Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
NCT04399538
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- BMI ≥25 and ≤ 40 kg/m2
- concomitant medical conditions associated with NAFLD
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver DiseaseStudy of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
NCT04399538
- Quebec,
- Montclair, California
- Hialeah, Florida
- Honolulu, Hawaii
- Louisville, Kentucky
- Cincinnati, Ohio
- Cincinnati, Ohio
- San Antonio, Texas
- Richmond, Virginia
- Halifax, Nova Scotia
- Halifax, Nova Scotia
- Halifax, Nova Scotia
- Brampton, Ontario
- Chicoutimi, Quebec
- Chicoutimi, Quebec
- Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis | ||||
| Official Title ICMJE | A PHASE 2A, 2-PART, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PLACEBO-CONTROLLED, PARALLEL-GROUP (SPONSOR OPEN) STUDY TO ASSESS PHARMACODYNAMICS AND SAFETY OF PF-06865571 (DGAT2I) COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH PRESUMED NONALCOHOLIC STEATOHEPATITIS (NASH) | ||||
| 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 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Dose-ranging of combination doses Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blind, Double-dummy, Placebo controlled Primary Purpose: Basic Science
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 180 | ||||
| Original Estimated Enrollment ICMJE | 90 | ||||
| Estimated Study Completion Date ICMJE | September 28, 2022 | ||||
| Estimated Primary Completion Date | September 28, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04399538 | ||||
| Other Study ID Numbers ICMJE | C3711005 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||
| Verification Date | February 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||