Trial Outcomes & Findings for Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus (NCT NCT05158244)
NCT ID: NCT05158244
Last Updated: 2024-08-12
Results Overview
An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE (SAE) was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. A severe AE was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling, limiting self-care activities of daily living. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period (starting after or on the first dose but before the last dose plus at least 28 days). AEs included all SAEs and non-SAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Baseline up to at least 28 days after last dose of study intervention (77 days)
Results posted on
2024-08-12
Participant Flow
Participant milestones
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
9
|
2
|
9
|
|
Overall Study
Received Treatment
|
6
|
8
|
9
|
2
|
9
|
|
Overall Study
COMPLETED
|
5
|
8
|
8
|
2
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by principal investigator due to protocol deviation
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=6 Participant
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=8 Participant
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participant
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
n=2 Participant
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
n=9 Participant
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
Total
n=34 Participant
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 Years
n=5 Participants
|
57.1 Years
n=7 Participants
|
54.4 Years
n=5 Participants
|
53.5 Years
n=4 Participants
|
49.0 Years
n=21 Participants
|
54.4 Years
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to at least 28 days after last dose of study intervention (77 days)Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE (SAE) was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. A severe AE was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling, limiting self-care activities of daily living. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period (starting after or on the first dose but before the last dose plus at least 28 days). AEs included all SAEs and non-SAEs.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=6 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
n=2 Participants
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
n=9 Participants
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (All Causalities)
Participants with AEs
|
5 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (All Causalities)
Participants with severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (All Causalities)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (All Causalities)
Participants with AEs leading to permanent discontinuation from study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to at least 28 days after last dose of study intervention (77 days)Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
A treatment related adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, considered related to the study drug (assessed by the investigator \[Yes/No\]). A serious AE (SAE) was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. A severe AE was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling, limiting self-care activities of daily living. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period (starting after or on the first dose but before the last dose plus at least 28 days). AEs included all SAEs and non-SAEs.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=6 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
n=2 Participants
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
n=9 Participants
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (Treatment Related)
Participants with AEs
|
5 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (Treatment Related)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (Treatment Related)
Participants with severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (Treatment Related)
Participants with AEs leading to permanent discontinuation from study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 7-14 days after last dose of study drug (maximum: 56 days)Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention and had at least 1 observation of the given laboratory test while on study treatment or during follow up. Here, "number analyzed" signifies number of participants evaluable for each category.
Following laboratory parameters analyzed for laboratory examination: hemoglobin (HGB); hematocrit; erythrocytes; erythrocytes (Ery.) mean corpuscular volume; Ery. mean corpuscular HGB; Ery. mean corpuscular HGB concentration; platelets; leukocytes; lymphocytes; neutrophils; basophils; eosinophils; monocytes; bilirubin; direct bilirubin; indirect bilirubin; aspartate aminotransferase; alanine aminotransferase; gamma glutamyl transferase; alkaline phosphatase; albumin; urea nitrogen; creatinine; urate; cholesterol; high density lipoprotein (HDL) cholesterol; sodium; potassium; chloride; calcium; bicarbonate; thyroxine; free; thyrotropin; creatine kinase; amylase; triacylglycerol lipase; triglycerides; pH; urine glucose; ketones; urine protein; urine hemoglobin; urobilinogen; urine bilirubin; nitrite; leukocyte esterase; urine erythrocytes; urine leukocytes; epithelial cells; casts; and bacteria.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=5 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
n=2 Participants
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
n=9 Participants
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
HGB (grams per deciliter [g/dL]) <0.8 x lower of limit of normal (LLN)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular Volume (10^-15 liters [L]) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Indirect Bilirubin (mg/dL) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Aspartate Aminotransferase (units per liter [U/L]) >3.0 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Alanine Aminotransferase (U/L) >3.0 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Gamma Glutamyl Transferase (U/L) >3.0 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Albumin (g/dL) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Sodium (milliequivalents per liter [mEq/L]) <0.95 x LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Sodium (milliequivalents per liter [mEq/L]) >1.05 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Potassium (mEq/L) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Chloride (mEq/L) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Calcium (mg/dL) >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Bicarbonate (mEq/L) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Creatine Kinase (U/L) >2.0 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Triacylglycerol Lipase (U/L) >1.5 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Triglycerides (mg/dL) >1.3 x ULN
|
1 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
pH >8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ketones >=1
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urine Protein >=1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urine hemoglobin >=1
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urobilinogen >=1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urine Bilirubin >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Nitrite >=1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Leukocyte Esterase >=1
|
0 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urine Leukocytes (/HPF) >=20
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hematocrit (%) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Erythrocytes (10^6/mm^3) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular Volume (10^-15 L) >1.1 x upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular HGB (picograms per cell [pg/cell]) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular HGB (pg/cell) >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Platelets (10^3/mm^3) <0.5 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Platelets (10^3/mm^3) >1.75 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Leukocytes (10^3/mm^3) <0.6 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Leukocytes (10^3/mm^3) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Lymphocytes (10^3/mm^3) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Lymphocytes (10^3/mm^3) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Neutrophils (10^3/mm^3) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Neutrophils (10^3/mm^3) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Basophils (10^3/mm^3) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Eosinophils (10^3/mm^3) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Monocytes (10^3/mm^3) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Bilirubin (milligrams per deciliter [mg/dL]) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Direct Bilirubin (mg/dL) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Alkaline Phosphatase (U/L) >3.0 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
High density lipoprotein (HDL) cholesterol (mg/dL) <32
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Albumin (g/dL) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urea Nitrogen (mg/dL) >1.3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Creatinine (mg/dL) >1.3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urate (mg/dL) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Cholesterol (mg/dL) >1.3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Potassium (mEq/L) >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Chloride (mEq/L) >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Calcium (mg/dL) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Bicarbonate (mEq/L) >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Thyroxine, Free (nanograms per deciliter [ng/dL]) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Thyroxine, Free (ng/dL) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Thyrotropin (micro-international units per milliliter [uIU/mL]) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Thyrotropin (uIU/mL) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Amylase (U/L) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
pH <4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urine glucose >=1
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urine Erythrocytes (per high power field [/HPF]) >=20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Epithelial Cells (per low power field [/LPF]) >=6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Casts (/LPF) >1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Bacteria (/HPF) >20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 14 days after last dose of study intervention (maximum: 56 days)Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Pre-specified categorical criteria included: supine systolic blood pressure (SBP) less than (\<) 90 millimeters of mercury (mmHg), supine SBP increase from baseline greater or equal to (\>=) 30 mmHg, supine SBP decrease from baseline \>=30 mmHg, supine diastolic blood pressure (DBP) \<50 mmHg, supine DBP increase from baseline \>=20 mmHg, supine DBP decrease from baseline \>=20 mmHg, supine pulse rate \<40 beats per minutes (bpm), and supine pulse rate greater than (\>) 120 bpm. Supine BP was 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.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=6 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
n=2 Participants
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
n=9 Participants
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Pulse rate >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Supine SBP <90 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Supine SBP increase from baseline >=30 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Supine SBP decrease from baseline >=30 mmHg
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Supine DBP <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Supine DBP increase from baseline >=20 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Supine DBP decrease from baseline >=20 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Pulse rate <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 14 days after last dose of study intervention (maximum: 56 days)Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Triplicate 12-lead ECGs were collected using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. Pre-specified categorical criteria included: PR interval greater or equal to 300 msec, PR interval %Chg\>=25/50% (%Chg\>=25/50% denotes baseline \>200 msec and \>=25% increase or baseline less than or equal to \[\<=\] 200 msec and \>=50% increase), QRS interval \>=140 msec, QRS interval increase from baseline \>=50%, QT interval corrected using Fridericia's formula (QTcF) \>450 msec and \<=480 msec, QTcF \>480 msec and \<=500 msec, QTcF \>500 msec, QTcF increase from baseline \>30 msec and \<=60 msec, and QTcF increase from baseline \>60 msec.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=6 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
n=2 Participants
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
n=9 Participants
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
PR interval >=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
PR interval %Chg>=25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
QTcF increase from baseline >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
QRS interval increase from baseline >=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
QRS interval >=140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
450 ms< QTcF<=480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
480 ms< QTcF<=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
QTcF >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
30 ms< QTcF increase from baseline <=60 msec
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42Population: All randomized participants that received at least 1 dose of PF-07081532, have at least 1 of the PK parameters of interest calculated and contributed to the summary statistics. Data collection was not planned for the placebo arms (Placebo \[T2DM\] and Placebo \[obesity\]).
AUC24 of PF-07081532 were determined by Linear/Log trapezoidal method on Study Day 1 and Study Day 42. On Study Day 1, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 20 mg, 40 mg, and 20 mg, respectively. On Study Day 42, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 60 mg, 80 mg, and 60 mg, respectively.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From 0 to 24 Hours (AUC24) of PF-07081532 on Day 1 and Day 42
Study Day 1
|
27000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 33
|
60280 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 23
|
27840 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
|
Area Under the Concentration-Time Profile From 0 to 24 Hours (AUC24) of PF-07081532 on Day 1 and Day 42
Study Day 42
|
141000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42
|
198400 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
146600 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 41
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42Population: All randomized participants that received at least 1 dose of PF-07081532, have at least 1 of the PK parameters of interest calculated and contributed to the summary statistics. Data collection was not planned for the placebo arms (Placebo \[T2DM\] and Placebo \[obesity\]).
Cmax of PF-07081532 were observed directly from data from time 0 to 24 hours on Study Day 1 and Study Day 42. On Study Day 1, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 20 mg, 40 mg, and 20 mg, respectively. On Study Day 42, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 60 mg, 80 mg, and 60 mg, respectively.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07081532 on Day 1 and Day 42
Study Day 1
|
2877 Nanograms per milliliter
Geometric Coefficient of Variation 19
|
5432 Nanograms per milliliter
Geometric Coefficient of Variation 31
|
2771 Nanograms per milliliter
Geometric Coefficient of Variation 25
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07081532 on Day 1 and Day 42
Study Day 42
|
9877 Nanograms per milliliter
Geometric Coefficient of Variation 29
|
14470 Nanograms per milliliter
Geometric Coefficient of Variation 30
|
11970 Nanograms per milliliter
Geometric Coefficient of Variation 38
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42Population: All randomized participants that received at least 1 dose of PF-07081532, have at least 1 of the PK parameters of interest calculated and contributed to the summary statistics. Data collection was not planned for the placebo arms (Placebo \[T2DM\] and Placebo \[obesity\]).
Tmax of PF-07081532 were observed directly from data as time of first occurrence on Study Day 1 and Study Day 42. On Study Day 1, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 20 mg, 40 mg, and 20 mg, respectively. On Study Day 42, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 60 mg, 80 mg, and 60 mg, respectively.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of PF-07081532 on Day 1 and Day 42
Study Day 42
|
2.00 Hours
Interval 1.42 to 6.0
|
5.00 Hours
Interval 0.5 to 10.0
|
2.00 Hours
Interval 1.0 to 2.0
|
—
|
—
|
|
Time to Reach Cmax (Tmax) of PF-07081532 on Day 1 and Day 42
Study Day 1
|
1.00 Hours
Interval 0.5 to 6.0
|
1.00 Hours
Interval 0.5 to 8.0
|
2.00 Hours
Interval 1.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 42Population: All randomized participants that received at least 1 dose of PF-07081532, have at least 1 of the PK parameters of interest calculated and contributed to the summary statistics for t1/2. Data collection was not planned for the placebo arms (Placebo \[T2DM\] and Placebo \[obesity\]).
t1/2 of PF-07081532 was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. On Study Day 42, participants in Arms of PF-07081532 20-60 mg (T2DM), PF-07081532 40-80 mg (T2DM), and PF-07081532 20-60 mg (obesity) received 60 mg, 80 mg, and 60 mg, respectively.
Outcome measures
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=8 Participants
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 Participants
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of PF-07081532 on Day 42
|
25.89 Hours
Standard Deviation 5.9188
|
26.04 Hours
Standard Deviation 5.7026
|
24.37 Hours
Standard Deviation 3.4366
|
—
|
—
|
Adverse Events
Placebo (Type 2 Diabetes Mellitus [T2DM])
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-07081532 20-60 mg (T2DM)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-07081532 40-80 mg (T2DM)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo (Obesity)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PF-07081532 20-60 mg (Obesity)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Type 2 Diabetes Mellitus [T2DM])
n=6 participants at risk
Adult participants with T2DM inadequately controlled on metformin received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg, 40, 60, or 80 mg) once daily (QD) for 6 weeks.
|
PF-07081532 20-60 mg (T2DM)
n=8 participants at risk
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
PF-07081532 40-80 mg (T2DM)
n=9 participants at risk
Adult participants with T2DM inadequately controlled on metformin received PF-07081532 40 mg QD for 4 weeks and then 80 mg QD for 2 weeks.
|
Placebo (Obesity)
n=2 participants at risk
Adult participants with obesity, without T2DM received matching placebo (number of placebo tablets were matched to the number of PF-07081532 tablets for 20 mg or 60 mg) QD for 6 weeks.
|
PF-07081532 20-60 mg (Obesity)
n=9 participants at risk
Adult participants with obesity, without T2DM received PF-07081532 20 mg QD for 4 weeks and then 60 mg QD for 2 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
4/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
3/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
3/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
37.5%
3/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
22.2%
2/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
3/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
3/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
44.4%
4/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Eructation
|
16.7%
1/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
62.5%
5/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
66.7%
6/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
44.4%
4/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
3/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Early satiety
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
22.2%
2/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Hordeolum
|
16.7%
1/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
16.7%
1/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
16.7%
1/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
4/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
3/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
44.4%
4/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
16.7%
1/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
3/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.1%
1/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/2 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/9 • Baseline up to 77 days
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER