Phase 1
Completed N=37
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT04552470 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 3; 7; 9; 9 Participants
Summary
This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled, twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM inadequately controlled on diet and exercise alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
3; 7; 9; 9; 0; 0 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities |
9; 10; 8; 9 | — |
| PRIMARY Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961 |
414.4; 500.3; 484.5; 2424; 4691; 6953 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) Observed of PF-06882961 |
32.83; 45.89; 39.35; 206.1; 352.2; 551.7 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961 |
12.0; 12.0; 12.0; 12.0; 12.9; 12.0 | — |
| SECONDARY Terminal Phase Half-Life (t1/2) of PF-06882961 |
6.373; 5.543; 5.300 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with T2DM who are treated with diet and exercise
- HbA1c greater than or equal to 7% and less than or equal to 10.5%
- Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2
Exclusion Criteria
- Any condition possibly affecting drug absorption
- Diagnosis of Type 1 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
- Symptomatic gallbladder disease
- Known medical history of active proliferative retinopathy and/or macular edema
- Known history of HIV, hepatitis B, hepatitis C or syphilis
- 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
Data sourced from ClinicalTrials.gov (NCT04552470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.