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This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06882961 | Experimental | Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06882961 | Drug | Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1 | AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor. | Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1 |
| Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1 | Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor. | Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1 |
| AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961 | AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor. | Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID) |
| Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961 | Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor. | Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest and maximum absolute values and maximum changes from baseline from time-matched baseline were evaluated at the investigator's discretion. |
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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 |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100089 | China |
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| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56. |
| FG001 | PF-06882961 BID | Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BLINDED TREATMENT |
| ||||||||||||||||
| Follow-Up |
|
All enrolled participants who were randomized and received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56. |
| BG001 | PF-06882961 BID | Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1 | AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor. | All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliter (ng*hr/mL) | Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1 |
|
Baseline up to 35 days after last dose (Day 91)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo BID (except QD in the morning on Day 1) from Days 1-56. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
In this study, a Quality Event was identified upon review of the PK data after the final study database release. This Quality Event was identified as non-compliance to study intervention per retrospective investigation post database release. Due to the Quality Event, the PK results of the study were considered not reliable by the sponsor and should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Dec 10, 2020 | Jan 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2022 | Jan 17, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000731016 | danuglipron |
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| Placebo | Drug | 3 matching placebo tablets taken twice daily (BID) except Day 1 (QD) |
|
| Baseline up to 14 days after last dose (Day 70) |
| Number of Participants With Abnormal Electrocardiogram (ECG) | Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex. | Baseline up to 14 days after last dose (Day 70) |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. 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. | Baseline up to 35 days after last dose (Day 91) |
| Number of Participants With Laboratory Abnormalities | Laboratory tests (including hematological, clinical chemistry, urinalysis tests) were reported and abnormality was determined at the investigator's discretion. | Baseline up to 14 days after last dose (Day 70) |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1 | Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor. | All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliter (ng/mL) | Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest and maximum absolute values and maximum changes from baseline from time-matched baseline were evaluated at the investigator's discretion. | All participants randomly assigned to study intervention and who had at least 1 dose of study intervention. | Posted | Count of Participants | Participants | No | Baseline up to 14 days after last dose (Day 70) |
|
|
|
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) | Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex. | All participants randomly assigned to study intervention and who had at least 1 dose of study intervention. | Posted | Count of Participants | Participants | No | Baseline up to 14 days after last dose (Day 70) |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. 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. | All participants randomly assigned to study intervention and who had at least 1 dose of study intervention. | Posted | Count of Participants | Participants | No | Baseline up to 35 days after last dose (Day 91) |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities | Laboratory tests (including hematological, clinical chemistry, urinalysis tests) were reported and abnormality was determined at the investigator's discretion. | All participants randomly assigned to study intervention and who had at least 1 dose of study intervention. | Posted | Count of Participants | Participants | No | Baseline up to 14 days after last dose (Day 70) |
|
|
|
| Primary | AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961 | AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor. | All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID) |
|
|
|
| Primary | Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961 | Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor. | All participants randomized and treated with PF-06882961 who had at least 1 plasma concentration value collected. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | PF-06882961 BID | Participants received PF-06882961 BID (except QD in the morning on Day 1) following dose titration schema: 10 mg on Days 1-7, 20 mg on Days 8-14, 40 mg on Days 15-21, 60 mg on Days 22-28, 80 mg on Days 29-35, 100 mg BID on Days 36-42, 120 mg from Days 43-56. | 0 | 15 | 0 | 15 | 14 | 15 |
| Palpitations | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
|
| Decreased appetite | 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 |
|
| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Sleep deficit | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue 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.
| D004700 | Endocrine System Diseases |
| Supine diastolic blood pressure (mmHg) change >=20 mm Hg increase |
|
| Supine diastolic blood pressure (mmHg) change >=20 mm Hg decrease |
|
| Supine pulse rate (beats per minute [bpm]) value >120 bpm |
|
| Chemistry - Urate (mg/dL) >1.2xULN |
|
| Chemistry - high-density lipoprotein cholesterol (mg/dL) <0.8xlower limit of normal (LLN) |
|
| Chemistry - Triglycerides (mg/dL) >1.3xULN |
|
| Chemistry - Thyrotropin (uIU/mL) <0.8xLLN |
|
| Chemistry - Bile Acid (umol/L) >1.0xULN |
|
| Urinalysis - Urine Glucose ≥1 |
|
| Urinalysis - Urine Ketones (Scalar) ≥1 |
|
| Urinalysis - Urine Protein ≥1 |
|
| Urinalysis - Urine Hemoglobin (Scalar) ≥1 |
|
| Urinalysis - Urine Urobilinogen ≥1 |
|
| Urinalysis - Urine Nitrite (Scalar) ≥1 |
|
| Urinalysis - Urine Leukocyte Esterase (Scalar) ≥1 |
|