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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: PF-06882961

Study type: Interventional

Funder types: Industry

Identifiers

NCT04889157

C3421028

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No 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
• Positive urine drug test
• Clinical relevant laboratory tests abnormalities

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

PF-06882961

Experimental group

Description:

Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg

Treatment:

Drug: PF-06882961

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo