A 26-Week, 2-Part Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
NCT04707313
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |