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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 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

NCT04617275

CompletedPhase 2

Sponsor: Pfizer

Conditions: Diabetes, Obesity

Interventions: PF-06882961, Placebo

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (38)
  • Phoenix, Arizona, United States
  • Searcy, Arkansas, United States
  • Montclair, California, United States
  • Palm Springs, California, United States
  • Rancho Cucamonga, California, United States
  • San Diego, California, United States
  • Tustin, California, United States
  • Walnut Creek, California, United States
  • Washington D.C., District of Columbia, United States
  • Clearwater, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Pembroke Pines, Florida, United States
  • Meridian, Idaho, United States
  • Sioux City, Iowa, United States
  • Owensboro, Kentucky, United States
  • Metairie, Louisiana, United States
  • Chesterfield, Missouri, United States
  • Endwell, New York, United States
  • Cary, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Hickory, North Carolina, United States
  • Rocky Mount, North Carolina, United States
  • Rocky Mount, North Carolina, United States
  • Shelby, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Beaver, Pennsylvania, United States
  • Summerville, South Carolina, United States
  • Summerville, South Carolina, United States
  • + 8 more on CT.gov