CompletedPhase 1Results posted
Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS
Lead sponsor
Asset
Lotiglipron
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
34
Study population
Obesity / overweight, Type 2 diabetes
Eligibility highlights
•BMI 24.5-45.5•HbA1c 7-10.5%
Primary endpoints
•Treatment-emergent Adverse Events (All Causalities)•Treatment-emergent Adverse Events (Treatment Related)•Laboratory Test Abnormalities
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT05158244
Org study IDC3991003
Timeline
Milestones
Study first posted2021-12-15actual
Study start2021-12-22actual
Primary completion2022-06-15actual
Study completion2022-06-15actual
Last update posted2024-08-12actual
Results first posted2024-08-12actual
Assets
Investigational agents
Who this study enrolls
Obesity / overweightType 2 diabetes
Who can enroll
Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Females of non childbearing potential;
•Patients with T2DM, inadequately controlled with metformin;
•HbA1c ≥7.0% to ≤10.5% (for T2DM); HbA1c <6.5% (for non-diabetic obese, if enrolled)
•Total body weight >50 kg (110 lbs)
•BMI ≥24.5 to ≤45.5 kg/m2 (T2DM), BMI >30.5 to ≤45.5 kg/m2 (for non-diabetic obese)
Exclusion criteria
•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease;
•Medical history of T2DM (for non-diabetic obese participants, if enrolled);
•Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
•Evidence or history of clinically significant cardiovascular disease;
•Any malignancy not considered cured;
•Acute pancreatitis or history of chronic pancreatitis;
•Acute gallbladder disease;
•Any condition possibly affecting drug absorption;
•Personal or family history of MTC or MEN2;
•Medical or psychiatric condition that may increase the risk of study participation;
•Any vaccination within the 1 week prior to admission to the CRU;
•Previous administration with an investigational drug within 30 days or 5 half-lives preceding first dose;
•Known prior participation in a trial involving PF-07081532;
•A positive urine drug screen at screening or admission;
•Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb;
•Positive COVID-19 test at screening or admission;
•Supine BP ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic);
•12-lead ECG clinically relevant abnormalities that may affect participant safety or interpretation of study results;
•Participants with ANY of the following abnormalities in clinical laboratory tests: *AST or ALT level ≥1.5x ULN;
-Total bilirubin level ≥1.5x ULN;
-TSH> ULN;
-Fasting C-peptide <0.8 ng/mL;
-Serum calcitonin > ULN;
-Amylase > ULN;
-Lipase > ULN;
-eGFR <60 mL/min/1.73m2 (per MDRD equation);
-FPG >270 mg/dL
•History of alcohol abuse, binge drinking and/or any illicit drug use or dependence within 6 months of Screening;
•Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing;
•History of sensitivity to heparin or heparin induced thrombocytopenia;
•Known intolerance to any GLP-1R agonist.
Endpoints (18)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
18 endpointsPrimary/registry result
Number of Participants With Treatment-emergent Adverse Events (All Causalities)
Time frame:Baseline up to at least 28 days after last dose of study intervention (77 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Placebo (Type 2 Diabetes Mellitus [T2DM])Participants with AEs | 5 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
| PF-07081532 20-60 mg (T2DM)Participants with AEs | 7 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
| PF-07081532 40-80 mg (T2DM)Participants with AEs | 6 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
| Placebo (Obesity)Participants with AEs | 0 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
| PF-07081532 20-60 mg (Obesity)Participants with AEs | 7 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
Primary/registry result
Number of Participants With Treatment-emergent Adverse Events (Treatment Related)
Time frame:Baseline up to at least 28 days after last dose of study intervention (77 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Placebo (Type 2 Diabetes Mellitus [T2DM])Participants with AEs | 5 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
| PF-07081532 20-60 mg (T2DM)Participants with AEs | 6 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
| PF-07081532 40-80 mg (T2DM)Participants with AEs | 6 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
| Placebo (Obesity)Participants with AEs | 0 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
| PF-07081532 20-60 mg (Obesity)Participants with AEs | 7 | - |
| Participants with SAEs | 0 | - |
| Participants with severe AEs | 0 | - |
| Participants with AEs leading to permanent discontinuation from study | 0 | - |
Primary/registry result
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame:Baseline up to 7-14 days after last dose of study drug (maximum: 56 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Placebo (Type 2 Diabetes Mellitus [T2DM])HGB (grams per deciliter [g/dL]) <0.8 x lower of limit of normal (LLN) | 1 | - |
| Hematocrit (%) <0.8 x LLN | 0 | - |
| Erythrocytes (10^6/mm^3) <0.8 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 liters [L]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 L) >1.1 x upper limit of normal (ULN) | 0 | - |
| Ery. Mean Corpuscular HGB (picograms per cell [pg/cell]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB (pg/cell) >1.1 x ULN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1 x ULN | 0 | - |
| Platelets (10^3/mm^3) <0.5 x LLN | 0 | - |
| Platelets (10^3/mm^3) >1.75 x ULN | 0 | - |
| Leukocytes (10^3/mm^3) <0.6 x LLN | 0 | - |
| Leukocytes (10^3/mm^3) >1.5 x ULN | 0 | - |
| Lymphocytes (10^3/mm^3) <0.8 x LLN | 0 | - |
| Lymphocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Neutrophils (10^3/mm^3) <0.8 x LLN | 0 | - |
| Neutrophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Basophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Eosinophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Monocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Bilirubin (milligrams per deciliter [mg/dL]) >1.5 x ULN | 0 | - |
| Direct Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Aspartate Aminotransferase (units per liter [U/L]) >3.0 x ULN | 0 | - |
| Alanine Aminotransferase (U/L) >3.0 x ULN | 0 | - |
| Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 | - |
| Alkaline Phosphatase (U/L) >3.0 x ULN | 0 | - |
| Albumin (g/dL) <0.8 x LLN | 0 | - |
| Albumin (g/dL) >1.2 x ULN | 0 | - |
| Urea Nitrogen (mg/dL) >1.3 x ULN | 0 | - |
| Creatinine (mg/dL) >1.3 x ULN | 0 | - |
| Urate (mg/dL) >1.2 x ULN | 0 | - |
| Cholesterol (mg/dL) >1.3 x ULN | 0 | - |
| High density lipoprotein (HDL) cholesterol (mg/dL) <32 | 1 | - |
| Sodium (milliequivalents per liter [mEq/L]) <0.95 x LLN | 0 | - |
| Sodium (milliequivalents per liter [mEq/L]) >1.05 x ULN | 0 | - |
| Potassium (mEq/L) <0.9 x LLN | 0 | - |
| Potassium (mEq/L) >1.1 x ULN | 0 | - |
| Chloride (mEq/L) <0.9 x LLN | 0 | - |
| Chloride (mEq/L) >1.1 x ULN | 0 | - |
| Calcium (mg/dL) <0.9 x LLN | 0 | - |
| Calcium (mg/dL) >1.1 x ULN | 0 | - |
| Bicarbonate (mEq/L) <0.9 x LLN | 0 | - |
| Bicarbonate (mEq/L) >1.1 x ULN | 0 | - |
| Thyroxine, Free (nanograms per deciliter [ng/dL]) <0.8 x LLN | 0 | - |
| Thyroxine, Free (ng/dL) >1.2 x ULN | 0 | - |
| Thyrotropin (micro-international units per milliliter [uIU/mL]) <0.8 x LLN | 0 | - |
| Thyrotropin (uIU/mL) >1.2 x ULN | 0 | - |
| Creatine Kinase (U/L) >2.0 x ULN | 0 | - |
| Amylase (U/L) >1.5 x ULN | 0 | - |
| Triacylglycerol Lipase (U/L) >1.5 x ULN | 0 | - |
| Triglycerides (mg/dL) >1.3 x ULN | 1 | - |
| pH <4.5 | 0 | - |
| pH >8 | 0 | - |
| Urine glucose >=1 | 4 | - |
| Ketones >=1 | 4 | - |
| Urine Protein >=1 | 0 | - |
| Urine hemoglobin >=1 | 1 | - |
| Urobilinogen >=1 | 0 | - |
| Urine Bilirubin >=1 | 0 | - |
| Nitrite >=1 | 0 | - |
| Leukocyte Esterase >=1 | 0 | - |
| Urine Erythrocytes (per high power field [/HPF]) >=20 | 0 | - |
| Urine Leukocytes (/HPF) >=20 | 0 | - |
| Epithelial Cells (per low power field [/LPF]) >=6 | 0 | - |
| Casts (/LPF) >1 | 0 | - |
| Bacteria (/HPF) >20 | 0 | - |
| PF-07081532 20-60 mg (T2DM)HGB (grams per deciliter [g/dL]) <0.8 x lower of limit of normal (LLN) | 0 | - |
| Hematocrit (%) <0.8 x LLN | 0 | - |
| Erythrocytes (10^6/mm^3) <0.8 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 liters [L]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 L) >1.1 x upper limit of normal (ULN) | 0 | - |
| Ery. Mean Corpuscular HGB (picograms per cell [pg/cell]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB (pg/cell) >1.1 x ULN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1 x ULN | 0 | - |
| Platelets (10^3/mm^3) <0.5 x LLN | 0 | - |
| Platelets (10^3/mm^3) >1.75 x ULN | 0 | - |
| Leukocytes (10^3/mm^3) <0.6 x LLN | 0 | - |
| Leukocytes (10^3/mm^3) >1.5 x ULN | 0 | - |
| Lymphocytes (10^3/mm^3) <0.8 x LLN | 0 | - |
| Lymphocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Neutrophils (10^3/mm^3) <0.8 x LLN | 0 | - |
| Neutrophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Basophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Eosinophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Monocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Bilirubin (milligrams per deciliter [mg/dL]) >1.5 x ULN | 0 | - |
| Direct Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Aspartate Aminotransferase (units per liter [U/L]) >3.0 x ULN | 0 | - |
| Alanine Aminotransferase (U/L) >3.0 x ULN | 1 | - |
| Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 | - |
| Alkaline Phosphatase (U/L) >3.0 x ULN | 0 | - |
| Albumin (g/dL) <0.8 x LLN | 0 | - |
| Albumin (g/dL) >1.2 x ULN | 0 | - |
| Urea Nitrogen (mg/dL) >1.3 x ULN | 0 | - |
| Creatinine (mg/dL) >1.3 x ULN | 0 | - |
| Urate (mg/dL) >1.2 x ULN | 0 | - |
| Cholesterol (mg/dL) >1.3 x ULN | 0 | - |
| High density lipoprotein (HDL) cholesterol (mg/dL) <32 | 2 | - |
| Sodium (milliequivalents per liter [mEq/L]) <0.95 x LLN | 1 | - |
| Sodium (milliequivalents per liter [mEq/L]) >1.05 x ULN | 0 | - |
| Potassium (mEq/L) <0.9 x LLN | 0 | - |
| Potassium (mEq/L) >1.1 x ULN | 0 | - |
| Chloride (mEq/L) <0.9 x LLN | 0 | - |
| Chloride (mEq/L) >1.1 x ULN | 0 | - |
| Calcium (mg/dL) <0.9 x LLN | 0 | - |
| Calcium (mg/dL) >1.1 x ULN | 0 | - |
| Bicarbonate (mEq/L) <0.9 x LLN | 0 | - |
| Bicarbonate (mEq/L) >1.1 x ULN | 0 | - |
| Thyroxine, Free (nanograms per deciliter [ng/dL]) <0.8 x LLN | 0 | - |
| Thyroxine, Free (ng/dL) >1.2 x ULN | 0 | - |
| Thyrotropin (micro-international units per milliliter [uIU/mL]) <0.8 x LLN | 0 | - |
| Thyrotropin (uIU/mL) >1.2 x ULN | 0 | - |
| Creatine Kinase (U/L) >2.0 x ULN | 0 | - |
| Amylase (U/L) >1.5 x ULN | 0 | - |
| Triacylglycerol Lipase (U/L) >1.5 x ULN | 1 | - |
| Triglycerides (mg/dL) >1.3 x ULN | 4 | - |
| pH <4.5 | 0 | - |
| pH >8 | 0 | - |
| Urine glucose >=1 | 3 | - |
| Ketones >=1 | 1 | - |
| Urine Protein >=1 | 1 | - |
| Urine hemoglobin >=1 | 3 | - |
| Urobilinogen >=1 | 1 | - |
| Urine Bilirubin >=1 | 0 | - |
| Nitrite >=1 | 1 | - |
| Leukocyte Esterase >=1 | 5 | - |
| Urine Erythrocytes (per high power field [/HPF]) >=20 | 0 | - |
| Urine Leukocytes (/HPF) >=20 | 1 | - |
| Epithelial Cells (per low power field [/LPF]) >=6 | 0 | - |
| Casts (/LPF) >1 | 0 | - |
| Bacteria (/HPF) >20 | 0 | - |
| PF-07081532 40-80 mg (T2DM)HGB (grams per deciliter [g/dL]) <0.8 x lower of limit of normal (LLN) | 0 | - |
| Hematocrit (%) <0.8 x LLN | 0 | - |
| Erythrocytes (10^6/mm^3) <0.8 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 liters [L]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 L) >1.1 x upper limit of normal (ULN) | 0 | - |
| Ery. Mean Corpuscular HGB (picograms per cell [pg/cell]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB (pg/cell) >1.1 x ULN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1 x ULN | 0 | - |
| Platelets (10^3/mm^3) <0.5 x LLN | 0 | - |
| Platelets (10^3/mm^3) >1.75 x ULN | 0 | - |
| Leukocytes (10^3/mm^3) <0.6 x LLN | 0 | - |
| Leukocytes (10^3/mm^3) >1.5 x ULN | 0 | - |
| Lymphocytes (10^3/mm^3) <0.8 x LLN | 0 | - |
| Lymphocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Neutrophils (10^3/mm^3) <0.8 x LLN | 0 | - |
| Neutrophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Basophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Eosinophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Monocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Bilirubin (milligrams per deciliter [mg/dL]) >1.5 x ULN | 0 | - |
| Direct Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Aspartate Aminotransferase (units per liter [U/L]) >3.0 x ULN | 0 | - |
| Alanine Aminotransferase (U/L) >3.0 x ULN | 0 | - |
| Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 | - |
| Alkaline Phosphatase (U/L) >3.0 x ULN | 0 | - |
| Albumin (g/dL) <0.8 x LLN | 0 | - |
| Albumin (g/dL) >1.2 x ULN | 0 | - |
| Urea Nitrogen (mg/dL) >1.3 x ULN | 0 | - |
| Creatinine (mg/dL) >1.3 x ULN | 0 | - |
| Urate (mg/dL) >1.2 x ULN | 0 | - |
| Cholesterol (mg/dL) >1.3 x ULN | 0 | - |
| High density lipoprotein (HDL) cholesterol (mg/dL) <32 | 3 | - |
| Sodium (milliequivalents per liter [mEq/L]) <0.95 x LLN | 0 | - |
| Sodium (milliequivalents per liter [mEq/L]) >1.05 x ULN | 0 | - |
| Potassium (mEq/L) <0.9 x LLN | 0 | - |
| Potassium (mEq/L) >1.1 x ULN | 0 | - |
| Chloride (mEq/L) <0.9 x LLN | 0 | - |
| Chloride (mEq/L) >1.1 x ULN | 0 | - |
| Calcium (mg/dL) <0.9 x LLN | 0 | - |
| Calcium (mg/dL) >1.1 x ULN | 0 | - |
| Bicarbonate (mEq/L) <0.9 x LLN | 0 | - |
| Bicarbonate (mEq/L) >1.1 x ULN | 0 | - |
| Thyroxine, Free (nanograms per deciliter [ng/dL]) <0.8 x LLN | 0 | - |
| Thyroxine, Free (ng/dL) >1.2 x ULN | 0 | - |
| Thyrotropin (micro-international units per milliliter [uIU/mL]) <0.8 x LLN | 0 | - |
| Thyrotropin (uIU/mL) >1.2 x ULN | 0 | - |
| Creatine Kinase (U/L) >2.0 x ULN | 0 | - |
| Amylase (U/L) >1.5 x ULN | 0 | - |
| Triacylglycerol Lipase (U/L) >1.5 x ULN | 0 | - |
| Triglycerides (mg/dL) >1.3 x ULN | 3 | - |
| pH <4.5 | 0 | - |
| pH >8 | 0 | - |
| Urine glucose >=1 | 3 | - |
| Ketones >=1 | 2 | - |
| Urine Protein >=1 | 0 | - |
| Urine hemoglobin >=1 | 3 | - |
| Urobilinogen >=1 | 0 | - |
| Urine Bilirubin >=1 | 0 | - |
| Nitrite >=1 | 1 | - |
| Leukocyte Esterase >=1 | 2 | - |
| Urine Erythrocytes (per high power field [/HPF]) >=20 | 0 | - |
| Urine Leukocytes (/HPF) >=20 | 0 | - |
| Epithelial Cells (per low power field [/LPF]) >=6 | 0 | - |
| Casts (/LPF) >1 | 0 | - |
| Bacteria (/HPF) >20 | 0 | - |
| Placebo (Obesity)HGB (grams per deciliter [g/dL]) <0.8 x lower of limit of normal (LLN) | 0 | - |
| Hematocrit (%) <0.8 x LLN | 0 | - |
| Erythrocytes (10^6/mm^3) <0.8 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 liters [L]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 L) >1.1 x upper limit of normal (ULN) | 0 | - |
| Ery. Mean Corpuscular HGB (picograms per cell [pg/cell]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB (pg/cell) >1.1 x ULN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1 x ULN | 0 | - |
| Platelets (10^3/mm^3) <0.5 x LLN | 0 | - |
| Platelets (10^3/mm^3) >1.75 x ULN | 0 | - |
| Leukocytes (10^3/mm^3) <0.6 x LLN | 0 | - |
| Leukocytes (10^3/mm^3) >1.5 x ULN | 0 | - |
| Lymphocytes (10^3/mm^3) <0.8 x LLN | 0 | - |
| Lymphocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Neutrophils (10^3/mm^3) <0.8 x LLN | 0 | - |
| Neutrophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Basophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Eosinophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Monocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Bilirubin (milligrams per deciliter [mg/dL]) >1.5 x ULN | 0 | - |
| Direct Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Aspartate Aminotransferase (units per liter [U/L]) >3.0 x ULN | 0 | - |
| Alanine Aminotransferase (U/L) >3.0 x ULN | 0 | - |
| Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 | - |
| Alkaline Phosphatase (U/L) >3.0 x ULN | 0 | - |
| Albumin (g/dL) <0.8 x LLN | 0 | - |
| Albumin (g/dL) >1.2 x ULN | 0 | - |
| Urea Nitrogen (mg/dL) >1.3 x ULN | 0 | - |
| Creatinine (mg/dL) >1.3 x ULN | 0 | - |
| Urate (mg/dL) >1.2 x ULN | 0 | - |
| Cholesterol (mg/dL) >1.3 x ULN | 0 | - |
| High density lipoprotein (HDL) cholesterol (mg/dL) <32 | 0 | - |
| Sodium (milliequivalents per liter [mEq/L]) <0.95 x LLN | 0 | - |
| Sodium (milliequivalents per liter [mEq/L]) >1.05 x ULN | 0 | - |
| Potassium (mEq/L) <0.9 x LLN | 0 | - |
| Potassium (mEq/L) >1.1 x ULN | 0 | - |
| Chloride (mEq/L) <0.9 x LLN | 0 | - |
| Chloride (mEq/L) >1.1 x ULN | 0 | - |
| Calcium (mg/dL) <0.9 x LLN | 0 | - |
| Calcium (mg/dL) >1.1 x ULN | 0 | - |
| Bicarbonate (mEq/L) <0.9 x LLN | 0 | - |
| Bicarbonate (mEq/L) >1.1 x ULN | 0 | - |
| Thyroxine, Free (nanograms per deciliter [ng/dL]) <0.8 x LLN | 0 | - |
| Thyroxine, Free (ng/dL) >1.2 x ULN | 0 | - |
| Thyrotropin (micro-international units per milliliter [uIU/mL]) <0.8 x LLN | 0 | - |
| Thyrotropin (uIU/mL) >1.2 x ULN | 0 | - |
| Amylase (U/L) >1.5 x ULN | 0 | - |
| Triacylglycerol Lipase (U/L) >1.5 x ULN | 0 | - |
| Triglycerides (mg/dL) >1.3 x ULN | 0 | - |
| pH <4.5 | 0 | - |
| pH >8 | 0 | - |
| Urine glucose >=1 | 0 | - |
| Ketones >=1 | 0 | - |
| Urine Protein >=1 | 0 | - |
| Urine hemoglobin >=1 | 0 | - |
| Urobilinogen >=1 | 0 | - |
| Urine Bilirubin >=1 | 0 | - |
| Nitrite >=1 | 0 | - |
| Leukocyte Esterase >=1 | 0 | - |
| Urine Erythrocytes (per high power field [/HPF]) >=20 | 0 | - |
| Urine Leukocytes (/HPF) >=20 | 0 | - |
| Epithelial Cells (per low power field [/LPF]) >=6 | 0 | - |
| Casts (/LPF) >1 | 0 | - |
| Bacteria (/HPF) >20 | 0 | - |
| PF-07081532 20-60 mg (Obesity)HGB (grams per deciliter [g/dL]) <0.8 x lower of limit of normal (LLN) | 0 | - |
| Hematocrit (%) <0.8 x LLN | 0 | - |
| Erythrocytes (10^6/mm^3) <0.8 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 liters [L]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular Volume (10^-15 L) >1.1 x upper limit of normal (ULN) | 0 | - |
| Ery. Mean Corpuscular HGB (picograms per cell [pg/cell]) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB (pg/cell) >1.1 x ULN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9 x LLN | 0 | - |
| Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1 x ULN | 0 | - |
| Platelets (10^3/mm^3) <0.5 x LLN | 0 | - |
| Platelets (10^3/mm^3) >1.75 x ULN | 0 | - |
| Leukocytes (10^3/mm^3) <0.6 x LLN | 0 | - |
| Leukocytes (10^3/mm^3) >1.5 x ULN | 0 | - |
| Lymphocytes (10^3/mm^3) <0.8 x LLN | 0 | - |
| Lymphocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Neutrophils (10^3/mm^3) <0.8 x LLN | 0 | - |
| Neutrophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Basophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Eosinophils (10^3/mm^3) >1.2 x ULN | 0 | - |
| Monocytes (10^3/mm^3) >1.2 x ULN | 0 | - |
| Bilirubin (milligrams per deciliter [mg/dL]) >1.5 x ULN | 0 | - |
| Direct Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 | - |
| Aspartate Aminotransferase (units per liter [U/L]) >3.0 x ULN | 0 | - |
| Alanine Aminotransferase (U/L) >3.0 x ULN | 0 | - |
| Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 | - |
| Alkaline Phosphatase (U/L) >3.0 x ULN | 0 | - |
| Albumin (g/dL) <0.8 x LLN | 0 | - |
| Albumin (g/dL) >1.2 x ULN | 0 | - |
| Urea Nitrogen (mg/dL) >1.3 x ULN | 0 | - |
| Creatinine (mg/dL) >1.3 x ULN | 0 | - |
| Urate (mg/dL) >1.2 x ULN | 0 | - |
| Cholesterol (mg/dL) >1.3 x ULN | 0 | - |
| High density lipoprotein (HDL) cholesterol (mg/dL) <32 | 6 | - |
| Sodium (milliequivalents per liter [mEq/L]) <0.95 x LLN | 0 | - |
| Sodium (milliequivalents per liter [mEq/L]) >1.05 x ULN | 0 | - |
| Potassium (mEq/L) <0.9 x LLN | 0 | - |
| Potassium (mEq/L) >1.1 x ULN | 0 | - |
| Chloride (mEq/L) <0.9 x LLN | 0 | - |
| Chloride (mEq/L) >1.1 x ULN | 0 | - |
| Calcium (mg/dL) <0.9 x LLN | 0 | - |
| Calcium (mg/dL) >1.1 x ULN | 0 | - |
| Bicarbonate (mEq/L) <0.9 x LLN | 0 | - |
| Bicarbonate (mEq/L) >1.1 x ULN | 1 | - |
| Thyroxine, Free (nanograms per deciliter [ng/dL]) <0.8 x LLN | 0 | - |
| Thyroxine, Free (ng/dL) >1.2 x ULN | 0 | - |
| Thyrotropin (micro-international units per milliliter [uIU/mL]) <0.8 x LLN | 0 | - |
| Thyrotropin (uIU/mL) >1.2 x ULN | 0 | - |
| Amylase (U/L) >1.5 x ULN | 0 | - |
| Triacylglycerol Lipase (U/L) >1.5 x ULN | 0 | - |
| Triglycerides (mg/dL) >1.3 x ULN | 2 | - |
| pH <4.5 | 0 | - |
| pH >8 | 0 | - |
| Urine glucose >=1 | 1 | - |
| Ketones >=1 | 3 | - |
| Urine Protein >=1 | 0 | - |
| Urine hemoglobin >=1 | 4 | - |
| Urobilinogen >=1 | 1 | - |
| Urine Bilirubin >=1 | 1 | - |
| Nitrite >=1 | 0 | - |
| Leukocyte Esterase >=1 | 7 | - |
| Urine Erythrocytes (per high power field [/HPF]) >=20 | 0 | - |
| Urine Leukocytes (/HPF) >=20 | 0 | - |
| Epithelial Cells (per low power field [/LPF]) >=6 | 0 | - |
| Casts (/LPF) >1 | 1 | - |
| Bacteria (/HPF) >20 | 0 | - |
Primary/registry result
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Time frame:Baseline up to 14 days after last dose of study intervention (maximum: 56 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Placebo (Type 2 Diabetes Mellitus [T2DM])Supine SBP <90 mmHg | 0 | - |
| Supine SBP increase from baseline >=30 mmHg | 0 | - |
| Supine SBP decrease from baseline >=30 mmHg | 1 | - |
| Supine DBP <50 mmHg | 0 | - |
| Supine DBP increase from baseline >=20 mmHg | 0 | - |
| Supine DBP decrease from baseline >=20 mmHg | 0 | - |
| Pulse rate <40 bpm | 0 | - |
| Pulse rate >120 bpm | 0 | - |
| PF-07081532 20-60 mg (T2DM)Supine SBP <90 mmHg | 1 | - |
| Supine SBP increase from baseline >=30 mmHg | 0 | - |
| Supine SBP decrease from baseline >=30 mmHg | 4 | - |
| Supine DBP <50 mmHg | 0 | - |
| Supine DBP increase from baseline >=20 mmHg | 0 | - |
| Supine DBP decrease from baseline >=20 mmHg | 0 | - |
| Pulse rate <40 bpm | 0 | - |
| Pulse rate >120 bpm | 0 | - |
| PF-07081532 40-80 mg (T2DM)Supine SBP <90 mmHg | 0 | - |
| Supine SBP increase from baseline >=30 mmHg | 1 | - |
| Supine SBP decrease from baseline >=30 mmHg | 2 | - |
| Supine DBP <50 mmHg | 0 | - |
| Supine DBP increase from baseline >=20 mmHg | 0 | - |
| Supine DBP decrease from baseline >=20 mmHg | 0 | - |
| Pulse rate <40 bpm | 0 | - |
| Pulse rate >120 bpm | 0 | - |
| Placebo (Obesity)Supine SBP <90 mmHg | 0 | - |
| Supine SBP increase from baseline >=30 mmHg | 0 | - |
| Supine SBP decrease from baseline >=30 mmHg | 1 | - |
| Supine DBP <50 mmHg | 0 | - |
| Supine DBP increase from baseline >=20 mmHg | 0 | - |
| Supine DBP decrease from baseline >=20 mmHg | 0 | - |
| Pulse rate <40 bpm | 0 | - |
| Pulse rate >120 bpm | 0 | - |
| PF-07081532 20-60 mg (Obesity)Supine SBP <90 mmHg | 0 | - |
| Supine SBP increase from baseline >=30 mmHg | 0 | - |
| Supine SBP decrease from baseline >=30 mmHg | 2 | - |
| Supine DBP <50 mmHg | 0 | - |
| Supine DBP increase from baseline >=20 mmHg | 0 | - |
| Supine DBP decrease from baseline >=20 mmHg | 0 | - |
| Pulse rate <40 bpm | 0 | - |
| Pulse rate >120 bpm | 0 | - |
Primary/registry result
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
Time frame:Baseline up to 14 days after last dose of study intervention (maximum: 56 days)
event count, event
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Placebo (Type 2 Diabetes Mellitus [T2DM])PR interval >=300 msec | 0 | - |
| PR interval %Chg>=25/50% | 0 | - |
| QRS interval >=140 msec | 0 | - |
| QRS interval increase from baseline >=50% | 0 | - |
| 450 ms< QTcF<=480 msec | 0 | - |
| 480 ms< QTcF<=500 msec | 0 | - |
| QTcF >500 msec | 0 | - |
| 30 ms< QTcF increase from baseline <=60 msec | 1 | - |
| QTcF increase from baseline >60 msec | 0 | - |
| PF-07081532 20-60 mg (T2DM)PR interval >=300 msec | 0 | - |
| PR interval %Chg>=25/50% | 0 | - |
| QRS interval >=140 msec | 0 | - |
| QRS interval increase from baseline >=50% | 0 | - |
| 450 ms< QTcF<=480 msec | 0 | - |
| 480 ms< QTcF<=500 msec | 0 | - |
| QTcF >500 msec | 0 | - |
| 30 ms< QTcF increase from baseline <=60 msec | 0 | - |
| QTcF increase from baseline >60 msec | 0 | - |
| PF-07081532 40-80 mg (T2DM)PR interval >=300 msec | 0 | - |
| PR interval %Chg>=25/50% | 0 | - |
| QRS interval >=140 msec | 0 | - |
| QRS interval increase from baseline >=50% | 0 | - |
| 450 ms< QTcF<=480 msec | 0 | - |
| 480 ms< QTcF<=500 msec | 0 | - |
| QTcF >500 msec | 0 | - |
| 30 ms< QTcF increase from baseline <=60 msec | 1 | - |
| QTcF increase from baseline >60 msec | 0 | - |
| Placebo (Obesity)PR interval >=300 msec | 0 | - |
| PR interval %Chg>=25/50% | 0 | - |
| QRS interval >=140 msec | 0 | - |
| QRS interval increase from baseline >=50% | 0 | - |
| 450 ms< QTcF<=480 msec | 0 | - |
| 480 ms< QTcF<=500 msec | 0 | - |
| QTcF >500 msec | 0 | - |
| 30 ms< QTcF increase from baseline <=60 msec | 0 | - |
| QTcF increase from baseline >60 msec | 0 | - |
| PF-07081532 20-60 mg (Obesity)PR interval >=300 msec | 0 | - |
| PR interval %Chg>=25/50% | 0 | - |
| QRS interval >=140 msec | 0 | - |
| QRS interval increase from baseline >=50% | 0 | - |
| 450 ms< QTcF<=480 msec | 0 | - |
| 480 ms< QTcF<=500 msec | 0 | - |
| QTcF >500 msec | 0 | - |
| 30 ms< QTcF increase from baseline <=60 msec | 0 | - |
| QTcF increase from baseline >60 msec | 0 | - |
Primary/protocol endpoint
Number of Participants With Treatment-emergent Adverse Events (All Causalities)
Time frame:Baseline up to at least 28 days after last dose of study intervention (77 days)
Treatment-emergent AEs (any)
event count, event
Primary/protocol endpoint
Number of Participants With Treatment-emergent Adverse Events (Treatment Related)
Time frame:Baseline up to at least 28 days after last dose of study intervention (77 days)
Treatment-emergent AEs (any)
event count, event
Primary/protocol endpoint
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Time frame:Baseline up to 7-14 days after last dose of study drug (maximum: 56 days)
descriptive, event
Primary/protocol endpoint
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
Time frame:Baseline up to 14 days after last dose of study intervention (maximum: 56 days)
threshold achievement, event
componentsSystolic BP, change, Diastolic BP, change, Heart rate, change
Primary/protocol endpoint
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
Time frame:Baseline up to 14 days after last dose of study intervention (maximum: 56 days)
threshold achievement, event
Secondary/registry result
Area Under the Concentration-Time Profile From 0 to 24 Hours (AUC24) of PF-07081532 on Day 1 and Day 42
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
concentration, descriptive
Posted result
| Group | Geometric mean · nanogram*hour per milliliter (ng*hr/mL) | 95% CI |
|---|---|---|
| PF-07081532 20-60 mg (T2DM)Study Day 1 | 27000 | - |
| Study Day 42 | 141000 | - |
| PF-07081532 40-80 mg (T2DM)Study Day 1 | 60280 | - |
| Study Day 42 | 198400 | - |
| PF-07081532 20-60 mg (Obesity)Study Day 1 | 27840 | - |
| Study Day 42 | 146600 | - |
Secondary/registry result
Maximum Observed Plasma Concentration (Cmax) of PF-07081532 on Day 1 and Day 42
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
concentration, descriptive
Posted result
| Group | Geometric mean · Nanograms per milliliter | 95% CI |
|---|---|---|
| PF-07081532 20-60 mg (T2DM)Study Day 1 | 2877 | - |
| Study Day 42 | 9877 | - |
| PF-07081532 40-80 mg (T2DM)Study Day 1 | 5432 | - |
| Study Day 42 | 14470 | - |
| PF-07081532 20-60 mg (Obesity)Study Day 1 | 2771 | - |
| Study Day 42 | 11970 | - |
Secondary/registry result
Time to Reach Cmax (Tmax) of PF-07081532 on Day 1 and Day 42
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
time to event, event
Posted result
| Group | Median · Hours | 95% CI |
|---|---|---|
| PF-07081532 20-60 mg (T2DM)Study Day 1 | 1.00 | 0.500 - 6.00 |
| Study Day 42 | 2.00 | 1.42 - 6.00 |
| PF-07081532 40-80 mg (T2DM)Study Day 1 | 1.00 | 0.500 - 8.00 |
| Study Day 42 | 5.00 | 0.5000 - 10.0 |
| PF-07081532 20-60 mg (Obesity)Study Day 1 | 2.00 | 1.00 - 4.00 |
| Study Day 42 | 2.00 | 1.00 - 2.00 |
Secondary/registry result
Terminal Half-life (t1/2) of PF-07081532 on Day 42
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 42
concentration, descriptive
Posted result
| Group | Mean · Hours | 95% CI |
|---|---|---|
| PF-07081532 20-60 mg (T2DM) | 25.89 | - |
| PF-07081532 40-80 mg (T2DM) | 26.04 | - |
| PF-07081532 20-60 mg (Obesity) | 24.37 | - |
Secondary/protocol endpoint
Area Under the Concentration-Time Profile From 0 to 24 Hours (AUC24) of PF-07081532 on Day 1 and Day 42
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
AUC₀-∞
concentration, descriptive
Secondary/protocol endpoint
Maximum Observed Plasma Concentration (Cmax) of PF-07081532 on Day 1 and Day 42
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
Cmax
concentration, descriptive
Secondary/protocol endpoint
Time to Reach Cmax (Tmax) of PF-07081532 on Day 1 and Day 42
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 1 and Study Day 42
Tmax
descriptive
Secondary/protocol endpoint
Terminal Half-life (t1/2) of PF-07081532 on Day 42
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Study Day 42
Half-life
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Diabetes, obesity & metabolism2024 Aug (month)PMID38751362doi:10.1111/dom.15643via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.