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

Registration

Registration

NCT05158244

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

TRIPLE

Status

COMPLETED

Enrollment

34

Start

2021-12-22

Primary completion

2022-06-15

Lead sponsor

Pfizer

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG:PF-07081532; DRUG:Placebo

Results posted

TRUE

Individual participant data sharing

NO

Registered primary outcomes

• Number of Participants With Treatment-emergent Adverse Events (All Causalities) [Baseline up to at least 28 days after last dose of study intervention (77 days)]
• Number of Participants With Treatment-emergent Adverse Events (Treatment Related) [Baseline up to at least 28 days after last dose of study intervention (77 days)]
• Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) [Baseline up to 7-14 days after last dose of study drug (maximum: 56 days)]
• Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data [Baseline up to 14 days after last dose of study intervention (maximum: 56 days)]
• Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data [Baseline up to 14 days after last dose of study intervention (maximum: 56 days)]