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
NCT ID: NCT04617275
Last Updated: 2022-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2021-01-06
2021-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 120 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID
PF-06882961
PF-68882961 will be provided as tablets twice a day (BID)
Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID
PF-06882961
PF-68882961 will be provided as tablets twice a day (BID)
Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 80 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID
PF-06882961
PF-68882961 will be provided as tablets twice a day (BID)
Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 80 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID
PF-06882961
PF-68882961 will be provided as tablets twice a day (BID)
Arm 5 - Placebo in subjects with T2DM and Obesity
Matching Placebo tablets taken twice a day (BID)
Placebo
Placebo comparator will be provided as tablets twice daily for 12 weeks
Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM
The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID
PF-06882961
PF-68882961 will be provided as tablets twice a day (BID)
Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity
The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID
PF-06882961
PF-68882961 will be provided as tablets twice a day (BID)
Interventions
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PF-06882961
PF-68882961 will be provided as tablets twice a day (BID)
Placebo
Placebo comparator will be provided as tablets twice daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Palmetto Primary Care Physicians (physicals only)
Summerville, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Bountiful Internal Medicine
Bountiful, Utah, United States
Progressive Clinical Research
Bountiful, Utah, United States
Wade Family Medicine
Bountiful, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Countries
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References
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Saxena AR, Frias JP, Gorman DN, Lopez RN, Andrawis N, Tsamandouras N, Birnbaum MJ. Tolerability, safety and pharmacodynamics of oral, small-molecule glucagon-like peptide-1 receptor agonist danuglipron for type 2 diabetes: A 12-week, randomized, placebo-controlled, Phase 2 study comparing different dose-escalation schemes. Diabetes Obes Metab. 2023 Oct;25(10):2805-2814. doi: 10.1111/dom.15168. Epub 2023 Jun 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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GLP-1Ra Ph 2 Titration Study
Identifier Type: OTHER
Identifier Source: secondary_id
C3421008
Identifier Type: -
Identifier Source: org_study_id
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