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This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional).
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Obesity | Experimental | Part B |
|
| Placebo Obesity | Placebo Comparator | Part B |
|
| Active T2DM | Experimental | Parts A and C |
|
| Placebo T2DM | Placebo Comparator | Parts A and C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07081532 | Drug | Investigational Drug once daily for up to 42 days; multiple ascending dose design. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Treatment-emergent are events between first dose of study intervention and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C) |
| Number of Participants With Laboratory Abnormalities | Participants with laboratory abnormalities with ≥2 occurrences (without regard to baseline abnormality) that met pre-specified criteria were High-density lipoprotein (HDL) Cholesterol <0.8✕ lower limit of normal (LLN); Bicarbonate <0.9✕LLN; Calcitonin>1.0✕upper limit of normal (ULN); Triglycerides >1.3✕ULN; Aspartate Aminotransferase >3.0✕ULN; Low-density lipoprotein (LDL) Cholesterol >1.2✕ULN; Urine Glucose ≥1; Urine Ketones ≥1; Urine Leukocyte Esterase ≥1; Urine Leukocytes ≥20; Urine Hyaline Casts >1; Urine Hemoglobin ≥1; and Urine Nitrite ≥1. | From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C) |
| Number of Participants With Vital Signs Abnormalities | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure < 90 millimeters of mercury (mmHg), supine systolic blood pressure increase/decrease from baseline ≥ 30mmHg; supine diastolic blood pressure <50 mmHg, supine diastolic blood pressure increase/decrease from baseline ≥ 20mmHg; pulse rate <40 beats per minute (bpm) or >120 bpm. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time 0 to 24 Hours (AUC24) Post Dose for PF-07081532 | AUC24 is defined as area under the concentration-time profile from time 0 to 24 hours using Linear/Log trapezoidal method. | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C |
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Key Inclusion Criteria for participants enrolling with T2DM:
Key Exclusion Criterion for participants enrolling with T2DM:
-Type 1 Diabetes or secondary forms of diabetes.
Key Inclusion Criterion for participants enrolling with obesity:
-Obese (as indicated by screening BMI) non-diabetic adults.
Key Exclusion Criterion for participants enrolling with obesity:
--Type 1 or Type 2 Diabetes or secondary forms of diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Qps-Mra, Llc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38751362 | Derived | Buckeridge C, Tsamandouras N, Carvajal-Gonzalez S, Brown LS, Hernandez-Illas M, Saxena AR. Once-daily oral small-molecule glucagon-like peptide-1 receptor agonist lotiglipron (PF-07081532) for type 2 diabetes and obesity: Two randomized, placebo-controlled, multiple-ascending-dose Phase 1 studies. Diabetes Obes Metab. 2024 Aug;26(8):3155-3166. doi: 10.1111/dom.15643. Epub 2024 May 16. |
| 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 66 participants were assigned to treatment and received at least 1 dose of study intervention; of these, 61 participants completed the blinded treatment. Of the 5 participants who discontinued study treatment, 3 were due to treatment-related adverse events (AEs), and 2 were due to other reasons. One participant discontinued from study due to withdrawal by participant and other 65 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Part A | Adult participants with type 2 diabetes mellitus (T2DM) received oral placebo once daily (QD) over 28 days. |
| FG001 | PF-07081532 10 mg Part A | Adult participants with T2DM received oral PF-07081532 10 milligrams (mg) QD over 28 days. |
| FG002 | PF-07081532 30 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 30 mg over 28 days. |
| FG003 | PF-07081532 60 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 60 mg over 28 days. |
| FG004 | PF-07081532 120 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 120 mg over 28 days. |
| FG005 | Placebo Part B | Adult participants with Obesity (without diabetes) received oral placebo QD over 42 days. |
| FG006 | PF-07081532 180 mg Part B | Adult participants with Obesity (without diabetes) received oral PF-07081532 QD titrated from 10 mg to a target dose of 180 mg over 42 days. |
| FG007 | Placebo Part C | Adult participants with T2DM received oral placebo QD over 42 days. |
| FG008 | PF-07081532 180 mg Part C | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 180 mg over 42 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants received at least 1 dose of study intervention (PF-07081532 or placebo) and were included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Part A | Adult participants with type 2 diabetes mellitus (T2DM) received oral placebo once daily (QD) over 28 days. |
| BG001 | PF-07081532 10 mg Part A | Adult participants with T2DM received oral PF-07081532 10 milligrams (mg) QD over 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Number of Participants With Treatment Emergent Treatment-Related Adverse Events | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. Treatment-emergent are events between first dose of study intervention and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | The population for this outcome measure included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C) |
From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C)
MedDRA 24.0 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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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 Part A | Adult participants with type 2 diabetes mellitus (T2DM) received oral placebo once daily (QD) over 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bandaemia | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| 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 | Jan 16, 2020 | Jul 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2020 | Jul 11, 2022 | 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 |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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double-blind (investigator- and participant-blind), sponsor-open
| Placebo | Other | Placebo once daily for up to 42 days. |
|
| Clopidogrel | Drug | Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41. |
|
|
| From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C) |
| Number of Participants With Abnormal Electrocardiogram (ECG) | The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥ 300 milliseconds (msec), percentage change ≥ 25/50%; QRS duration: value ≥140 msec, percentage change ≥ 50%; QTcF interval: 450 < value ≤ 480 msec, 480 < value ≤ 500 msec, value >500 msec, and 30<change ≤ 60 msec, change >60 msec. | From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C) |
| Maximum Observed Plasma Concentration (Cmax) for PF-07081532 |
Cmax is defined as maximum plasma concentration observed directly from data. |
| 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532 | Tmax is defined as time for Cmax observed directly from data as time of first occurrence. | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C |
| Time Measured for the Plasma Concentration to Decrease by One-Half (t1/2) for PF-07081532 | t1/2 is defined as the time measured for the plasma concentration to decrease by one half. | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Day 28 for Part A, on Day 42 for Part B and Part C |
| Cumulative Amount of Drug Recovered Unchanged in Urine Over 24 Hours (Ae24) for PF-07081532 | Ae24 is defined as cumulative amount of drug recovered unchanged in urine over 24 hours using the method of urine concentration * volume of urine. | Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours) |
| Percentage of Ae24 (Ae24%) for PF-07081532 | Ae24% is defined as percent of dose recovered unchanged in urine over the 24 hours using the method of 100 * Ae24/Dose | Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours) |
| Renal Clearance (CLr) for PF-07081532 | Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine over the dosing interval tau (Aetau) divided by area under the concentration time-curve from time 0 to time tau (AUCtau) | Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours) |
| South Miami |
| Florida |
| 33143 |
| United States |
| BG002 | PF-07081532 30 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 30 mg over 28 days. |
| BG003 | PF-07081532 60 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 60 mg over 28 days. |
| BG004 | PF-07081532 120 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 120 mg over 28 days. |
| BG005 | Placebo Part B | Adult participants with Obesity (without diabetes) received oral placebo QD over 42 days. |
| BG006 | PF-07081532 180 mg Part B | Adult participants with Obesity (without diabetes) received oral PF-07081532 QD titrated from 10 mg to a target dose of 180 mg over 42 days. |
| BG007 | Placebo Part C | Adult participants with T2DM received oral placebo QD over 42 days. |
| BG008 | PF-07081532 180 mg Part C | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 180 mg over 42 days. |
| BG009 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) Continuous | Mean | Standard Deviation | kilogram/meter^2 (kg/m^2) |
|
|
|
|
| Primary | Number of Participants With Laboratory Abnormalities | Participants with laboratory abnormalities with ≥2 occurrences (without regard to baseline abnormality) that met pre-specified criteria were High-density lipoprotein (HDL) Cholesterol <0.8✕ lower limit of normal (LLN); Bicarbonate <0.9✕LLN; Calcitonin>1.0✕upper limit of normal (ULN); Triglycerides >1.3✕ULN; Aspartate Aminotransferase >3.0✕ULN; Low-density lipoprotein (LDL) Cholesterol >1.2✕ULN; Urine Glucose ≥1; Urine Ketones ≥1; Urine Leukocyte Esterase ≥1; Urine Leukocytes ≥20; Urine Hyaline Casts >1; Urine Hemoglobin ≥1; and Urine Nitrite ≥1. | The population for this outcome measure included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C) |
|
|
|
| Primary | Number of Participants With Vital Signs Abnormalities | Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure < 90 millimeters of mercury (mmHg), supine systolic blood pressure increase/decrease from baseline ≥ 30mmHg; supine diastolic blood pressure <50 mmHg, supine diastolic blood pressure increase/decrease from baseline ≥ 20mmHg; pulse rate <40 beats per minute (bpm) or >120 bpm. | The population for this outcome measure included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C) |
|
|
|
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) | The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥ 300 milliseconds (msec), percentage change ≥ 25/50%; QRS duration: value ≥140 msec, percentage change ≥ 50%; QTcF interval: 450 < value ≤ 480 msec, 480 < value ≤ 500 msec, value >500 msec, and 30<change ≤ 60 msec, change >60 msec. | The population for this outcome measure included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C) |
|
|
|
| Secondary | Area Under the Curve From Time 0 to 24 Hours (AUC24) Post Dose for PF-07081532 | AUC24 is defined as area under the concentration-time profile from time 0 to 24 hours using Linear/Log trapezoidal method. | The population for this outcome measure included all randomized participants who received at least 1 dose of PF-07081532 and had at least 1 of the pharmacokinetics (PK) parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*hr/mL) | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) for PF-07081532 | Cmax is defined as maximum plasma concentration observed directly from data. | The population for this outcome measure included all randomized participants who received at least 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532 | Tmax is defined as time for Cmax observed directly from data as time of first occurrence. | The population for this outcome measure included all randomized participants who received at least 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated. | Posted | Median | Full Range | hour | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C |
|
|
|
| Secondary | Time Measured for the Plasma Concentration to Decrease by One-Half (t1/2) for PF-07081532 | t1/2 is defined as the time measured for the plasma concentration to decrease by one half. | The population for this outcome measure included all randomized participants who received at least 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated. | Posted | Mean | Standard Deviation | hour | 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Day 28 for Part A, on Day 42 for Part B and Part C |
|
|
|
| Secondary | Cumulative Amount of Drug Recovered Unchanged in Urine Over 24 Hours (Ae24) for PF-07081532 | Ae24 is defined as cumulative amount of drug recovered unchanged in urine over 24 hours using the method of urine concentration * volume of urine. | The population for this outcome measure included all randomized participants with T2DM who received at least 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours) |
|
|
|
| Secondary | Percentage of Ae24 (Ae24%) for PF-07081532 | Ae24% is defined as percent of dose recovered unchanged in urine over the 24 hours using the method of 100 * Ae24/Dose | The population for this outcome measure included all randomized participants with T2DM who received at least 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of Ae24 | Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours) |
|
|
|
| Secondary | Renal Clearance (CLr) for PF-07081532 | Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine over the dosing interval tau (Aetau) divided by area under the concentration time-curve from time 0 to time tau (AUCtau) | The population for this outcome measure included all randomized participants with T2DM who received at least 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/hr) | Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours) |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 7 |
| 9 |
| EG001 | PF-07081532 10 mg Part A | Adult participants with T2DM received oral PF-07081532 10 milligrams (mg) QD over 28 days. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG002 | PF-07081532 30 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 30 mg over 28 days. | 0 | 8 | 1 | 8 | 7 | 8 |
| EG003 | PF-07081532 60 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 60 mg over 28 days. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG004 | PF-07081532 120 mg Part A | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 120 mg over 28 days. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG005 | Placebo Part B | Adult participants with Obesity (without diabetes) received oral placebo QD over 42 days. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG006 | PF-07081532 180 mg Part B | Adult participants with Obesity (without diabetes) received oral PF-07081532 QD titrated from 10 mg to a target dose of 180 mg over 42 days. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG007 | Placebo Part C | Adult participants with T2DM received oral placebo QD over 42 days. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG008 | PF-07081532 180 mg Part C | Adult participants with T2DM received oral PF-07081532 QD titrated from 10 mg to a target dose of 180 mg over 42 days. | 0 | 9 | 0 | 9 | 9 | 9 |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Early satiety | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA version 24.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA version 24.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Mental impairment | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 24.0 | Non-systematic Assessment |
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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 |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN |
|
|
| Calcitonin (pg/mL) >1.0✕ULN |
|
|
| Triglycerides (mg/dL) >1.3✕ULN |
|
|
| Aspartate Aminotransferase (U/L) >3.0✕ULN |
|
|
| LDL Cholesterol (mg/dL) >1.2✕ULN |
|
|
| Urine Glucose ≥1 |
|
|
| Urine Ketones ≥1 |
|
|
| Urine Leukocyte Esterase ≥1 |
|
|
| Urine Leukocytes (/high power field [HPF]) ≥20 |
|
|
| Urine Hyaline Casts (/low power field [LPF]) >1 |
|
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| Urine Hemoglobin ≥1 |
|
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| Urine Nitrite ≥1 |
|
|
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase |
|
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease |
|
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg |
|
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase |
|
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease |
|
| Pulse Rate (bpm) - Value <40 bpm |
|
| Pulse Rate (bpm) - Value >120 bpm |
|
| PR Interval (msec) - %Change ≥ 25/50% |
|
| QRS Duration (msec) - Value ≥140 |
|
| QRS Duration (msec) - %Change ≥ 50% |
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| QTcF Interval (msec) - 450 < Value ≤ 480 |
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| QTcF Interval (msec) - 480 < Value ≤ 500 |
|
| QTcF Interval (msec) - Value >500 |
|
| QTcF Interval (msec) -30 < Change ≤ 60 |
|
| QTcF Interval (msec) -Change >60 |
|
| AUC24 (Day 28 or 42) |
|
| Cmax (Day 28 or 42) |
|
| Tmax (Day 28 or 42) |
|