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COMPLETEDPHASE1

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus

AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE ADULTS WITH TYPE 2 DIABETES MELLITUS

NCT04889157•Pfizer

View on ClinicalTrials.gov

Summary

This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.

Eligibility

Age

20 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
•HbA1c greater than or equal to 7% and less than or equal to 10.5%
•Total body weight \>50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m\^2

Exclusion Criteria

•Any condition possibly affecting drug absorption
•Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes
•History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening
•Any malignancy not considered cured
•Personal or family history of MTC or MEN2, or participants with suspected MTC
•Acute pancreatitis or history of chronic pancreatitis
•Acute gallbladder disease
•Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them
•Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
•Clinically relevant ECG abnormalities
+2 more criteria

Locations (1)

Peking University Third Hospital

Beijing, China

Key Dates

Start Date

July 7, 2021

Primary Completion Date

February 17, 2022

Completion Date

February 17, 2022

Last Updated

October 1, 2024

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

PF-06882961

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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