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

Last updated: November 8, 2022
Sponsor: Pfizer
Overall Status: Completed

Phase

2

Condition

Diabetic Vitreous Hemorrhage

Diabetic Retinopathy

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT04617275
C3421008
GLP-1Ra Ph 2 Titration Study
  • Ages 18-75
  • All Genders

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 ischemicattack within 6 months of screening (Visit 1).
  • Participants with a known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, or primarybiliary 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.

Study Design

Total Participants: 151
Study Start date:
January 06, 2021
Estimated Completion Date:
November 17, 2021

Connect with a study center

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Unity Health - Searcy Medical Center

    Searcy, Arkansas 72143
    United States

    Site Not Available

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California 92262
    United States

    Site Not Available

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • California Research Foundation

    San Diego, California 92123-1881
    United States

    Site Not Available

  • University Clinical Investigators, Inc.

    Tustin, California 92780
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Washington, District of Columbia 20011
    United States

    Site Not Available

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Acevedo Clinical Research Associates

    Miami, Florida 33142
    United States

    Site Not Available

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Research Integrity, LLC

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Nola Care LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Meridian Clinical Research, LLC DBA Regional Clinical Research

    Endwell, New York 13760
    United States

    Site Not Available

  • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

    Cary, North Carolina 27518
    United States

    Site Not Available

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • PMG Research of Hickory, LLC

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • PMG Research of Rocky Mount, LLC - Investigational Product and Mail delivery

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • PMG Research of Rocky Mount, LLC - Patient Visits

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • Carolina Research Center, Inc.

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Sterling Research Group, Ltd.

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Palmetto Clinical Research

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Palmetto Primary Care Physicians (physicals only)

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Juno Research, LLC

    Houston, Texas 77074
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Bountiful Internal Medicine

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Progressive Clinical Research

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Wade Family Medicine

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

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