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The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides. The study has a 2-part design with sequential conduct of Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned to be identical, however, data from Part 1 will be used to determine whether to conduct Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive medication for 6 weeks |
|
| DGAT2i (25 mg BID) + ACCi (10 mg BID) | Experimental | Participants will receive medication for 6 weeks |
|
| DGAT2i (100 mg BID) + ACCi (10 mg BID) | Experimental | Participants will receive medication for 6 weeks |
|
| DGAT2i (300 mg QD) + ACCi (20 mg QD) | Experimental | Participants will receive medication for 6 weeks |
|
| DGAT2i (300 mg BID) + ACCi (10 mg BID) | Experimental | Participants will receive medication for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06865571 | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline (CFB) in Percent (%) Liver Fat as Assessed Via Magnetic Resonance Imaging Using Proton Density Fat Fraction Acquisition (MRI-PDFF) at Week 6 | MRI-PDFF technique is an established method that enables quantification of fat content in the liver. It measures 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 = the sum of PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by (number of segments assessed and no missing/mapping at Baseline, and on Week 6). If some segments did not have results reported at Baseline and/or Week 6, liver PDFF was to be calculated using data in segments that had data available at both Baseline visit and Week 6 visit. For this outcome measure (OM), baseline is defined as the assessment undertaken between Visit 3/Week -2 and Visit 4/Day 1. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent CFB in Fasting Serum Triglycerides at Week 6 | Blood samples were collected before morning dose for the measurement of fasting serum triglycerides. Natural log transformed relative changes from baseline in fasting serum triglycerides were analyzed using mixed model repeated measures (MMRM) analysis with treatment, week and treatment by-week interaction as fixed effects, participant as random effect and log transformed baseline as a covariate using unstructured covariance structure. Values were back-transformed from the log scale. Relative change was converted to percent change as follows: Percent change = 100*(RC-1). For this OM, baseline is defined as the result closest prior to dosing on Day 1 (either predose on Day 1/Visit 4 or Week -2/Visit 3). |
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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 |
|---|---|---|---|---|---|---|
| Clinical Trials Research | Lincoln | California | 95648 | United States | ||
| Catalina Research Institute, LLC |
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| 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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In Part 1, 76 participants were enrolled and 75 were randomized (including 1 participant who was randomized 2 times at the same site), and 74 unique participants received at least 1 dose of study intervention. A decision was made that Part 2 would not proceed based on Part 1 interim analysis, therefore enrollment for Part 2 was not conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (placebo tablets matching the diacylglycerol acyltransferase 2 inhibitor [DGAT2i] PF-06865571) plus 1 small tablet (placebo tablet matching the acetyl-CoA carboxylase inhibitor [ACCi] PF-05221304). Two follow-up visits were scheduled after end of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Treatment |
|
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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 | Mar 27, 2020 | Mar 20, 2023 |
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Dose-ranging of combination doses
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Double-blind, Double-dummy, Placebo controlled
|
| PF-05221304 | Drug | Tablet |
|
|
| Placebo | Drug | Tablet |
|
| Baseline, Week 6 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=all AEs included in the AE Case Report Form (CRF) page during the study. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; or resulted in congenital anomaly/birth defect. Severe TEAEs were defined as AEs that prevent normal everyday activities. Treatment-related TEAEs were determined by the investigator. | Baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks). |
| Number of Participants With TEAEs of Special Interest by Preferred Term (PT) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=all AEs included in the AE CRF page during the study. A 3-tier approach was used to summarize and classify TEAEs into 1 of 3 tiers by the investigator based on their incidence rate and clinical importance to the trial. Tier-1 events = pre-specified events of clinical importance that are maintained in a program level list. Tier-2 events = events that are not tier-1 but are "common". A Medical Dictionary for Regulatory Activities Terminology (MedDRA) PT is defined as a tier-2 event if there are at least 4 participants with at least one occurrence in any treatment group, to distinguish Tier-2 events from Tier-3 events. Tier-3 events = events that do not meet criteria for either tier-1 or tier-2 event. TEAE(s) of special interest reported in at least 1 participant are presented in this OM. | Baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks). |
| Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality | Participants with laboratory test abnormalities (hematology, chemistry and urinalysis) meeting pre-specified criteria are reported without regard to baseline abnormality. LLN is lower limit of normal. ULN is upper limit of normal. Baseline was defined as the result closest prior to Day 1 dosing. | From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks) |
| Number of Participants With Abnormalities in Laboratory Parameters of Special Interest Meeting Pre-Defined Criteria | Laboratory parameters of special interest included fasting serum triglycerides, platelet count, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, direct bilirubin, and fasting plasma glucose. Pre-specified criteria for laboratory parameters of special interest included flag level threshold (reflecting either the threshold for study entry or clinical significance) and alert level threshold (requiring rapid notification to site and study team when values exceeding the threshold were noted during the study). All flag level changes and alert level changes were cumulative from baseline (defined as result closest prior to dosing at Day 1). LLN is lower limit of normal. ULN is upper limit of normal. | From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks) |
| Number of Participants With Post-Baseline Vital Signs Data Meeting Pre-Defined Criteria | Pre-defined categorical criteria for vital signs data of special clinical concern included: seated systolic blood pressure (BP) absolute value <90 mmHg or change from baseline >=30 mmHg, seated diastolic BP absolute value <50 mmHg or change from baseline >=20 mmHg, seated pulse rate absolute value <40 beats per minute (bpm) or >120 bpm. Baseline was defined as the result closest prior to Day 1 dosing. | Baseline, Week 6, the first follow-up visit (Week 8), and the date of discontinuation/withdrawal from study (maximum of approximately 12 weeks after Day 1) if applicable |
| Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Pre-Defined Criteria | Pre-defined categorical criteria for ECG data of special clinical concern included: (1) QTc interval absolute value >450 and <=480 msec (mild prolongation), >480 and <=500 msec (moderate prolongation), >500 msec (severe prolongation); (2) QTc interval increase from baseline >=30 and <=60 msec (moderate prolongation), or >60 msec (severe prolongation); (3) uncorrected QT interval >500 msec. ECG abnormalities meeting prespecified criteria and reported in at least 1 participant are presented in this OM. Baseline was defined as the result closest prior to Day 1 dosing. | Baseline, Week 6, the first follow-up visit (Week 8), and the date of discontinuation/withdrawal from study (maximum of approximately 12 weeks after Day 1) if applicable |
| Montclair |
| California |
| 91763 |
| United States |
| Excel Medical Clinical Trials | Boca Raton | Florida | 33434 | United States |
| Optimus U Corporation | Miami | Florida | 33125 | United States |
| Floridian Clinical Research, LLC | Miami Lakes | Florida | 33016 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | 45246 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| National Clinical Research, Inc. | Richmond | Virginia | 23294 | United States |
| Nova Scotia Health Authority QE II Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Nova Scotia Health Authority QE II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3K 4N1 | Canada |
| Aggarwal and Associates Limited | Brampton | Ontario | L6T 0G1 | Canada |
| Milestone Research Inc. | London | Ontario | N5W 6A2 | Canada |
| Resonance Magnetique du Saguenay-Lac-Saint-Jean | Chicoutimi | Quebec | G7H 4J1 | Canada |
| Ecogene-21 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Alpha Recherche Clinique | Québec | Quebec | G2J 0C4 | Canada |
| Centre de Recherche Saint-Louis | Québec | G1W 4R4 | Canada |
| FG001 | PF-06865571 25 mg Twice Daily (BID) + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (1 DGAT2i-matching placebo tablet, 1 DGAT2i 25 mg tablet) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| FG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. Two follow-up visits were scheduled after end of treatment. |
| FG003 | PF-06865571 300 mg Once Daily (QD) + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| FG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-Up |
|
|
Baseline population included all participants who were randomized and received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (placebo tablets matching the diacylglycerol acyltransferase 2 inhibitor [DGAT2i] PF-06865571) plus 1 small tablet (placebo tablet matching the acetyl-CoA carboxylase inhibitor [ACCi] PF-05221304). Two follow-up visits were scheduled after end of treatment. |
| BG001 | PF-06865571 25 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (1 DGAT2i-matching placebo tablet, 1 DGAT2i 25 mg tablet) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| BG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| BG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| BG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 (CFB) in Percent (%) Liver Fat as Assessed Via Magnetic Resonance Imaging Using Proton Density Fat Fraction Acquisition (MRI-PDFF) at Week 6 | MRI-PDFF technique is an established method that enables quantification of fat content in the liver. It measures 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 = the sum of PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by (number of segments assessed and no missing/mapping at Baseline, and on Week 6). If some segments did not have results reported at Baseline and/or Week 6, liver PDFF was to be calculated using data in segments that had data available at both Baseline visit and Week 6 visit. For this outcome measure (OM), baseline is defined as the assessment undertaken between Visit 3/Week -2 and Visit 4/Day 1. | The analysis population included all participants randomized who received at least 1 dose of study intervention (Placebo/DGAT2i + ACCi), and had at least 1 observation in the model used for this OM. | Posted | Least Squares Mean | 80% Confidence Interval | Percent change | Baseline, Week 6 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent CFB in Fasting Serum Triglycerides at Week 6 | Blood samples were collected before morning dose for the measurement of fasting serum triglycerides. Natural log transformed relative changes from baseline in fasting serum triglycerides were analyzed using mixed model repeated measures (MMRM) analysis with treatment, week and treatment by-week interaction as fixed effects, participant as random effect and log transformed baseline as a covariate using unstructured covariance structure. Values were back-transformed from the log scale. Relative change was converted to percent change as follows: Percent change = 100*(RC-1). For this OM, baseline is defined as the result closest prior to dosing on Day 1 (either predose on Day 1/Visit 4 or Week -2/Visit 3). | The analysis population included all participants randomized who received at least 1 dose of study intervention (Placebo/DGAT2i + ACCi), and had at least 1 observation in the model used for this OM. | Posted | Least Squares Mean | 80% Confidence Interval | Percent change | Baseline, Week 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=all AEs included in the AE Case Report Form (CRF) page during the study. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; or resulted in congenital anomaly/birth defect. Severe TEAEs were defined as AEs that prevent normal everyday activities. Treatment-related TEAEs were determined by the investigator. | The analysis population included all participants who were randomized to study intervention. | Posted | Count of Participants | Participants | Baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks). |
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| Secondary | Number of Participants With TEAEs of Special Interest by Preferred Term (PT) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=all AEs included in the AE CRF page during the study. A 3-tier approach was used to summarize and classify TEAEs into 1 of 3 tiers by the investigator based on their incidence rate and clinical importance to the trial. Tier-1 events = pre-specified events of clinical importance that are maintained in a program level list. Tier-2 events = events that are not tier-1 but are "common". A Medical Dictionary for Regulatory Activities Terminology (MedDRA) PT is defined as a tier-2 event if there are at least 4 participants with at least one occurrence in any treatment group, to distinguish Tier-2 events from Tier-3 events. Tier-3 events = events that do not meet criteria for either tier-1 or tier-2 event. TEAE(s) of special interest reported in at least 1 participant are presented in this OM. | The analysis population included all participants who were randomized to study intervention. | Posted | Count of Participants | Participants | Baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality | Participants with laboratory test abnormalities (hematology, chemistry and urinalysis) meeting pre-specified criteria are reported without regard to baseline abnormality. LLN is lower limit of normal. ULN is upper limit of normal. Baseline was defined as the result closest prior to Day 1 dosing. | The analysis population included all participants who were randomized and received at least 1 dose of study intervention. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = number of participants evaluable for each category. | Posted | Count of Participants | Participants | From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Laboratory Parameters of Special Interest Meeting Pre-Defined Criteria | Laboratory parameters of special interest included fasting serum triglycerides, platelet count, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, direct bilirubin, and fasting plasma glucose. Pre-specified criteria for laboratory parameters of special interest included flag level threshold (reflecting either the threshold for study entry or clinical significance) and alert level threshold (requiring rapid notification to site and study team when values exceeding the threshold were noted during the study). All flag level changes and alert level changes were cumulative from baseline (defined as result closest prior to dosing at Day 1). LLN is lower limit of normal. ULN is upper limit of normal. | The analysis population included all participants who were randomized and received at least 1 dose of study intervention. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = number of participants evaluable for each category. | Posted | Count of Participants | Participants | From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Post-Baseline Vital Signs Data Meeting Pre-Defined Criteria | Pre-defined categorical criteria for vital signs data of special clinical concern included: seated systolic blood pressure (BP) absolute value <90 mmHg or change from baseline >=30 mmHg, seated diastolic BP absolute value <50 mmHg or change from baseline >=20 mmHg, seated pulse rate absolute value <40 beats per minute (bpm) or >120 bpm. Baseline was defined as the result closest prior to Day 1 dosing. | The analysis population included all participants randomized who received at least 1 dose of study intervention and were evaluable for vital signs. | Posted | Count of Participants | Participants | Baseline, Week 6, the first follow-up visit (Week 8), and the date of discontinuation/withdrawal from study (maximum of approximately 12 weeks after Day 1) if applicable |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Pre-Defined Criteria | Pre-defined categorical criteria for ECG data of special clinical concern included: (1) QTc interval absolute value >450 and <=480 msec (mild prolongation), >480 and <=500 msec (moderate prolongation), >500 msec (severe prolongation); (2) QTc interval increase from baseline >=30 and <=60 msec (moderate prolongation), or >60 msec (severe prolongation); (3) uncorrected QT interval >500 msec. ECG abnormalities meeting prespecified criteria and reported in at least 1 participant are presented in this OM. Baseline was defined as the result closest prior to Day 1 dosing. | The analysis population included all participants randomized who received at least 1 dose of study intervention and were evaluable for ECG. | Posted | Count of Participants | Participants | Baseline, Week 6, the first follow-up visit (Week 8), and the date of discontinuation/withdrawal from study (maximum of approximately 12 weeks after Day 1) if applicable |
|
Baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks).
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (placebo tablets matching the diacylglycerol acyltransferase 2 inhibitor [DGAT2i] PF-06865571) plus 1 small tablet (placebo tablet matching the acetyl-CoA carboxylase inhibitor [ACCi] PF-05221304). Two follow-up visits were scheduled after end of treatment. | 0 | 15 | 0 | 15 | 2 | 15 |
| EG001 | PF-06865571 25 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (1 DGAT2i-matching placebo tablet, 1 DGAT2i 25 mg tablet) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. Two follow-up visits were scheduled after end of treatment. | 0 | 15 | 0 | 15 | 4 | 15 |
| EG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. | 0 | 13 | 0 | 13 | 5 | 13 |
| EG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. | 0 | 18 | 0 | 18 | 6 | 18 |
| EG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. | 0 | 14 | 0 | 14 | 7 | 14 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cytokeratin 18 increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 antibody test positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Crystalluria | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
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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 disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2021 | Mar 20, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000726790 | ervogastat |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| 45-64 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. |
| ANCOVA |
| <0.0001 |
| Difference in LS mean |
| -56.58 |
| 80 |
| -63.88 |
| -47.80 |
| Superiority |
| Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. Relative change was converted to percent change as follows: Percent change = 100*(RC-1). 80% CI was calculated based on difference in LS mean between groups. | ANCOVA | <0.0001 | Difference in LS mean | -58.80 | 80 | -65.66 | -50.57 | Superiority |
| Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. | ANCOVA | 0.0003 | Difference in LS mean | -45.80 | 80 | -55.86 | -33.46 | Superiority |
Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (1 DGAT2i-matching placebo tablet, 1 DGAT2i 25 mg tablet) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| OG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
|
|
Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (1 DGAT2i-matching placebo tablet, 1 DGAT2i 25 mg tablet) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| OG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
|
|
| OG001 | PF-06865571 25 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (1 DGAT2i-matching placebo tablet, 1 DGAT2i 25 mg tablet) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| OG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
|
|
| OG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| OG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
|
|
| OG001 | PF-06865571 25 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (1 DGAT2i-matching placebo tablet, 1 DGAT2i 25 mg tablet) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| OG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
|
|
| OG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| OG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
|
|
Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (1 DGAT2i-matching placebo tablet, 1 DGAT2i 25 mg tablet) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG002 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 50 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
| OG003 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. The morning dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 20 mg tablet). The evening dose contained 2 large tablets (2 DGAT2i-matching placebo tablets) plus 1 small tablet (ACCi-matching placebo tablet). Two follow-up visits were scheduled after end of treatment. |
| OG004 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | Participants had 2 oral doses per day (1 dose with the morning meal and 1 dose with the evening meal) for up to 6 weeks. Each dose contained 2 large tablets (2 DGAT2i 150 mg tablets) plus 1 small tablet (ACCi 10 mg tablet). Two follow-up visits were scheduled after end of treatment. |
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