A 26-Week, 2-Part Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
- Conditions
- Obesity
- Registration Number
- JPRN-jRCT2031200422
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 420
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method