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

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

Tracking Information

• First Submitted Date: January 11, 2021
• First Posted Date: January 13, 2021
• Last Update Posted Date: April 6, 2021
• Actual Study Start Date: January 29, 2021
• Estimated Primary Completion Date: April 9, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 11, 2021): Percent change from baseline in body weight [ Time Frame: Baseline, Week 26 (End of Treatment) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: A 26-Week, 2-Part Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 11, 2021): 420
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 7, 2022
• Estimated Primary Completion Date: April 9, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

• Listed Location Countries: Canada, Japan, United States

Administrative Information

• NCT Number: NCT04707313
• Other Study ID Numbers: 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

• 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: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2021