Trial · NCT04399538
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
NCT04399538, Phase 2, Completed, Pfizer; results first posted 2023-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis. Trials, record NCT04399538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04399538
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
- NCT number
- NCT04399538
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
- Interventions
- PF-06865571, PF-05221304, Placebo
- First posted
- 2020-05-22
- Last updated
- 2023-04-13
- Results first posted
- 2023-04-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Baseline, 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. |
| Secondary | Percent CFB in Fasting Serum Triglycerides at Week 6 | Baseline, 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). |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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). | 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. |
| Secondary | Number of Participants With TEAEs of Special Interest by Preferred Term (PT) | 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). | 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. |
| Secondary | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality | From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks) | 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. |
| Secondary | Number of Participants With Abnormalities in Laboratory Parameters of Special Interest Meeting Pre-Defined Criteria | From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks) | 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. |
| Secondary | Number of Participants With Post-Baseline Vital Signs Data Meeting Pre-Defined Criteria | 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 | 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. |
| Secondary | Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Pre-Defined Criteria | 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 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline, Week 6 | 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. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent CFB in Fasting Serum Triglycerides at Week 6 | Baseline, Week 6 | 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. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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 analysis population included all participants who were randomized to study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs of Special Interest by Preferred Term (PT) | 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 analysis population included all participants who were randomized to study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality | From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormalities in Laboratory Parameters of Special Interest Meeting Pre-Defined Criteria | From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Post-Baseline Vital Signs Data Meeting Pre-Defined Criteria | 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 | The analysis population included all participants randomized who received at least 1 dose of study intervention and were evaluable for vital signs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Pre-Defined Criteria | 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 | The analysis population included all participants randomized who received at least 1 dose of study intervention and were evaluable for ECG. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group280
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Placebo | -3.58 | 80% Confidence Interval -14.71 to 8.99 | Percent change | |
| 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 | PF-06865571 25 mg BID + PF-05221304 10 mg BID | -54.07 | 80% Confidence Interval -59.54 to -47.85 | Percent change | |
| 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 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | -58.14 | 80% Confidence Interval -63.51 to -51.98 | Percent change | |
| 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 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | -60.28 | 80% Confidence Interval -65.27 to -54.57 | Percent change | |
| 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 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | -47.75 | 80% Confidence Interval -55.71 to -38.35 | Percent change | |
| Percent CFB in Fasting Serum Triglycerides at Week 6 | Placebo | 3.72 | 80% Confidence Interval -6.90 to 15.55 | Percent change | |
| Percent CFB in Fasting Serum Triglycerides at Week 6 | PF-06865571 25 mg BID + PF-05221304 10 mg BID | 27.89 | 80% Confidence Interval 14.75 to 42.53 | Percent change | |
| Percent CFB in Fasting Serum Triglycerides at Week 6 | PF-06865571 100 mg BID + PF-05221304 10 mg BID | 18.00 | 80% Confidence Interval 5.10 to 32.49 | Percent change | |
| Percent CFB in Fasting Serum Triglycerides at Week 6 | PF-06865571 300 mg QD + PF-05221304 20 mg QD | 24.88 | 80% Confidence Interval 12.85 to 38.20 | Percent change | |
| Percent CFB in Fasting Serum Triglycerides at Week 6 | PF-06865571 300 mg BID + PF-05221304 10 mg BID | 14.69 | 80% Confidence Interval 0.59 to 30.78 | Percent change |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment | STARTED | Placebo | 15 | |
| Double-Blind Treatment | STARTED | PF-06865571 25 mg Twice Daily (BID) + PF-05221304 10 mg BID | 15 | |
| Double-Blind Treatment | STARTED | PF-06865571 100 mg BID + PF-05221304 10 mg BID | 13 | |
| Double-Blind Treatment | STARTED | PF-06865571 300 mg Once Daily (QD) + PF-05221304 20 mg QD | 18 | |
| Double-Blind Treatment | STARTED | PF-06865571 300 mg BID + PF-05221304 10 mg BID | 14 | |
| Double-Blind Treatment | COMPLETED | Placebo | 15 | |
| Double-Blind Treatment | COMPLETED | PF-06865571 25 mg Twice Daily (BID) + PF-05221304 10 mg BID | 15 | |
| Double-Blind Treatment | COMPLETED | PF-06865571 100 mg BID + PF-05221304 10 mg BID | 13 | |
| Double-Blind Treatment | COMPLETED | PF-06865571 300 mg Once Daily (QD) + PF-05221304 20 mg QD | 17 | |
| Double-Blind Treatment | COMPLETED | PF-06865571 300 mg BID + PF-05221304 10 mg BID | 12 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events170
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 0 | 15 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | PF-06865571 25 mg BID + PF-05221304 10 mg BID | 1 | 15 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | PF-06865571 100 mg BID + PF-05221304 10 mg BID | 0 | 13 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | PF-06865571 300 mg QD + PF-05221304 20 mg QD | 0 | 18 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | PF-06865571 300 mg BID + PF-05221304 10 mg BID | 0 | 14 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 0 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | PF-06865571 25 mg BID + PF-05221304 10 mg BID | 0 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | PF-06865571 100 mg BID + PF-05221304 10 mg BID | 1 | 13 | |
| other | Neutropenia | Blood and lymphatic system disorders | PF-06865571 300 mg QD + PF-05221304 20 mg QD | 0 | 18 | |
| other | Neutropenia | Blood and lymphatic system disorders | PF-06865571 300 mg BID + PF-05221304 10 mg BID | 0 | 14 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 15 |
| Total, all-cause mortality | PF-06865571 25 mg BID + PF-05221304 10 mg BID | 0 | 15 |
| Total, all-cause mortality | PF-06865571 100 mg BID + PF-05221304 10 mg BID | 0 | 13 |
| Total, all-cause mortality | PF-06865571 300 mg QD + PF-05221304 20 mg QD | 0 | 18 |
| Total, all-cause mortality | PF-06865571 300 mg BID + PF-05221304 10 mg BID | 0 | 14 |
| Total, other adverse events | Placebo | 2 | 15 |
| Total, other adverse events | PF-06865571 25 mg BID + PF-05221304 10 mg BID | 4 | 15 |
| Total, other adverse events | PF-06865571 100 mg BID + PF-05221304 10 mg BID | 5 | 13 |
| Total, other adverse events | PF-06865571 300 mg QD + PF-05221304 20 mg QD | 6 | 18 |
| Total, other adverse events | PF-06865571 300 mg BID + PF-05221304 10 mg BID | 7 | 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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