Trial Outcomes & Findings for STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT (NCT NCT04604496)

A total of 29 participants were screened in the study, among whom, 24 participants were treated with PF-06882961 (Danuglipron).

STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT

Maximum observed plasma PF-06882961 concentration.

Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.

Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.

fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).

Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Relatedness to study treatment was determined by the investigator.

Protocol-required safety laboratory assessments included: hemoglobin \<0.8 x lower limit of normal (LLN), hematocrit \<0.8 x LLN, erythrocytes \<0.8 x LLN, ery. mean corpuscular volume \>1.1 x upper limit of normal (ULN), ery. mean corpuscular hemoglobin \>1.1 x ULN, platelets \<0.5 x LLN, eosinophils \>1.2 x ULN, activated partial thromboplastin time \>1.1 x ULN, prothrombin time \>1.1 x ULN, prothrombin intl. normalized ratio \>1.1 x ULN; bilirubin/direct bilirubin/indirect bilirubin \>1.5 x ULN, aspartate aminotransferase/alanine aminotransferase/gamma glutamyl transferase \>3.0 x ULN, albumin \<0.8 x LLN, urate \>1.2 x ULN, bicarbonate \>1.1 x ULN, triacylglycerol lipase \>1.5 x ULN; urine hemoglobin/urine urobilinogen/urine nitrite/urine leukocyte esterase ≥1.

Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.

ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (≥) 300 millisecond (msec), b) ≥25% increase when baseline is \> 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and ≤480 msec, b) \>480 msec and ≤500 msec, c) \>500 msec, d) \>30 msec and ≤60 msec increase from baseline, e) \>60 msec increase from baseline