Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

NCT04305587

Last updated date
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus Type 2
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

for participants enrolling with T2DM:

- Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.

- HbA1c value between 7.0% and 10.5%, inclusive.

Key Exclusion Criterion for participants enrolling with T2DM:

-Type 1 Diabetes or secondary forms of diabetes.

Key Inclusion Criterion for participants enrolling with obesity:

-Obese (as indicated by screening BMI) non-diabetic adults.

Key Exclusion Criterion for participants enrolling with obesity:

--Type 1 or Type 2 Diabetes or secondary forms of diabetes.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Brief Summary

This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional).

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
double-blind (investigator- and participant-blind), sponsor-open
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus Type 2
Intervention  ICMJE
  • Drug: PF-07081532
    Investigational Drug once daily for up to 42 days; multiple ascending dose design.
  • Other: Placebo
    Placebo once daily for up to 42 days.
  • Drug: Clopidogrel
    Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
    Other Name: Plavix
Study Arms  ICMJE
  • Experimental: Active Obesity
    Part B
    Interventions:
    • Drug: PF-07081532
    • Drug: Clopidogrel
  • Placebo Comparator: Placebo Obesity
    Part B
    Interventions:
    • Other: Placebo
    • Drug: Clopidogrel
  • Experimental: Active T2DM
    Parts A and C
    Intervention: Drug: PF-07081532
  • Placebo Comparator: Placebo T2DM
    Parts A and C
    Intervention: Other: Placebo
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: March 9, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 22, 2021
Estimated Primary Completion Date May 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria for participants enrolling with T2DM:

  • Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.
  • HbA1c value between 7.0% and 10.5%, inclusive.

Key Exclusion Criterion for participants enrolling with T2DM:

-Type 1 Diabetes or secondary forms of diabetes.

Key Inclusion Criterion for participants enrolling with obesity:

-Obese (as indicated by screening BMI) non-diabetic adults.

Key Exclusion Criterion for participants enrolling with obesity:

--Type 1 or Type 2 Diabetes or secondary forms of diabetes.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04305587
Other Study ID Numbers  ICMJE C3991002
Has Data Monitoring Committee No
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
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
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 August 2020

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