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Clinical trial

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

ID
Name
C3991002
Description
This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional). The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.
Trial arms
Trial start
2020-03-16
Estimated PCD
2021-07-14
Trial end
2021-07-14
Status
Completed
Phase
Early phase I
Treatment
PF-07081532
Investigational Drug once daily for up to 42 days; multiple ascending dose design.
Arms:
Active T2DM, Placebo T2DM
Placebo
Placebo once daily for up to 42 days.
Arms:
Active Obesity, Placebo Obesity
Clopidogrel
Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
Arms:
Active Obesity, Placebo Obesity
Other names:
Plavix
Size
66
Primary endpoint
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)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double-blind (investigator- and participant-blind), sponsor-open', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}
Updated at
2024-02-05

1 organization

2 products

1 indication

Organization
Pfizer
Product
Clopidogrel
Indication
Diabetes Mellitus Type 2
Product
PF-07081532