| Outcome Measures: |
Primary: Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity, 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)., Baseline through follow-up (Day 112) | Secondary: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality), Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion., Baseline through Visit 10 (Day 91)|Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria, Vital signs abnormality 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 \>=30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>=20 mmHg., Baseline through Visit 10 (Day 91)|Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria, ECG assessments included pulse rate (PR), QT, heart rate, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value \>= 300 msec, or baseline (BL) \>200 msec and \>=25% increase from BL, or BL \<=200 msec and \>=50% increase from BL; QRS interval value \>= 140msec, or \>=50% increase from BL; QTcF value \>450 and \<=480 msec, or \>480 and \<=500 msec, or \>500 msec, or increase from BL\>30 and \<=60 msec, or \>60msec., Baseline through Visit 10 (Day 91)|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS), The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Participants who responded "yes" to the questions will be counted. Data relevant to the assessment of suicidality were mapped to the Columbia-Classification Algorithm of Suicide Assessment (C-CASA) codes., Week 0, 2, 4, 6, 8, 10, 12, 13-14|Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9), The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 were completed by participants and reviewed by site staff at the pre-defined time points., Week 0, 2, 4, 6, 8, 10, 12, 13-14.|Change From Baseline (CFB) in Fasting Plasma Glucose at Week 2, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 2|CFB in Fasting Plasma Glucose at Week 4, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 4|CFB in Fasting Plasma Glucose at Week 6, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 6|CFB in Fasting Plasma Glucose at Week 8, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 8|CFB in Fasting Plasma Glucose at Week 10, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 10|CFB in Fasting Plasma Glucose at Week 12, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 12|CFB in Glycolated Hemoglobin A1c (HbA1c) at Week 2, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 2|CFB in Glycolated HbA1c at Week 4, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 4|CFB in Glycolated HbA1c at Week 6, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 6|CFB in Glycolated HbA1c at Week 8, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 8|CFB in Glycolated HbA1c at Week 10, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 10|CFB in Glycolated HbA1c at Week 12, Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points., Baseline, Week 12|CFB in Body Weight at Week 2 (Participants With T2DM), Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses., Baseline, Week 2|CFB in Body Weight at Week 4 (Participants With T2DM), Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses., Baseline, Week 4|CFB in Body Weight at Week 6 (Participants With T2DM), Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses., Baseline, Week 6|CFB in Body Weight at Week 8 (Participants With T2DM), Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses., Baseline, Week 8|CFB in Body Weight at Week 10 (Participants With T2DM), Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses., Baseline, Week 10|CFB in Body Weight at Week 12 (Participants With T2DM), Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses., Baseline, Week 12|CFB in Body Weight at Week 2 (Non-diabetic Participants With Obesity), Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement., Baseline, Week 2|CFB in Body Weight at Week 4 (Non-diabetic Participants With Obesity), Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement., Baseline, Week 4|CFB in Body Weight at Week 6 (Non-diabetic Participants With Obesity), Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement., Baseline, Week 6|CFB in Body Weight at Week 8 (Non-diabetic Participants With Obesity), Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement., Baseline, Week 8|CFB in Body Weight at Week 10 (Non-diabetic Participants With Obesity), Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement., Baseline, Week 10|CFB in Body Weight at Week 12 (Non-diabetic Participants With Obesity), Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement., Baseline, Week 12
|
| Locations: |
Arizona Research Center, Phoenix, Arizona, 85053, United States|Unity Health - Searcy Medical Center, Searcy, Arkansas, 72143, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Desert Oasis Healthcare Medical Group, Palm Springs, California, 92262, United States|Rancho Cucamonga Clinical Research, Rancho Cucamonga, California, 91730, United States|California Research Foundation, San Diego, California, 92123-1881, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Emerson Clinical Research Institute, Washington, District of Columbia, 20011, United States|Innovative Research of West Florida, Inc., Clearwater, Florida, 33756, United States|Clinical Neuroscience Solutions, Inc., Jacksonville, Florida, 32256, United States|Acevedo Clinical Research Associates, Miami, Florida, 33142, United States|Pines Care Research Center, LLC, Pembroke Pines, Florida, 33024, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Meridian Clinical Research, LLC, Sioux City, Iowa, 51106, United States|Research Integrity, LLC, Owensboro, Kentucky, 42303, United States|Nola Care LLC, Metairie, Louisiana, 70006, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|Meridian Clinical Research, LLC DBA Regional Clinical Research, Endwell, New York, 13760, United States|PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary, North Carolina, 27518, United States|PMG Research of Charlotte, LLC, Charlotte, North Carolina, 28209, United States|PMG Research of Hickory, LLC, Hickory, North Carolina, 28601, United States|PMG Research of Rocky Mount, LLC - Investigational Product and Mail delivery, Rocky Mount, North Carolina, 27804, United States|PMG Research of Rocky Mount, LLC - Patient Visits, Rocky Mount, North Carolina, 27804, United States|Carolina Research Center, Inc., Shelby, North Carolina, 28150, United States|PMG Research of Winston-Salem, LLC, Winston-Salem, North Carolina, 27103, United States|Sterling Research Group, Ltd., Cincinnati, Ohio, 45219, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Palmetto Clinical Research, Summerville, South Carolina, 29485, United States|Palmetto Primary Care Physicians (physicals only), Summerville, South Carolina, 29485, United States|Clinical Neuroscience Solutions, Inc., Memphis, Tennessee, 38119, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Juno Research, LLC, Houston, Texas, 77074, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Bountiful Internal Medicine, Bountiful, Utah, 84010, United States|Progressive Clinical Research, Bountiful, Utah, 84010, United States|Wade Family Medicine, Bountiful, Utah, 84010, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States
|
