A 26-Week, 2-Part Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

NCT04707313

Last updated date
Study Location
ActivMed Practices & Research, LLC
Methuen, Massachusetts, 01844, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2

- Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1

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


- Any condition possibly affecting drug absorption


- Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of
diabetes


- History of myocardial infarction, unstable angina, arterial revascularization, stroke,
heart failure, or transient ischemic attack within 6 months prior to visit 1


- Any malignancy not considered cured


- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine
Neoplasia syndrome type 2 or suspected MTC


- History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any
history of chronic pancreatitis


- Symptomatic gallbladder disease


- Medical history or characteristics suggestive of genetic or syndromic obesity or
obesity induced by other endocrinological disorders


- History of major depressive disorder or other severe psychiatric disorders within the
last 2 years


- Any lifetime history of a suicide attempt


- Known medical history of active liver disease, including chronic active hepatitis B or
C, or primary biliary cirrhosis


- Known history of HIV


- Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or
equal to 100 mmHg (diastolic)


- Clinically relevant ECG abnormalities


- Positive urine drug screen


- Participation in a formal weight reduction program within 90 days prior to visit 1

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Pfizer Clinical Trials Contact Center

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[email protected]

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ObesityA 26-Week, 2-Part Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
NCT04707313
  1. Methuen, Massachusetts
  2. Anniston, Alabama
  3. Anaheim, California
  4. Los Angeles, California
  5. Orlando, Florida
  6. Gurnee, Illinois
  7. Evansville, Indiana
  8. Valparaiso, Indiana
  9. Topeka, Kansas
  10. Louisville, Kentucky
  11. Omaha, Nebraska
  12. Omaha, Nebraska
  13. Hickory, North Carolina
  14. Raleigh, North Carolina
  15. Salisbury, North Carolina
  16. Wilmington, North Carolina
  17. Fargo, North Dakota
  18. Cleveland, Ohio
  19. Moncks Corner, South Carolina
  20. North Charleston, South Carolina
  21. Summerville, South Carolina
  22. Summerville, South Carolina
  23. Bristol, Tennessee
  24. Bristol, Tennessee
  25. Bristol, Tennessee
  26. Knoxville, Tennessee
  27. Winnipeg, Manitoba
  28. Brampton, Ontario
  29. London, Ontario
  30. Toronto, Ontario
  31. Chicoutimi, Quebec
  32. Sherbrooke, Quebec
  33. Quebec,
  34. Quebec,
  35. Suita-shi, Osaka
  36. Chuo-ku, Tokyo
  37. Chuo-ku, Tokyo
  38. Shinjuku-ku, Tokyo
ALL GENDERS
18 Years+
years
MULTIPLE SITES
ObesityPharmacokinetics Of Tigecycline In Morbidly Obese Subjects
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  1. Albany, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A 26-Week, 2-Part Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
Official Title  ICMJE A 26-WEEK, PHASE 2B, 2-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY
Brief Summary This study will assess the efficacy, safety, tolerability and pharmacokinetics (PK) of PF-06882961 in adults with obesity. The first part of the study, Part A, consists of study treatment dosing in Weeks 1 to 16. The second part of the study, Part B, is planned such that participants in Part A will continue dosing from Weeks 17 through 26, contingent upon supportive data. The planned End of Treatment is expected to be Week 26. If Part B is not conducted, then End of Treatment will be Week 16.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: Placebo
    4 matching placebo tablets taken twice daily
  • Drug: PF-06882961
    Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg) achieved through 1-week titration steps (standard titration) or 3 active target dose levels (120, 160 or 200 mg) achieved through 2-week titration steps (slow titration), taking 4 tablets twice daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06882961 40 milligrams (mg) twice daily (BID), standard titration
    The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID. Titration steps include: 10 mg BID, 20 mg BID, and 40 mg BID.
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 80 mg BID, standard titration
    The dose will be titrated with 1 week of dosing at each step 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
  • Experimental: PF-06882961 120 mg BID, standard titration
    The dose will be titrated with 1 week of dosing at each step 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: PF-06882961 160 mg BID, standard titration
    The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID, 120 mg BID, 140 mg BID and 160 mg BID.
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 200 mg BID, standard titration
    The dose will be titrated with 1 week of dosing at each step 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, 120 mg BID, 140 mg BID, 160 mg BID, 180 mg BID and 200 mg BID.
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 120 mg BID, slow titration
    The dose will be titrated with 2 weeks of dosing at each step 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: PF-06882961 160 mg BID, slow titration
    The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg, 100 mg BID, 120 mg BID, 140 mg BID and 160 mg BID.
    Intervention: Drug: PF-06882961
  • Experimental: PF-06882961 200 mg BID, slow titration
    The dose will be titrated with 2 weeks of dosing at each step 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, 120 mg BID, 140 mg BID, 160 mg BID, 180 mg BID and 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: January 11, 2021)
420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 7, 2022
Estimated Primary Completion Date April 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2
  • Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1

Exclusion Criteria:

  • Any condition possibly affecting drug absorption
  • Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes
  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1
  • Any malignancy not considered cured
  • Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC
  • History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis
  • Symptomatic gallbladder disease
  • Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders
  • History of major depressive disorder or other severe psychiatric disorders within the last 2 years
  • Any lifetime history of a suicide attempt
  • Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
  • Known history of HIV
  • Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
  • Clinically relevant ECG abnormalities
  • Positive urine drug screen
  • Participation in a formal weight reduction program within 90 days prior to visit 1
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,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04707313
Other Study ID Numbers  ICMJE C3421019
2020-001312-19 ( EudraCT Number )
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
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 April 2021

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