Status:
COMPLETED
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Lead Sponsor:
Pfizer
Conditions:
Nonalcoholic Steatohepatitis
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 tr...
Eligibility Criteria
Inclusion
- BMI ≥25 and ≤ 40 kg/m2
- concomitant medical conditions associated with NAFLD
Exclusion
- 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
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04399538
Start Date
August 10 2020
End Date
April 28 2022
Last Update
April 13 2023
Active Locations (20)
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1
Clinical Trials Research
Lincoln, California, United States, 95648
2
Catalina Research Institute, LLC
Montclair, California, United States, 91763
3
Excel Medical Clinical Trials
Boca Raton, Florida, United States, 33434
4
Optimus U Corporation
Miami, Florida, United States, 33125