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Trial record 1 of 1 for:    NCT04617275
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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

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ClinicalTrials.gov Identifier: NCT04617275
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 30, 2020
First Posted Date  ICMJE November 5, 2020
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE January 6, 2021
Estimated Primary Completion Date September 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
Incidence and severity of treatment emergent adverse events (AEs and SAEs) [ Time Frame: Baseline through followup (Day 112) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
  • Change from baseline in fasting plasma glucose [ Time Frame: Baseline through followup (Day 91) ]
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline through followup (Day 91) ]
  • Change from baseline in body weight [ Time Frame: Baseline through followup (Day 91) ]
  • Incidence of treatment emergent clinical laboratory abnormalities [ Time Frame: Baseline through Visit 10 (Day 91) ]
  • Incidence of treatment emergent vital signs [ Time Frame: Baseline through Visit 10 (Day 91) ]
  • Incidence of treatment emergent Electrocardiogram (ECG) abnormalities [ Time Frame: Baseline through Visit 10 (Day 91) ]
  • Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through Visit 10 (Day 91) ]
  • Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline through Visit 10 (Day 91) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Obesity
Intervention  ICMJE
  • Drug: PF-06882961
    PF-68882961 will be provided as tablets twice a day (BID)
  • Other: Placebo
    Placebo comparator will be provided as tablets twice daily for 12 weeks
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: PF-06882961
  • Experimental: 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
    Intervention: Drug: PF-06882961
  • Experimental: 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
    Intervention: Drug: PF-06882961
  • Experimental: 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
    Intervention: Drug: PF-06882961
  • Placebo Comparator: Arm 5 - Placebo in subjects with T2DM and Obesity
    Matching Placebo tablets taken twice a day (BID)
    Intervention: Other: Placebo
  • Experimental: 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
    Intervention: Drug: PF-06882961
  • Experimental: 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
    Intervention: Drug: PF-06882961
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2020)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 24, 2021
Estimated Primary Completion Date September 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04617275
Other Study ID Numbers  ICMJE C3421008
GLP-1Ra Ph 2 Titration Study ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP