← Trials/Trial dossier/NCT04305587
Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Lead sponsor
Asset
Lotiglipron
Oral · GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
66
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criterion
•HbA1c 7-10.5%
Primary endpoints
•Treatment-emergent AEs (any)•Laboratory Abnormalities•Vital Signs Abnormalities
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
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.
Endpoints (11)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
11 endpointsNumber of Participants With Treatment Emergent Treatment-Related Adverse Events
Time frame: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)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Part ATreatment-related AEs | 5 | — |
| Treatment-related SAEs | 0 | — |
| PF-07081532 10 mg Part ATreatment-related AEs | 2 | — |
| Treatment-related SAEs | 0 | — |
| PF-07081532 30 mg Part ATreatment-related AEs | 6 | — |
| Treatment-related SAEs | 1 | — |
| PF-07081532 60 mg Part ATreatment-related AEs | 6 | — |
| Treatment-related SAEs | 0 | — |
| PF-07081532 120 mg Part ATreatment-related AEs | 8 | — |
| Treatment-related SAEs | 0 | — |
| Placebo Part BTreatment-related AEs | 2 | — |
| Treatment-related SAEs | 0 | — |
| PF-07081532 180 mg Part BTreatment-related AEs | 11 | — |
| Treatment-related SAEs | 0 | — |
| Placebo Part CTreatment-related AEs | 2 | — |
| Treatment-related SAEs | 0 | — |
| PF-07081532 180 mg Part CTreatment-related AEs | 9 | — |
| Treatment-related SAEs | 0 | — |
Number of Participants With Laboratory Abnormalities
Time frame: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)
descriptive, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Part AHDL Cholesterol (mg/dL) <0.8✕LLN | 2 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 1 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 0 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 2 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 0 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 1 | — |
| Urine Glucose ≥1 | 3 | — |
| Urine Ketones ≥1 | 0 | — |
| Urine Leukocyte Esterase ≥1 | 1 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 1 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 0 | — |
| Urine Hemoglobin ≥1 | 1 | — |
| Urine Nitrite ≥1 | 1 | — |
| PF-07081532 10 mg Part AHDL Cholesterol (mg/dL) <0.8✕LLN | 0 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 0 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 0 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 0 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 0 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 0 | — |
| Urine Glucose ≥1 | 1 | — |
| Urine Ketones ≥1 | 0 | — |
| Urine Leukocyte Esterase ≥1 | 1 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 1 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 2 | — |
| Urine Hemoglobin ≥1 | 1 | — |
| Urine Nitrite ≥1 | 1 | — |
| PF-07081532 30 mg Part AHDL Cholesterol (mg/dL) <0.8✕LLN | 3 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 0 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 0 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 1 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 0 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 0 | — |
| Urine Glucose ≥1 | 2 | — |
| Urine Ketones ≥1 | 1 | — |
| Urine Leukocyte Esterase ≥1 | 3 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 2 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 2 | — |
| Urine Hemoglobin ≥1 | 1 | — |
| Urine Nitrite ≥1 | 1 | — |
| PF-07081532 60 mg Part AHDL Cholesterol (mg/dL) <0.8✕LLN | 2 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 0 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 1 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 0 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 0 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 0 | — |
| Urine Glucose ≥1 | 2 | — |
| Urine Ketones ≥1 | 1 | — |
| Urine Leukocyte Esterase ≥1 | 1 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 0 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 1 | — |
| Urine Hemoglobin ≥1 | 0 | — |
| Urine Nitrite ≥1 | 1 | — |
| PF-07081532 120 mg Part AHDL Cholesterol (mg/dL) <0.8✕LLN | 1 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 2 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 2 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 0 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 0 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 1 | — |
| Urine Glucose ≥1 | 3 | — |
| Urine Ketones ≥1 | 3 | — |
| Urine Leukocyte Esterase ≥1 | 1 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 0 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 3 | — |
| Urine Hemoglobin ≥1 | 0 | — |
| Urine Nitrite ≥1 | 0 | — |
| Placebo Part BHDL Cholesterol (mg/dL) <0.8✕LLN | 1 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 0 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 0 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 0 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 0 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 0 | — |
| Urine Glucose ≥1 | 0 | — |
| Urine Ketones ≥1 | 0 | — |
| Urine Leukocyte Esterase ≥1 | 0 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 0 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 0 | — |
| Urine Hemoglobin ≥1 | 0 | — |
| Urine Nitrite ≥1 | 0 | — |
| PF-07081532 180 mg Part BHDL Cholesterol (mg/dL) <0.8✕LLN | 1 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 0 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 1 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 0 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 2 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 2 | — |
| Urine Glucose ≥1 | 0 | — |
| Urine Ketones ≥1 | 3 | — |
| Urine Leukocyte Esterase ≥1 | 2 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 2 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 1 | — |
| Urine Hemoglobin ≥1 | 3 | — |
| Urine Nitrite ≥1 | 0 | — |
| Placebo Part CHDL Cholesterol (mg/dL) <0.8✕LLN | 1 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 0 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 0 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 0 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 0 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 0 | — |
| Urine Glucose ≥1 | 1 | — |
| Urine Ketones ≥1 | 0 | — |
| Urine Leukocyte Esterase ≥1 | 0 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 0 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 0 | — |
| Urine Hemoglobin ≥1 | 0 | — |
| Urine Nitrite ≥1 | 0 | — |
| PF-07081532 180 mg Part CHDL Cholesterol (mg/dL) <0.8✕LLN | 2 | — |
| Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN | 0 | — |
| Calcitonin (pg/mL) >1.0✕ULN | 0 | — |
| Triglycerides (mg/dL) >1.3✕ULN | 0 | — |
| Aspartate Aminotransferase (U/L) >3.0✕ULN | 0 | — |
| LDL Cholesterol (mg/dL) >1.2✕ULN | 0 | — |
| Urine Glucose ≥1 | 1 | — |
| Urine Ketones ≥1 | 0 | — |
| Urine Leukocyte Esterase ≥1 | 3 | — |
| Urine Leukocytes (/high power field [HPF]) ≥20 | 0 | — |
| Urine Hyaline Casts (/low power field [LPF]) >1 | 1 | — |
| Urine Hemoglobin ≥1 | 0 | — |
| Urine Nitrite ≥1 | 2 | — |
Number of Participants With Vital Signs Abnormalities
Time frame: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)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 2 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 1 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 1 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 1 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 0 | — |
| PF-07081532 10 mg Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 1 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 1 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 1 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 2 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 1 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 1 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 0 | — |
| PF-07081532 30 mg Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 1 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 2 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 1 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 0 | — |
| PF-07081532 60 mg Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 2 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 4 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 1 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 2 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 0 | — |
| PF-07081532 120 mg Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 3 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 1 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 1 | — |
| Placebo Part BSupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 0 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 0 | — |
| PF-07081532 180 mg Part BSupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 1 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 3 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 1 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 3 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 0 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 0 | — |
| Placebo Part CSupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 0 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 0 | — |
| PF-07081532 180 mg Part CSupine Systolic Blood Pressure (mmHg) - Value <90mmHg | 1 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase | 0 | — |
| Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease | 2 | — |
| Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase | 0 | — |
| Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease | 0 | — |
| Pulse Rate (bpm) - Value <40 bpm | 0 | — |
| Pulse Rate (bpm) - Value >120 bpm | 0 | — |
Number of Participants With Abnormal Electrocardiogram (ECG)
Time frame: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)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Placebo Part APR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 0 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 1 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 0 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
| PF-07081532 10 mg Part APR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 0 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 2 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 0 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
| PF-07081532 30 mg Part APR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 1 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 1 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 1 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
| PF-07081532 60 mg Part APR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 0 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 1 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 0 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
| PF-07081532 120 mg Part APR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 0 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 0 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 0 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
| Placebo Part BPR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 0 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 0 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 0 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
| PF-07081532 180 mg Part BPR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 0 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 0 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 2 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
| Placebo Part CPR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 0 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 0 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 0 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
| PF-07081532 180 mg Part CPR Interval (msec) - Value ≥300 | 0 | — |
| PR Interval (msec) - %Change ≥ 25/50% | 0 | — |
| QRS Duration (msec) - Value ≥140 | 0 | — |
| QRS Duration (msec) - %Change ≥ 50% | 0 | — |
| QTcF Interval (msec) - 450 < Value ≤ 480 | 0 | — |
| QTcF Interval (msec) - 480 < Value ≤ 500 | 0 | — |
| QTcF Interval (msec) - Value >500 | 0 | — |
| QTcF Interval (msec) -30 < Change ≤ 60 | 0 | — |
| QTcF Interval (msec) -Change >60 | 0 | — |
Area Under the Curve From Time 0 to 24 Hours (AUC24) Post Dose for PF-07081532
Time frame: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
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanogram*hour/milliliter (ng*hr/mL) | 95% CI |
|---|---|---|
| PF-07081532 10 mg Part AAUC24 (Day 1) | 15530 | — |
| AUC24 (Day 28 or 42) | 26380 | — |
| PF-07081532 30 mg Part AAUC24 (Day 1) | 14430 | — |
| AUC24 (Day 28 or 42) | 78930 | — |
| PF-07081532 60 mg Part AAUC24 (Day 1) | 17220 | — |
| AUC24 (Day 28 or 42) | 177000 | — |
| PF-07081532 120 mg Part AAUC24 (Day 1) | 15100 | — |
| AUC24 (Day 28 or 42) | 265400 | — |
| PF-07081532 180 mg Part BAUC24 (Day 1) | 14340 | — |
| AUC24 (Day 28 or 42) | 521300 | — |
| PF-07081532 180 mg Part CAUC24 (Day 1) | 14560 | — |
| AUC24 (Day 28 or 42) | 496500 | — |
Maximum Observed Plasma Concentration (Cmax) for PF-07081532
Time frame: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
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanogram/milliliter (ng/mL) | 95% CI |
|---|---|---|
| PF-07081532 10 mg Part ACmax (Day 1) | 1599 | — |
| Cmax (Day 28 or 42) | 2263 | — |
| PF-07081532 30 mg Part ACmax (Day 1) | 1518 | — |
| Cmax (Day 28 or 42) | 5631 | — |
| PF-07081532 60 mg Part ACmax (Day 1) | 1699 | — |
| Cmax (Day 28 or 42) | 12860 | — |
| PF-07081532 120 mg Part ACmax (Day 1) | 1548 | — |
| Cmax (Day 28 or 42) | 18520 | — |
| PF-07081532 180 mg Part BCmax (Day 1) | 1531 | — |
| Cmax (Day 28 or 42) | 35000 | — |
| PF-07081532 180 mg Part CCmax (Day 1) | 1587 | — |
| Cmax (Day 28 or 42) | 30600 | — |
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532
Time frame: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
Tmax
descriptive
Posted result
| Group | Value (median), hour | 95% CI |
|---|---|---|
| PF-07081532 10 mg Part ATmax (Day 1) | 1.00 | 1.00 – 2.00 |
| Tmax (Day 28 or 42) | 2.00 | 2.00 – 4.00 |
| PF-07081532 30 mg Part ATmax (Day 1) | 1.00 | 1.00 – 2.00 |
| Tmax (Day 28 or 42) | 4.00 | 1.00 – 12.00 |
| PF-07081532 60 mg Part ATmax (Day 1) | 2.00 | 1.00 – 4.00 |
| Tmax (Day 28 or 42) | 4.00 | 1.00 – 10.00 |
| PF-07081532 120 mg Part ATmax (Day 1) | 1.00 | 0.50 – 6.00 |
| Tmax (Day 28 or 42) | 4.00 | 4.00 – 12.00 |
| PF-07081532 180 mg Part BTmax (Day 1) | 1.50 | 0.50 – 4.00 |
| Tmax (Day 28 or 42) | 4.00 | 1.00 – 12.00 |
| PF-07081532 180 mg Part CTmax (Day 1) | 1.00 | 1.00 – 4.00 |
| Tmax (Day 28 or 42) | 8.00 | 6.00 – 12.00 |
Time Measured for the Plasma Concentration to Decrease by One-Half (t1/2) for PF-07081532
Time frame: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
Half-life
descriptive
Posted result
| Group | Value (mean), hour | 95% CI |
|---|---|---|
| PF-07081532 10 mg Part A | 26.50 | — |
| PF-07081532 30 mg Part A | 26.36 | — |
| PF-07081532 60 mg Part A | 23.68 | — |
| PF-07081532 120 mg Part A | 24.50 | — |
| PF-07081532 180 mg Part B | 20.70 | — |
| PF-07081532 180 mg Part C | 23.07 | — |
Cumulative Amount of Drug Recovered Unchanged in Urine Over 24 Hours (Ae24) for PF-07081532
Time frame:Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)
descriptive
Posted result
| Group | Value (geometric_mean), mg | 95% CI |
|---|---|---|
| PF-07081532 120 mg Part A | 0.1940 | — |
| PF-07081532 180 mg Part C | 0.1054 | — |
Percentage of Ae24 (Ae24%) for PF-07081532
Time frame:Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)
percent change from baseline, descriptive
Posted result
| Group | Value (geometric_mean), Percentage of Ae24 | 95% CI |
|---|---|---|
| PF-07081532 120 mg Part A | 0.1620 | — |
| PF-07081532 180 mg Part C | 0.05848 | — |
Renal Clearance (CLr) for PF-07081532
Time frame:Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)
descriptive
Posted result
| Group | Value (geometric_mean), liter per hour (L/hr) | 95% CI |
|---|---|---|
| PF-07081532 120 mg Part A | 0.0002690 | — |
| PF-07081532 180 mg Part C | 0.0001935 | — |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Diabetes, obesity & metabolism2024 Aug (month)PMID38751362doi:10.1111/dom.15643via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.