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PF-07081532 for Type 2 Diabetes

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 baseline to day 29

Awards & highlights

Study Summary

This trial is testing a new drug to see how it is affected by renal impairment.

Eligible Conditions

Type 2 Diabetes
Kidney Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

AUCinfu= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for unbound drug

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

+4 more

Secondary outcome measures

Number of Participants With Treatment Emergent Clinically Significant Change from Baseline in Vital Signs Abnormalities

Number of Participants With Treatment Emergent Clinically Significant Clinical Laboratory Abnormalities

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

+1 more

Side effects data

From 2021 Phase 1 trial • 66 Patients • NCT04305587

50%

Early satiety

50%

Diarrhoea

25%

Headache

25%

Hypoglycaemia

25%

Abdominal pain

25%

Nausea

14%

Lacrimation increased

13%

Transaminases increased

13%

Metabolic acidosis

13%

Dizziness

13%

Dyspnoea

13%

Constipation

13%

Thrombocytopenia

13%

Hypokalaemia

13%

Leukocytosis

13%

Ocular hyperaemia

13%

Sepsis

13%

Vomiting

13%

Ovarian cyst

13%

Bandaemia

13%

Obstructive pancreatitis

13%

Cholelithiasis

13%

Acute kidney injury

13%

Hypotension

13%

Arteriosclerosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Part A

PF-07081532 30 mg Part A

PF-07081532 10 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,855 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,093,023 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project still require participants?

"Affirmative. Evidence from clinicaltrials.gov confirms that this research, which was first published on August 29th 2022 is open for enrollment. 32 individuals are expected to be recruited at 3 medical centres."

Answered by AI

How many individuals have volunteered to be involved in this research?

"Affirmative. Clinicaltrials.gov shows that this medical trial is currently enrolling suitable candidates, having been initially posted on August 29th 2022 and most recently updated on October 12th 2022. 32 individuals are needed to be recruited from 3 separate sites."

Answered by AI

Has PF-07081532 been authenticated by the Food & Drug Administration?

"Given the Phase 1 nature of this trial, there is minimal evidence to support both efficacy and safety. Therefore, our team at Power estimated PF-07081532's safety level at a score of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05510245.