A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06882961 TITRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH METFORMIN AND IN NON-DIABETIC ADULTS WITH OBESITY
Sponsor: Pfizer
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Time frame: Baseline through follow-up (Day 112)
Secondary Endpoints
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Eligibility Criteria
Inclusion Criteria: * Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening). Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes. * History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II IV heart failure, or transient ischemic attack within 6 months of screening (Visit 1). * Participants with a known medical history of active liver disease (other than non alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary biliary cirrhosis. * History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years. * Any lifetime history of a suicide attempt.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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