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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on study day 1 and study day 42
Summary
This trial tests a new drug called PF-07081532 to see if it is safe and how it behaves in the body. It targets people with type 2 diabetes who are not well-controlled on their current medication and some people with obesity. Participants will take the drug daily for several weeks while researchers monitor its effects.
Eligible Conditions
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on study day 1 and study day 42
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post dose on study day 1 and study day 42
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Number of Participants With Pre-specified Categorical Post-Baseline Electrocardiogram (ECG) Data
Number of Participants With Pre-specified Categorical Post-Baseline Vital Signs Data
+2 moreSecondary study objectives
Area Under the Concentration-Time Profile From 0 to 24 Hours (AUC24) of PF-07081532 on Day 1 and Day 42
Maximum Observed Plasma Concentration (Cmax) of PF-07081532 on Day 1 and Day 42
Terminal Half-life (t1/2) of PF-07081532 on Day 42
+1 moreSide effects data
From 2021 Phase 1 trial • 66 Patients • NCT0430558714%
Dyspepsia
14%
Diarrhoea
14%
Decreased appetite
14%
Vaccination complication
14%
Dermatitis contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-07081532 10 mg Part A
Placebo Part A
PF-07081532 30 mg Part A
PF-07081532 60 mg Part A
PF-07081532 120 mg Part A
Placebo Part B
PF-07081532 180 mg Part B
Placebo Part C
PF-07081532 180 mg Part C
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-07081532Experimental Treatment1 Intervention
multiple dosing, once-daily for 42 days
Group II: PlaceboPlacebo Group1 Intervention
multiple dosing, once-daily for 42 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07081532
2022
Completed Phase 1
~170
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,661 Previous Clinical Trials
17,844,955 Total Patients Enrolled
12 Trials studying Diabetes
107,251 Patients Enrolled for Diabetes
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,886,111 Total Patients Enrolled
1 Trials studying Diabetes
151 Patients Enrolled for Diabetes
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