Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
NCT04305587
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
for participants enrolling with T2DM:
- Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.
- HbA1c value between 7.0% and 10.5%, inclusive.
Key Exclusion Criterion for participants enrolling with T2DM:
-Type 1 Diabetes or secondary forms of diabetes.
Key Inclusion Criterion for participants enrolling with obesity:
-Obese (as indicated by screening BMI) non-diabetic adults.
Key Exclusion Criterion for participants enrolling with obesity:
--Type 1 or Type 2 Diabetes or secondary forms of diabetes.
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Descriptive Information | |||||
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Brief Title ICMJE | Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus | ||||
Official Title ICMJE | A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus | ||||
Brief Summary | This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional). The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Masking Description: double-blind (investigator- and participant-blind), sponsor-open Primary Purpose: Basic Science
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Condition ICMJE | Diabetes Mellitus Type 2 | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 22, 2021 | ||||
Estimated Primary Completion Date | May 22, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria for participants enrolling with T2DM:
Key Exclusion Criterion for participants enrolling with T2DM: -Type 1 Diabetes or secondary forms of diabetes. Key Inclusion Criterion for participants enrolling with obesity: -Obese (as indicated by screening BMI) non-diabetic adults. Key Exclusion Criterion for participants enrolling with obesity: --Type 1 or Type 2 Diabetes or secondary forms of diabetes. | ||||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04305587 | ||||
Other Study ID Numbers ICMJE | C3991002 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |