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| ID | Type | Description | Link |
|---|---|---|---|
| GLP-1Ra Ph 2 Titration Study | Other Identifier | Alias Study Number |
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This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID) administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and in non-diabetic adults with obesity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM | Experimental | The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 120 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID |
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| Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM | Experimental | The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID |
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| Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM | Experimental | The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 80 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID |
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| Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM | Experimental | The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 80 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06882961 | Drug | PF-68882961 will be provided as tablets twice a day (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Unity Health - Searcy Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37311722 | Derived | Saxena AR, Frias JP, Gorman DN, Lopez RN, Andrawis N, Tsamandouras N, Birnbaum MJ. Tolerability, safety and pharmacodynamics of oral, small-molecule glucagon-like peptide-1 receptor agonist danuglipron for type 2 diabetes: A 12-week, randomized, placebo-controlled, Phase 2 study comparing different dose-escalation schemes. Diabetes Obes Metab. 2023 Oct;25(10):2805-2814. doi: 10.1111/dom.15168. Epub 2023 Jun 13. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 370 participants were screened for eligibility, of which 151 participants (123 in the type 2 diabetes mellitus [T2DM] arms and 28 in the non-diabetic obesity arms) were randomized to receive the danuglipron or placebo in one of the 8 treatment arms.
Participants were enrolled from 06 January 2021 to 17 November 2021 in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (T2DM) | Participants with T2DM received matching placebo tablets orally twice daily (BID) with food. |
| FG001 | PF-06882961 80 mg BID Low, Slow (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks in following steps: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2020 | Nov 8, 2022 |
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| Arm 5 - Placebo in subjects with T2DM and Obesity | Placebo Comparator | Matching Placebo tablets taken twice a day (BID) |
|
| Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM | Experimental | The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID |
|
| Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity | Experimental | The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID |
|
| Placebo | Other | Placebo comparator will be provided as tablets twice daily for 12 weeks |
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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 |
| 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 D.C. | 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 |
| FG002 | PF-06882961 80 mg BID High, Slow (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID. |
| FG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks in following steps: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID. |
| FG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID. |
| FG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 mg BID, 200 mg BID. |
| FG006 | Placebo (Non-diabetic Obesity) | Participants with non-diabetic obesity received matching placebo tablets orally BID with food. |
| FG007 | PF-06882961 200 mg BID (Non-diabetic Obesity) | Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 mg BID, 200 mg BID. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up Period |
|
|
A total of 151 participants were assigned to the treatment and treated with danuglipron or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (T2DM) | Participants with T2DM received matching placebo tablets orally twice daily (BID) with food. |
| BG001 | Placebo (Non-diabetic Obesity) | Participants with non-diabetic obesity received matching placebo tablets orally BID with food. |
| BG002 | PF-06882961 80 mg BID Low, Slow (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks. |
| BG003 | PF-06882961 80 mg BID High, Slow (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. |
| BG004 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| BG005 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| BG006 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
| BG007 | PF-06882961 200 mg BID (Non-diabetic Obesity) | Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Continuous | Median | Full Range | Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
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| 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). | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of investigational products (IP). | Posted | Count of Participants | Participants | Baseline through follow-up (Day 112) |
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| 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. | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP. | Posted | Count of Participants | Participants | Baseline through Visit 10 (Day 91) |
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| Secondary | 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. | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP. | Posted | Count of Participants | Participants | Baseline through Visit 10 (Day 91) |
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| Secondary | 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. | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP. | Posted | Count of Participants | Participants | Baseline through Visit 10 (Day 91) |
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| Secondary | 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. | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP. | Posted | Count of Participants | Participants | Week 0, 2, 4, 6, 8, 10, 12, 13-14 |
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| Secondary | 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. | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP. | Posted | Count of Participants | Participants | Week 0, 2, 4, 6, 8, 10, 12, 13-14. |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 2 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 4 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 6 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 8 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 10 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 12 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage | Baseline, Week 2 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage | Baseline, Week 4 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage | Baseline, Week 6 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage | Baseline, Week 8 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage | Baseline, Week 10 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage | Baseline, Week 12 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 2 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 4 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 6 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 8 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 10 |
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| Secondary | 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. | Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 12 |
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| Secondary | 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. | Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 2 |
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| Secondary | 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. | Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 4 |
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| Secondary | 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. | Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 6 |
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| Secondary | 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. | Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 8 |
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| Secondary | 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. | Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 10 |
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| Secondary | 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. | Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored. | Posted | Least Squares Mean | 90% Confidence Interval | kg | Baseline, Week 12 |
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Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (T2DM) | Participants with T2DM received matching placebo tablets orally twice daily (BID) with food. | 0 | 16 | 0 | 16 | 8 | 16 |
| EG001 | Placebo (Non-diabetic Obesity) | Participants with non-diabetic obesity received matching placebo tablets orally BID with food. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG002 | PF-06882961 80 mg BID Low, Slow (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks. | 0 | 20 | 0 | 20 | 11 | 20 |
| EG003 | PF-06882961 80 mg BID High, Slow (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. | 0 | 22 | 0 | 22 | 13 | 22 |
| EG004 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. | 0 | 22 | 0 | 22 | 14 | 22 |
| EG005 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. | 0 | 22 | 0 | 22 | 14 | 22 |
| EG006 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. | 0 | 21 | 0 | 21 | 14 | 21 |
| EG007 | PF-06882961 200 mg BID (Non-diabetic Obesity) | Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. | 0 | 22 | 0 | 22 | 18 | 22 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Pinguecula | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Pre-existing condition improved | General disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
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| Infected bite | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2021 | Nov 8, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000731016 | danuglipron |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| No longer meets eligibility criteria |
|
| Other |
|
| Withdrawal by Subject |
|
| 18-44 |
|
| 45-64 |
|
| >=65 |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Not reported |
|
| Not Hispanic or Latino |
|
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
| All Causality - Moderate |
|
| All Causality - Severe |
|
| Treatment Related - Mild |
|
| Treatment Related - Moderate |
|
| Treatment Related - Severe |
|
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
| OG006 | Placebo (Non-diabetic Obesity) | Participants with non-diabetic obesity received matching placebo tablets orally BID with food. |
| OG007 | PF-06882961 200 mg BID (Non-diabetic Obesity) | Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
| OG006 | Placebo (Non-diabetic Obesity) | Participants with non-diabetic obesity received matching placebo tablets orally BID with food. |
| OG007 | PF-06882961 200 mg BID (Non-diabetic Obesity) | Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
| OG006 | Placebo (Non-diabetic Obesity) | Participants with non-diabetic obesity received matching placebo tablets orally BID with food. |
| OG007 | PF-06882961 200 mg BID (Non-diabetic Obesity) | Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
| PF-06882961 80 mg BID High, Slow (T2DM) |
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG006 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
| OG007 | PF-06882961 200 mg BID (Non-diabetic Obesity) | Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
| OG004 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG006 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
| OG007 | PF-06882961 200 mg BID (Non-diabetic Obesity) | Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. |
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. |
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. |
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. |
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. |
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
|
|
|
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks. |
| OG003 | PF-06882961 120 mg BID Low, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks. |
| OG004 | PF-06882961 120 mg BID High, Fast (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks. |
| OG005 | PF-06882961 200 mg BID (T2DM) | Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks. |
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