CompletedPhase 1Results posted

Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

Lead sponsor

Pfizer

Asset

Lotiglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•HbA1c 7-10.5%

Primary endpoints

•Treatment-emergent AEs (any)•Laboratory Abnormalities•Vital Signs 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 IDNCT04305587

Org study IDC3991002

Timeline

Milestones

Study first posted2020-03-12actual

Study start2020-03-16actual

Primary completion2021-07-14actual

Study completion2021-07-14actual

Last update posted2024-02-05actual

Results first posted2024-02-05actual

Assets

Investigational agents

Lotiglipron

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

Key Inclusion Criteria for participants enrolling with T2DM:

•Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.

•HbA1c value between 7.0% and 10.5%, inclusive.

Key Exclusion Criterion for participants enrolling with T2DM:

-Type 1 Diabetes or secondary forms of diabetes.

Key Inclusion Criterion for participants enrolling with obesity:

-Obese (as indicated by screening BMI) non-diabetic adults.

Key Exclusion Criterion for participants enrolling with obesity:

--Type 1 or Type 2 Diabetes or secondary forms of diabetes.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

Number of Participants With Treatment Emergent Treatment-Related Adverse Events

Time frame:From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Participants	95% CI
Placebo Part ATreatment-related AEs	5	-
Treatment-related SAEs	0	-
PF-07081532 10 mg Part ATreatment-related AEs	2	-
Treatment-related SAEs	0	-
PF-07081532 30 mg Part ATreatment-related AEs	6	-
Treatment-related SAEs	1	-
PF-07081532 60 mg Part ATreatment-related AEs	6	-
Treatment-related SAEs	0	-
PF-07081532 120 mg Part ATreatment-related AEs	8	-
Treatment-related SAEs	0	-
Placebo Part BTreatment-related AEs	2	-
Treatment-related SAEs	0	-
PF-07081532 180 mg Part BTreatment-related AEs	11	-
Treatment-related SAEs	0	-
Placebo Part CTreatment-related AEs	2	-
Treatment-related SAEs	0	-
PF-07081532 180 mg Part CTreatment-related AEs	9	-
Treatment-related SAEs	0	-

Primary/protocol endpoint

Number of Participants With Laboratory Abnormalities

Time frame:From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)

descriptive, event

Posted result

Group	Participants	95% CI
Placebo Part AHDL Cholesterol (mg/dL) <0.8✕LLN	2	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	1	-
Calcitonin (pg/mL) >1.0✕ULN	0	-
Triglycerides (mg/dL) >1.3✕ULN	2	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	-
LDL Cholesterol (mg/dL) >1.2✕ULN	1	-
Urine Glucose ≥1	3	-
Urine Ketones ≥1	0	-
Urine Leukocyte Esterase ≥1	1	-
Urine Leukocytes (/high power field [HPF]) ≥20	1	-
Urine Hyaline Casts (/low power field [LPF]) >1	0	-
Urine Hemoglobin ≥1	1	-
Urine Nitrite ≥1	1	-
PF-07081532 10 mg Part AHDL Cholesterol (mg/dL) <0.8✕LLN	0	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	0	-
Calcitonin (pg/mL) >1.0✕ULN	0	-
Triglycerides (mg/dL) >1.3✕ULN	0	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	-
LDL Cholesterol (mg/dL) >1.2✕ULN	0	-
Urine Glucose ≥1	1	-
Urine Ketones ≥1	0	-
Urine Leukocyte Esterase ≥1	1	-
Urine Leukocytes (/high power field [HPF]) ≥20	1	-
Urine Hyaline Casts (/low power field [LPF]) >1	2	-
Urine Hemoglobin ≥1	1	-
Urine Nitrite ≥1	1	-
PF-07081532 30 mg Part AHDL Cholesterol (mg/dL) <0.8✕LLN	3	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	0	-
Calcitonin (pg/mL) >1.0✕ULN	0	-
Triglycerides (mg/dL) >1.3✕ULN	1	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	-
LDL Cholesterol (mg/dL) >1.2✕ULN	0	-
Urine Glucose ≥1	2	-
Urine Ketones ≥1	1	-
Urine Leukocyte Esterase ≥1	3	-
Urine Leukocytes (/high power field [HPF]) ≥20	2	-
Urine Hyaline Casts (/low power field [LPF]) >1	2	-
Urine Hemoglobin ≥1	1	-
Urine Nitrite ≥1	1	-
PF-07081532 60 mg Part AHDL Cholesterol (mg/dL) <0.8✕LLN	2	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	0	-
Calcitonin (pg/mL) >1.0✕ULN	1	-
Triglycerides (mg/dL) >1.3✕ULN	0	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	-
LDL Cholesterol (mg/dL) >1.2✕ULN	0	-
Urine Glucose ≥1	2	-
Urine Ketones ≥1	1	-
Urine Leukocyte Esterase ≥1	1	-
Urine Leukocytes (/high power field [HPF]) ≥20	0	-
Urine Hyaline Casts (/low power field [LPF]) >1	1	-
Urine Hemoglobin ≥1	0	-
Urine Nitrite ≥1	1	-
PF-07081532 120 mg Part AHDL Cholesterol (mg/dL) <0.8✕LLN	1	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	2	-
Calcitonin (pg/mL) >1.0✕ULN	2	-
Triglycerides (mg/dL) >1.3✕ULN	0	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	-
LDL Cholesterol (mg/dL) >1.2✕ULN	1	-
Urine Glucose ≥1	3	-
Urine Ketones ≥1	3	-
Urine Leukocyte Esterase ≥1	1	-
Urine Leukocytes (/high power field [HPF]) ≥20	0	-
Urine Hyaline Casts (/low power field [LPF]) >1	3	-
Urine Hemoglobin ≥1	0	-
Urine Nitrite ≥1	0	-
Placebo Part BHDL Cholesterol (mg/dL) <0.8✕LLN	1	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	0	-
Calcitonin (pg/mL) >1.0✕ULN	0	-
Triglycerides (mg/dL) >1.3✕ULN	0	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	-
LDL Cholesterol (mg/dL) >1.2✕ULN	0	-
Urine Glucose ≥1	0	-
Urine Ketones ≥1	0	-
Urine Leukocyte Esterase ≥1	0	-
Urine Leukocytes (/high power field [HPF]) ≥20	0	-
Urine Hyaline Casts (/low power field [LPF]) >1	0	-
Urine Hemoglobin ≥1	0	-
Urine Nitrite ≥1	0	-
PF-07081532 180 mg Part BHDL Cholesterol (mg/dL) <0.8✕LLN	1	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	0	-
Calcitonin (pg/mL) >1.0✕ULN	1	-
Triglycerides (mg/dL) >1.3✕ULN	0	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	2	-
LDL Cholesterol (mg/dL) >1.2✕ULN	2	-
Urine Glucose ≥1	0	-
Urine Ketones ≥1	3	-
Urine Leukocyte Esterase ≥1	2	-
Urine Leukocytes (/high power field [HPF]) ≥20	2	-
Urine Hyaline Casts (/low power field [LPF]) >1	1	-
Urine Hemoglobin ≥1	3	-
Urine Nitrite ≥1	0	-
Placebo Part CHDL Cholesterol (mg/dL) <0.8✕LLN	1	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	0	-
Calcitonin (pg/mL) >1.0✕ULN	0	-
Triglycerides (mg/dL) >1.3✕ULN	0	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	-
LDL Cholesterol (mg/dL) >1.2✕ULN	0	-
Urine Glucose ≥1	1	-
Urine Ketones ≥1	0	-
Urine Leukocyte Esterase ≥1	0	-
Urine Leukocytes (/high power field [HPF]) ≥20	0	-
Urine Hyaline Casts (/low power field [LPF]) >1	0	-
Urine Hemoglobin ≥1	0	-
Urine Nitrite ≥1	0	-
PF-07081532 180 mg Part CHDL Cholesterol (mg/dL) <0.8✕LLN	2	-
Bicarbonate (milliequivalents per liter [Meq/L]) <0.9✕LLN	0	-
Calcitonin (pg/mL) >1.0✕ULN	0	-
Triglycerides (mg/dL) >1.3✕ULN	0	-
Aspartate Aminotransferase (U/L) >3.0✕ULN	0	-
LDL Cholesterol (mg/dL) >1.2✕ULN	0	-
Urine Glucose ≥1	1	-
Urine Ketones ≥1	0	-
Urine Leukocyte Esterase ≥1	3	-
Urine Leukocytes (/high power field [HPF]) ≥20	0	-
Urine Hyaline Casts (/low power field [LPF]) >1	1	-
Urine Hemoglobin ≥1	0	-
Urine Nitrite ≥1	2	-

Primary/protocol endpoint

Number of Participants With Vital Signs Abnormalities

Time frame:From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)

threshold achievement, event

Posted result

Group	Participants	95% CI
Placebo Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	2	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	1	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	1	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	1	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	0	-
PF-07081532 10 mg Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg	1	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	1	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	1	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	2	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	1	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	1	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	0	-
PF-07081532 30 mg Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg	1	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	2	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	1	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	0	-
PF-07081532 60 mg Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	2	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	4	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	1	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	2	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	0	-
PF-07081532 120 mg Part ASupine Systolic Blood Pressure (mmHg) - Value <90mmHg	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	3	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	1	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	1	-
Placebo Part BSupine Systolic Blood Pressure (mmHg) - Value <90mmHg	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	0	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	0	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	0	-
PF-07081532 180 mg Part BSupine Systolic Blood Pressure (mmHg) - Value <90mmHg	1	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	3	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	0	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	1	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	3	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	0	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	0	-
Placebo Part CSupine Systolic Blood Pressure (mmHg) - Value <90mmHg	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	0	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	0	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	0	-
PF-07081532 180 mg Part CSupine Systolic Blood Pressure (mmHg) - Value <90mmHg	1	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg increase	0	-
Supine Systolic Blood Pressure (mmHg) - Change ≥ 30mmHg decrease	2	-
Supine Diastolic Blood Pressure (mmHg) - Value <50 mmHg	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg increase	0	-
Supine Diastolic Blood Pressure (mmHg) - Change ≥ 20mmHg decrease	0	-
Pulse Rate (bpm) - Value <40 bpm	0	-
Pulse Rate (bpm) - Value >120 bpm	0	-

Primary/protocol endpoint

Number of Participants With Abnormal Electrocardiogram (ECG)

Time frame:From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)

threshold achievement, event

Posted result

Group	Participants	95% CI
Placebo Part APR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	0	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	1	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	0	-
QTcF Interval (msec) -Change >60	0	-
PF-07081532 10 mg Part APR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	0	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	2	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	0	-
QTcF Interval (msec) -Change >60	0	-
PF-07081532 30 mg Part APR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	1	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	1	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	1	-
QTcF Interval (msec) -Change >60	0	-
PF-07081532 60 mg Part APR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	0	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	1	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	0	-
QTcF Interval (msec) -Change >60	0	-
PF-07081532 120 mg Part APR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	0	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	0	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	0	-
QTcF Interval (msec) -Change >60	0	-
Placebo Part BPR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	0	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	0	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	0	-
QTcF Interval (msec) -Change >60	0	-
PF-07081532 180 mg Part BPR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	0	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	0	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	2	-
QTcF Interval (msec) -Change >60	0	-
Placebo Part CPR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	0	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	0	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	0	-
QTcF Interval (msec) -Change >60	0	-
PF-07081532 180 mg Part CPR Interval (msec) - Value ≥300	0	-
PR Interval (msec) - %Change ≥ 25/50%	0	-
QRS Duration (msec) - Value ≥140	0	-
QRS Duration (msec) - %Change ≥ 50%	0	-
QTcF Interval (msec) - 450 < Value ≤ 480	0	-
QTcF Interval (msec) - 480 < Value ≤ 500	0	-
QTcF Interval (msec) - Value >500	0	-
QTcF Interval (msec) -30 < Change ≤ 60	0	-
QTcF Interval (msec) -Change >60	0	-

Secondary/protocol endpoint

Area Under the Curve From Time 0 to 24 Hours (AUC24) Post Dose for PF-07081532

Time frame:0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · nanogramhour/milliliter (nghr/mL)	95% CI
PF-07081532 10 mg Part AAUC24 (Day 1)	15530	-
AUC24 (Day 28 or 42)	26380	-
PF-07081532 30 mg Part AAUC24 (Day 1)	14430	-
AUC24 (Day 28 or 42)	78930	-
PF-07081532 60 mg Part AAUC24 (Day 1)	17220	-
AUC24 (Day 28 or 42)	177000	-
PF-07081532 120 mg Part AAUC24 (Day 1)	15100	-
AUC24 (Day 28 or 42)	265400	-
PF-07081532 180 mg Part BAUC24 (Day 1)	14340	-
AUC24 (Day 28 or 42)	521300	-
PF-07081532 180 mg Part CAUC24 (Day 1)	14560	-
AUC24 (Day 28 or 42)	496500	-

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) for PF-07081532

Time frame:0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · nanogram/milliliter (ng/mL)	95% CI
PF-07081532 10 mg Part ACmax (Day 1)	1599	-
Cmax (Day 28 or 42)	2263	-
PF-07081532 30 mg Part ACmax (Day 1)	1518	-
Cmax (Day 28 or 42)	5631	-
PF-07081532 60 mg Part ACmax (Day 1)	1699	-
Cmax (Day 28 or 42)	12860	-
PF-07081532 120 mg Part ACmax (Day 1)	1548	-
Cmax (Day 28 or 42)	18520	-
PF-07081532 180 mg Part BCmax (Day 1)	1531	-
Cmax (Day 28 or 42)	35000	-
PF-07081532 180 mg Part CCmax (Day 1)	1587	-
Cmax (Day 28 or 42)	30600	-

Secondary/protocol endpoint

Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-07081532

Time frame:0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Days 1 and 28 for Part A, on Days 1 and 42 for Part B and Part C

Tmax

descriptive

Posted result

Group	Median · hour	95% CI
PF-07081532 10 mg Part ATmax (Day 1)	1.00	1.00 - 2.00
Tmax (Day 28 or 42)	2.00	2.00 - 4.00
PF-07081532 30 mg Part ATmax (Day 1)	1.00	1.00 - 2.00
Tmax (Day 28 or 42)	4.00	1.00 - 12.00
PF-07081532 60 mg Part ATmax (Day 1)	2.00	1.00 - 4.00
Tmax (Day 28 or 42)	4.00	1.00 - 10.00
PF-07081532 120 mg Part ATmax (Day 1)	1.00	0.50 - 6.00
Tmax (Day 28 or 42)	4.00	4.00 - 12.00
PF-07081532 180 mg Part BTmax (Day 1)	1.50	0.50 - 4.00
Tmax (Day 28 or 42)	4.00	1.00 - 12.00
PF-07081532 180 mg Part CTmax (Day 1)	1.00	1.00 - 4.00
Tmax (Day 28 or 42)	8.00	6.00 - 12.00

Secondary/protocol endpoint

Time Measured for the Plasma Concentration to Decrease by One-Half (t1/2) for PF-07081532

Time frame:0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hours post-dose on Day 28 for Part A, on Day 42 for Part B and Part C

Half-life

descriptive

Posted result

Group	Mean · hour	95% CI
PF-07081532 10 mg Part A	26.50	-
PF-07081532 30 mg Part A	26.36	-
PF-07081532 60 mg Part A	23.68	-
PF-07081532 120 mg Part A	24.50	-
PF-07081532 180 mg Part B	20.70	-
PF-07081532 180 mg Part C	23.07	-

Secondary/protocol endpoint

Cumulative Amount of Drug Recovered Unchanged in Urine Over 24 Hours (Ae24) for PF-07081532

Time frame:Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)

descriptive

Posted result

Group	Geometric mean · mg	95% CI
PF-07081532 120 mg Part A	0.1940	-
PF-07081532 180 mg Part C	0.1054	-

Secondary/protocol endpoint

Percentage of Ae24 (Ae24%) for PF-07081532

Time frame:Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)

percent change from baseline, descriptive

Posted result

Group	Geometric mean · Percentage of Ae24	95% CI
PF-07081532 120 mg Part A	0.1620	-
PF-07081532 180 mg Part C	0.05848	-

Secondary/protocol endpoint

Renal Clearance (CLr) for PF-07081532

Time frame:Part A: Day 28 (0-24 hours). Part C : Day 42 (0-24 hours)

descriptive

Posted result

Group	Geometric mean · liter per hour (L/hr)	95% CI
PF-07081532 120 mg Part A	0.0002690	-
PF-07081532 180 mg Part C	0.0001935	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Once-daily oral small-molecule glucagon-like peptide-1 receptor agonist lotiglipron (PF-07081532) for type 2 diabetes and obesity: Two randomized, placebo-controlled, multiple-ascending-dose Phase 1 studies.
Diabetes, 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.