Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000218-12 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PF-06882961 2.5 milligrams (mg) | Experimental |
| |
| PF-06882961 10 mg | Experimental |
| |
| PF-06882961 40 mg | Experimental | Participants will be titrated up to 2 weeks to reach desired dose level |
|
| PF-06882961 80 mg | Experimental | Participants will be titrated up to 4 weeks to reach desired dose level |
|
| PF-06882961 120 mg | Experimental | Participants will be titrated up to 6 weeks to reach desired dose level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 4 matching placebo tablets taken twice a day (BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Baseline, Week 16 |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Trinity Medical Clinic | Harbor City | California | 90710 | United States | ||
| Innovative Clinical Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37213102 | Derived | Saxena AR, Frias JP, Brown LS, Gorman DN, Vasas S, Tsamandouras N, Birnbaum MJ. Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314493. doi: 10.1001/jamanetworkopen.2023.14493. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
A total of 859 participants were screened in the study, among whom, 412 participants were randomized, and 411 participants were treated with PF-06882961 (Danuglipron)/placebo; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. |
| FG001 | PF-06882961 2.5mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DOUBLE-BLIND TREATMENT |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2020 | Jun 2, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| PF-06882961 |
| Drug |
Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks. |
|
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. |
| Baseline, Week 2 |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Baseline, Week 4 |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Baseline, Week 6 |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Baseline, Week 8 |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Baseline, Week 12 |
| Change From Baseline in Fasting Plasma Glucose at Week 2 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL. | Baseline, Week 2 |
| Change From Baseline in Fasting Plasma Glucose at Week 4 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Baseline, Week 4 |
| Change From Baseline in Fasting Plasma Glucose at Week 6 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Baseline, Week 6 |
| Change From Baseline in Fasting Plasma Glucose at Week 8 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Baseline, Week 8 |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Baseline, Week 12 |
| Change From Baseline in Fasting Plasma Glucose at Week 16 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Baseline, Week 16 |
| Change From Baseline in Body Weight at Week 2 | Weight was 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. | Baseline, Week 2 |
| Change From Baseline in Body Weight at Week 4 | Weight was 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. | Baseline, Week 4 |
| Change From Baseline in Body Weight at Week 6 | Weight was 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. | Baseline, Week 6 |
| Change From Baseline in Body Weight at Week 8 | Weight was 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. | Baseline, Week 8 |
| Change From Baseline in Body Weight at Week 12 | Weight was 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. | Baseline, Week 12 |
| Change From Baseline in Body Weight at Week 16 | Weight was 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. | Baseline, Week 16 |
| Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | An adverse event (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. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent. | Baseline up to Week 21 |
| Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, PT/INR, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol). | Baseline Through Week 21 |
| Number of Participants With Treatment Emergent Vital Signs Abnormalities | 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 greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg. | Baseline through Week 21 |
| Number of Participants With Treatment Emergent ECG Abnormalities | ECG categorical abnormality criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline. | Baseline Through Week 21 |
| Harbor City |
| California |
| 90710 |
| United States |
| Long Beach Clinical Trials Services, Inc. | Long Beach | California | 90806 | United States |
| National Research Institute | Los Angeles | California | 90057 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Empire Clinical Research | Pomona | California | 91767 | United States |
| Rancho Cucamonga Clinical Research | Rancho Cucamonga | California | 91730 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| University Clinical Investigators, Incorporated | Tustin | California | 92780 | United States |
| San Fernando Valley Health Institute, LLC | Van Nuys | California | 91405 | United States |
| Diablo Clinical Research Incorporated | Walnut Creek | California | 94598 | United States |
| Accel Research Sites - DeLand Clinical Research Unit | DeLand | Florida | 32720 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32204 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| NewPhase Clinical Trials, Corp. | Miami Beach | Florida | 33140 | United States |
| Sunshine Research Center, Inc | Opa-locka | Florida | 33054 | United States |
| Andres Patron D.O. P.A. | Pembroke Pines | Florida | 33026 | United States |
| Ellipsis Group | Alpharetta | Georgia | 30022 | United States |
| East Coast Institute for Research, LLC | Macon | Georgia | 31210 | United States |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Buynak Clinical Research | Valparaiso | Indiana | 46383 | United States |
| Viable Research Management LLC | Henderson | Nevada | 89014 | United States |
| Premier Research | Trenton | New Jersey | 08611 | United States |
| PharmQuest | Greensboro | North Carolina | 27408 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| Velocity Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Conrad Clinical Research | Edmond | Oklahoma | 73013 | United States |
| Family Medical Associates | Levittown | Pennsylvania | 19056 | United States |
| Preferred Primary Care Physicians, Inc. | Pittsburgh | Pennsylvania | 15236 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| Palmetto Primary Care Physicians (physicals only) | Summerville | South Carolina | 29485 | United States |
| Dallas Diabetes Research Center | Dallas | Texas | 75230 | United States |
| Endocrine Associates | Houston | Texas | 77004 | United States |
| PrimeCare Medical Group | Houston | Texas | 77024 | United States |
| Juno Research, LLC | Houston | Texas | 77074 | United States |
| Northeast Clinical Research of San Antonio | Live Oak | Texas | 78233 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | United States |
| MHAT Dobrich AD | Dobrich | 9300 | Bulgaria |
| Medical Center ASKLEPII OOD | Dupnitsa | 2600 | Bulgaria |
| UMHAT Pulmed | Plovdiv | 4002 | Bulgaria |
| Fourth MHAT - Sofia EAD | Sofia | 1606 | Bulgaria |
| MHAT "Doverie" AD | Sofia | 1632 | Bulgaria |
| MC "New rehabilitation center" EOOD | Stara Zagora | 6000 | Bulgaria |
| GA Research Associates Ltd. | Moncton | New Brunswick | E1G 1A7 | Canada |
| Aggarwal and Associates Limited | Brampton | Ontario | L6T 0G1 | Canada |
| Manna Research (Toronto) | Toronto | Ontario | M9W4L6 | Canada |
| Manna Research (Quebec) | Lévis | Quebec | G6W 0M5 | Canada |
| Manna Research (Mirabel) | Mirabel | Quebec | J7J 2K8 | Canada |
| Diex Recherche Quebec Inc. | Québec | Quebec | G1N 4V3 | Canada |
| Alpha Recherche Clinique | Québec | Quebec | G3K2P8 | Canada |
| Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Diex Recherche Victoriaville Inc. | Victoriaville | Quebec | G6P 6P6 | Canada |
| Centre de Recherche Saint-Louis | Québec | G1W 4R4 | Canada |
| Belinus Orvosi es Szamitastechnikai Bt | Debrecen | 4025 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| CRU Hungary Kft. | Miskolc | 3529 | Hungary |
| Borbanya Praxis Egeszsegugyi KFT | Nyíregyháza | H-4405 | Hungary |
| Clinfan Kft. | Szekszárd | H-7100 | Hungary |
| Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik | Bialystok | 15-351 | Poland |
| Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET Sp. z o. o. | Krakow | 31-261 | Poland |
| Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer | Lodz | 94-060 | Poland |
| MEDICOME Sp. z o.o. | Oświęcim | 32-600 | Poland |
| KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek Badań Klinicznych w Puławach | Puławy | 24-100 | Poland |
| Centralny Szpital Kliniczny MSWiA | Warsaw | 02-507 | Poland |
| Metabol KLINIK s.r.o. | Bratislava | 811 08 | Slovakia |
| Medispektrum, s.r.o | Bratislava | 851 01 | Slovakia |
| HUMAN-CARE, s.r.o. | Košice | 040 01 | Slovakia |
| SchronerMED s.r.o. | Moldava nad Bodvou | 04501 | Slovakia |
| Funkystuff, s.r.o. | Nové Zámky | 940 01 | Slovakia |
| DIAB s.r.o. | Rožňava | 048 01 | Slovakia |
| MUDr. Jana Rociakova, s.r.o. | Žilina | 010 01 | Slovakia |
| Yonsei University-Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea |
| Hanyang University Guri Hospital | Guri-si | Gyeonggi-do | 11923 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Samsung Medical Center | Gangnam-Gu | Seoul | 06351 | South Korea |
| Far Eastern Memorial Hospital | New Taipei City | 220 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
| FG002 | PF-06882961 10mg BID | PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. |
| FG003 | PF-06882961 40mg BID | PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| FG004 | PF-06882961 80mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| FG005 | PF-06882961 120mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| FOLLOW-UP |
|
|
A total of 412 participants were assigned to treatment, 411 of whom were treated; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. |
| BG001 | PF-06882961 2.5mg BID | PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. |
| BG002 | PF-06882961 10mg BID | PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. |
| BG003 | PF-06882961 40mg BID | PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| BG004 | PF-06882961 80mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| BG005 | PF-06882961 120mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Age Range | Median | Full Range | Years |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Percent | Baseline, Week 16 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Number | Percentage of Participants | Baseline, Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Percent | Baseline, Week 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Percent | Baseline, Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Percent | Baseline, Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Percent | Baseline, Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Percent | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 2 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 4 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 6 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 8 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 12 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 16 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | mg/dL | Baseline, Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight at Week 2 | Weight was 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. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Kilogram | Baseline, Week 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight at Week 4 | Weight was 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. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Kilogram | Baseline, Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight at Week 6 | Weight was 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. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Kilogram | Baseline, Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight at Week 8 | Weight was 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. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Kilogram | Baseline, Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight at Week 12 | Weight was 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. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Kilogram | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight at Week 16 | Weight was 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. | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Least Squares Mean | 90% Confidence Interval | Kilogram | Baseline, Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | An adverse event (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. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent. | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to Week 21 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, PT/INR, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol). | Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 measurement available. | Posted | Count of Participants | Participants | Baseline Through Week 21 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Vital Signs Abnormalities | 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 greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg. | Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available. | Posted | Count of Participants | Participants | Baseline through Week 21 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent ECG Abnormalities | ECG categorical abnormality criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline. | Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available. | Posted | Count of Participants | Participants | Baseline Through Week 21 |
|
Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (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 | Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. | 0 | 66 | 1 | 66 | 15 | 66 |
| EG001 | PF-06882961 2.5mg BID | PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. | 1 | 68 | 1 | 68 | 21 | 68 |
| EG002 | PF-06882961 10mg BID | PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. | 0 | 68 | 2 | 68 | 17 | 68 |
| EG003 | PF-06882961 40mg BID | PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. | 2 | 71 | 6 | 71 | 33 | 71 |
| EG004 | PF-06882961 80mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. | 0 | 67 | 2 | 67 | 40 | 67 |
| EG005 | PF-06882961 120mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. | 0 | 71 | 1 | 71 | 35 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.0 | 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 | Jul 21, 2021 | Jun 2, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000731016 | danuglipron |
Not provided
Not provided
Not provided
| 45-64 Years |
|
| >=65 Years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Not reported |
|
Mixed Model Repeated Measures (MMRM) |
| <.0001 |
| Difference in LS Mean |
| -0.90 |
| 2-Sided |
| 90 |
| -1.18 |
| -0.62 |
PF-06882961 = Test Placebo = Reference |
| Superiority |
| Mixed Models Analysis | Mixed Model Repeated Measures (MMRM) | <.0001 | Difference in LS Mean | -1.01 | 2-Sided | 90 | -1.30 | -0.73 | PF-06882961 = Test Placebo = Reference | Superiority |
| Mixed Models Analysis | Mixed Model Repeated Measures (MMRM) | <.0001 | Difference in LS Mean | -0.94 | 2-Sided | 90 | -1.24 | -0.65 | PF-06882961 = Test Placebo = Reference | Superiority |
| Mixed Models Analysis | Mixed Model Repeated Measures (MMRM) | <.0001 | Difference in LS Mean | -1.16 | 2-Sided | 90 | -1.47 | -0.86 | PF-06882961 = Test Placebo = Reference | Superiority |
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
| PF-06882961 10 mg BID |
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. |
| OG003 | PF-06882961 40 mg BID | PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
| OG002 | PF-06882961 10 mg BID | PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. |
| OG003 | PF-06882961 40 mg BID | PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
| OG003 | PF-06882961 40 mg BID | PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
| OG002 | PF-06882961 10 mg BID | PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. |
| OG003 | PF-06882961 40 mg BID | PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG004 | PF-06882961 80 mg BID | PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
| OG005 | PF-06882961 120 mg BID | PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. |
|
|
|
|
|
|
|
|
|
|