A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY

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NCT04617275

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Study Location
Arizona Research Center
Phoenix, Arizona, 85053, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes, Obesity
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

- Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.


- History of myocardial infarction, unstable angina, arterial revascularization, stroke,
New York Heart Association Functional Class II IV heart failure, or transient ischemic
attack within 6 months of screening (Visit 1).


- Participants with a known medical history of active liver disease (other than non
alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary
biliary cirrhosis.


- History of major depressive disorder or history of other severe psychiatric disorders
(eg, schizophrenia or bipolar disorder) within the last 2 years.


- Any lifetime history of a suicide attempt.

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Diabetes, ObesityA 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
NCT04617275
  1. Phoenix, Arizona
  2. Searcy, Arkansas
  3. Montclair, California
  4. Palm Springs, California
  5. San Diego, California
  6. Tustin, California
  7. Walnut Creek, California
  8. Clearwater, Florida
  9. Miami, Florida
  10. Pembroke Pines, Florida
  11. Meridian, Idaho
  12. Chesterfield, Missouri
  13. Cary, North Carolina
  14. Hickory, North Carolina
  15. Rocky Mount, North Carolina
  16. Rocky Mount, North Carolina
  17. Shelby, North Carolina
  18. Beaver, Pennsylvania
  19. Summerville, South Carolina
  20. Houston, Texas
  21. Shavano Park, Texas
  22. Bountiful, Utah
  23. Bountiful, Utah
  24. Bountiful, Utah
  25. Manassas, Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
Official Title  ICMJE A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY
Brief Summary This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID) administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and in non-diabetic adults with obesity
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Obesity
Intervention  ICMJE
  • Drug: PF-06882961
    PF-68882961 will be provided as tablets twice a day (BID)
  • Other: Placebo
    Placebo comparator will be provided as tablets twice daily for 12 weeks
Study Arms  ICMJE
  • Experimental: Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM
    The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 120 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID
    Intervention: Drug: PF-06882961
  • Experimental: Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM
    The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID
    Intervention: Drug: PF-06882961
  • Experimental: Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM
    The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 80 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID
    Intervention: Drug: PF-06882961
  • Experimental: Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM
    The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 80 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID
    Intervention: Drug: PF-06882961
  • Placebo Comparator: Arm 5 - Placebo in subjects with T2DM and Obesity
    Matching Placebo tablets taken twice a day (BID)
    Intervention: Other: Placebo
  • Experimental: Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM
    The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID
    Intervention: Drug: PF-06882961
  • Experimental: Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity
    The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID
    Intervention: Drug: PF-06882961
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: October 30, 2020)		140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 16, 2021
Estimated Primary Completion Date October 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.
  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II IV heart failure, or transient ischemic attack within 6 months of screening (Visit 1).
  • Participants with a known medical history of active liver disease (other than non alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary biliary cirrhosis.
  • History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years.
  • Any lifetime history of a suicide attempt.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04617275
Other Study ID Numbers  ICMJE C3421008
GLP-1Ra Ph 2 Titration Study ( Other Identifier: Alias Study Number )
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:Yes
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….
URL: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 January 2021

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