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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 7-14 days after last administration of investigational product
Awards & highlights

Study Summary

This is a Phase 1, randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open study of PF-07081532. Study participants will receive the investigational product or placebo every day for 42 days. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled type 2 diabetes mellitus, on metformin and optionally in non-diabetic participants with obesity.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 7-14 days after last administration of investigational product
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 7-14 days after last administration of investigational product for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with clinically significant, abnormal 12-lead ECG parameters
Number of participants with clinically significant, abnormal safety laboratory tests
Number of participants with clinically significant, abnormal vital sign parameters
+1 more
Secondary outcome measures
Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration
Maximum Observed Plasma Concentration (Cmax) of PF-07081532
Plasma Decay Half-Life (t1/2) of PF-07081532
+1 more

Side effects data

From 2021 Phase 1 trial • 66 Patients • NCT04305587
50%
Early satiety
50%
Diarrhoea
25%
Hypoglycaemia
25%
Headache
25%
Abdominal pain
25%
Nausea
14%
Lacrimation increased
13%
Metabolic acidosis
13%
Dizziness
13%
Constipation
13%
Transaminases increased
13%
Dyspnoea
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%
0%
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

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
4,570 Previous Clinical Trials
10,910,406 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,520 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
2021. "Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05158244.
~10 spots leftby Apr 2025
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