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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes, Obesity

In brief

This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID) administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and in non-diabetic adults with obesity

Key facts

Study ID

NCT04617275

Run by

Pfizer

People needed

151

Starts

2021-01-06

Expected to finish

2021-11-17

Last updated by the study team

2022-12-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).

You may not qualify if…

• 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.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Unity Health - Searcy Medical Center — Searcy, Arkansas, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Rancho Cucamonga Clinical Research — Rancho Cucamonga, California, United States
• California Research Foundation — San Diego, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Acevedo Clinical Research Associates — Miami, Florida, United States
• Pines Care Research Center, LLC — Pembroke Pines, Florida, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Meridian Clinical Research, LLC — Sioux City, Iowa, United States
• Research Integrity, LLC — Owensboro, Kentucky, United States
• Nola Care LLC — Metairie, Louisiana, United States
• Clinical Research Professionals — Chesterfield, Missouri, United States
• Meridian Clinical Research, LLC DBA Regional Clinical Research — Endwell, New York, United States
• PMG Research of Raleigh, LLC d/b/a PMG Research of Cary — Cary, North Carolina, United States
• PMG Research of Charlotte, LLC — Charlotte, North Carolina, United States
• PMG Research of Hickory, LLC — Hickory, North Carolina, United States
• PMG Research of Rocky Mount, LLC - Investigational Product and Mail delivery — Rocky Mount, North Carolina, United States
• PMG Research of Rocky Mount, LLC - Patient Visits — Rocky Mount, North Carolina, United States
• Carolina Research Center, Inc. — Shelby, North Carolina, United States

Full record on ClinicalTrials.gov

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