Change < 60 increase |
|
| QTcF Interval (msec) Change >= 60 increase |
|
| PR Interval (msec) Value >= 300 |
|
| QRS Interval (msec) Value >= 140 |
|
| QTcF Interval (msec) 450 <= Value <480 |
|
| QTcF Interval (msec) 480<= Value < 500 |
|
| QTcF Interval (msec) Value >= 500 |
|