Phase 1
Completed N=20
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT04889157 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1 — 287.4 nanogram*hour per milliter (ng*hr/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1 |
287.4 | — |
| PRIMARY Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1 |
37.37 | — |
| PRIMARY AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961 |
1446; 1012; 984.9 | — |
| PRIMARY Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961 |
150.3; 98.92; 110.5 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs |
1; 3; 0; 2; 1; 6 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram (ECG) |
0; 1; 1; 1 | — |
| SECONDARY Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) |
5; 14; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
0; 1; 0; 1; 0; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04889157). 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.