Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
Lead Sponsor:
Pfizer
Conditions:
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2023
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT04707313
Start Date
January 29 2021
End Date
October 11 2023
Last Update
November 5 2024
Active Locations (41)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
3
Velocity Clinical Research - Westlake
Los Angeles, California, United States, 90057
4
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, United States, 33134