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

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ClinicalTrials.gov Identifier: NCT04707313
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 11, 2021
First Posted Date  ICMJE January 13, 2021
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE January 29, 2021
Estimated Primary Completion Date April 9, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2021)
Percent change from baseline in body weight [ Time Frame: Baseline, Week 26 (End of Treatment) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Body weight loss of greater than or equal to 5% [ Time Frame: Baseline, Week 26 (End of Treatment) ]
  • Percent change from baseline in body weight [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18 and 22 ]
  • Absolute change from baseline in waist circumference [ Time Frame: Baseline, Week 26 (End of Treatment) ]
  • Absolute change from baseline in waist-to-hip ratio [ Time Frame: Baseline, Week 26 (End of Treatment) ]
  • Absolute change from baseline in hemoglobin A1c [ Time Frame: Baseline, Week 16 and 26 ]
  • Absolute change from baseline in fasting plasma glucose [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18, 22 and 26 ]
  • Incidence of treatment emergent adverse events (AEs and SAEs) [ Time Frame: Baseline up to Week 31 ]
  • Incidence of treatment emergent clinically significant laboratory abnormalities [ Time Frame: Baseline up to Week 28 ]
  • Incidence of treatment emergent clinically significant vital sign abnormalities [ Time Frame: Baseline up to Week 28 ]
  • Incidence of treatment emergent clinically significant electrocardiogram (ECG) abnormalities [ Time Frame: Baseline up to Week 28 ]
  • Number of participants with categorical scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline up to Week 28 ]
  • Number of participants with categorical scores on the Patient Health Questionniare-9 (PHQ-9) [ Time Frame: Baseline up to Week 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2021)
  • Body weight loss of greater than or equal to 5% [ Time Frame: Baseline, Week 26 (End of Treatment) ]
  • Percent change from baseline in body weight [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18 and 22 ]
  • Absolute change from baseline in waist circumference [ Time Frame: Baseline, Week 26 (End of Treatment) ]
  • Absolute change from baseline in waist-to-hip ratio [ Time Frame: Baseline, Week 26 (End of Treatment) ]
  • Absolute change from baseline in hemoglobin A1c [ Time Frame: Baseline, Week 16 and 26 ]
  • Absolute change from baseline in fasting plasma glucose [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 18, 22 and 26 ]
  • Incidence of treatment emergent adverse events (AEs and SAEs) [ Time Frame: Baseline up to Week 31 ]
  • Incidence of treatment emergent clinically significant laboratory abnormalities [ Time Frame: Baseline up to Week 28 ]
  • Incidence of treatment emergent clinically significant vital sign abnormalities [ Time Frame: Baseline up to Week 28 ]
  • Incidence of treatment emergent clinically significant electrocardiogram (ECG) abnormalities [ Time Frame: Baseline up to Week 28 ]
  • Number of participants with categorical scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline up to Week 28 ]
  • Number of participants with categorical scores on the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline up to Week 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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