Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis

NCT04399538

Last updated date
Study Location
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Contact
1-800-718-1021

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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
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
  1. Montclair, California
  2. Halifax, Nova Scotia
  3. Halifax, Nova Scotia
  4. Halifax, Nova Scotia
  5. Hialeah, Florida
  6. Honolulu, Hawaii
  7. Louisville, Kentucky
  8. Cincinnati, Ohio
  9. Cincinnati, Ohio
  10. San Antonio, Texas
  11. Richmond, Virginia
  12. Brampton, Ontario
  13. Chicoutimi, Quebec
  14. Chicoutimi, Quebec
  15. Quebec,
  16. 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
Condition  ICMJE
  • Nonalcoholic Steatohepatitis
  • Nonalcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: PF-06865571
    Tablet
    Other Name: DGAT2i
  • Drug: PF-05221304
    Tablet
    Other Name: ACCi
  • Drug: Placebo
    Tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants will receive medication for 6 weeks
    Intervention: Drug: Placebo
  • Experimental: DGAT2i (25 mg BID) + ACCi (10 mg BID)
    Participants will receive medication for 6 weeks
    Interventions:
    • Drug: PF-06865571
    • Drug: PF-05221304
  • Experimental: DGAT2i (100 mg BID) + ACCi (10 mg BID)
    Participants will receive medication for 6 weeks
    Interventions:
    • Drug: PF-06865571
    • Drug: PF-05221304
  • Experimental: DGAT2i (300 mg QD) + ACCi (20 mg QD)
    Participants will receive medication for 6 weeks
    Interventions:
    • Drug: PF-06865571
    • Drug: PF-05221304
  • Experimental: DGAT2i (300 mg BID) + ACCi (10 mg BID)
    Participants will receive medication for 6 weeks
    Interventions:
    • Drug: PF-06865571
    • Drug: PF-05221304
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
 (submitted: August 16, 2020)
180
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2020)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP