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

Registration

Registration

NCT04305587

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

66

Start

2020-03-16

Primary completion

2021-07-14

Lead sponsor

Pfizer

Conditions

Diabetes Mellitus Type 2

Interventions

DRUG:PF-07081532; OTHER:Placebo; DRUG:Clopidogrel

Results posted

TRUE

Individual participant data sharing

NO

Registered primary outcomes

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events [From the first dose up to 28-35 days after last administration of study intervention (that is a maximum of 63 days from first dose for Part A and a maximum of 77 days from first dose for Part B and Part C)]
• Number of Participants With Laboratory Abnormalities [From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)]
• Number of Participants With Vital Signs Abnormalities [From Baseline to 7-14 days following last dose administration (that is a maximum of 42 days from baseline for Part A and a maximum of 56 days from baseline for Part B and Part C)]
• Number of Participants With Abnormal Electrocardiogram (ECG) [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)]