Danuglipron

Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100 multiply by \[\*\](back-transformed LS Mean minus \[-\] 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.

Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.

An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. Assessments of AE intensity were defined as mild (easily tolerated, causing minimal discomfort and not interfering with daily activities), moderate (causing sufficient discomfort and interferes with normal daily activities) and severe (preventing normal daily activities).

HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.

AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.

Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.

AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.

Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.

Cmax was the maximum observed plasma concentration and was directly observed from data.

AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity.

AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.

Fu was defined as fraction of unbound drug in plasma.

AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.

AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment emergent AEs were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.

Leukocytes (10\^9/liter \[L\]) bilirubin (micromol/L), glucose (millimoles \[mmol\]/L), triacylglycerol lipase (microkatals \[microkat\]/L): greater than (\>) 1.5\*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1\*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits \[mU\]/L): less than (\<) 0.8\*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): \>1.2\*ULN; triglycerides: \>1.3\*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): \>3.0\*ULN; cholesterol (mmol/L): \>1.3\*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (\>=) 1; granular casts, hyaline casts: \>1.

Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP \<90 mmHg, maximum of SBP \>=30 mmHg decrease from baseline and maximum of SBP \>=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP \<50 mmHg, maximum of DBP \>20 mmHg decrease from baseline and maximum of DBP \>=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate \<40 BPM and maximum of absolute supine pulse rate \>120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1.

PR interval had following categories: maximum absolute PR interval \>=300 milliseconds (msec); when baseline PR interval \>200 msec and maximum increase from baseline in PR interval \>=25 percent; when baseline PR interval less than or equal to (\<=) 200 msec and maximum increase from baseline in PR interval \>=50 percent. QRS interval had following categories: maximum absolute QRS interval \>=140 msec; maximum increase from baseline in QRS interval \>=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval \>450 msec to \<=480 msec; absolute QTCF interval \>480 msec to \<=500 msec; absolute QTCF interval \>500 msec; QTCF interval increase from baseline \>=30 msec to \<=60 msec; QTCF interval increase from baseline \>60 msec.

Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).

Vital signs categorical summarization 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 summarization 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 duration (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