Phase 2
N=75
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Nonalcoholic Steatohepatitis · Nonalcoholic Fatty Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT04399538 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: 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 — -3.58; -54.07; -58.14; -60.28 Percent change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-06865571 (Drug); PF-05221304 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-3.58; -54.07; -58.14; -60.28; -47.75 | <0.0001 sig |
| SECONDARY Percent CFB in Fasting Serum Triglycerides at Week 6 |
3.72; 27.89; 18.00; 24.88; 14.69 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
2; 4; 5; 6; 7; 0 | — |
| SECONDARY Number of Participants With TEAEs of Special Interest by Preferred Term (PT) |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Abnormalities in Laboratory Parameters of Special Interest Meeting Pre-Defined Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Post-Baseline Vital Signs Data Meeting Pre-Defined Criteria |
0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Pre-Defined Criteria |
1; 0; 0; 0; 1; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- BMI ≥25 and ≤ 40 kg/m2
- concomitant medical conditions associated with NAFLD
Exclusion Criteria
- Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
- Any condition possibly affecting drug absorption
- Unstable liver function tests
- Recent cardiovascular event(s),
- Malignancies
Data sourced from ClinicalTrials.gov (NCT04399538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.