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A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

Phase 1
Waitlist Available
Research Sponsored by Pfizer
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 pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on day 1
Awards & highlights
No Placebo-Only Group

Summary

This trial tests PF-07081532, a potential diabetes treatment, in people with kidney problems. Participants will take the medicine orally and stay in the clinic for a short period while researchers monitor how their bodies process it.

Eligible Conditions
  • Type 2 Diabetes
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
Maximum Observed Concentration (Cmax) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
Unbound AUCinf (AUCinf,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
+2 more
Secondary study objectives
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Defined Categorical Criteria
Number of Participants With Laboratory Test Abnormalities
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
+1 more

Side effects data

From 2021 Phase 1 trial • 66 Patients • NCT04305587
14%
Vaccination complication
14%
Dyspepsia
14%
Diarrhoea
14%
Decreased appetite
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
Participants with severe renal impairment will receive a single 20 mg dose of PF 07081532, administered orally
Group II: Group 3Experimental Treatment1 Intervention
Participants with moderate renal impairment will receive a single 20 mg dose of PF 07081532, administered orally
Group III: Group 2Experimental Treatment1 Intervention
Participants with mild renal impairment will receive a single 20 mg dose of PF 07081532, administered orally
Group IV: Group 1Experimental Treatment1 Intervention
Participants without renal impairment will receive a single 20 mg dose of PF 07081532, administered orally
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
4,675 Previous Clinical Trials
28,717,163 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,019 Total Patients Enrolled
~6 spots leftby Dec 2025
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