PF-07081532 20 mg T2DM for Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetes Mellitus+1 More
PF-07081532 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study. Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.

Eligible Conditions
  • Diabetes Mellitus
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus

Study Objectives

2 Primary · 19 Secondary · Reporting Duration: week 36 and 48

Week 32
Proportion of participants achieving ≥10% body weight loss at Week 32 relative to baseline in Obesity
Proportion of participants achieving≥15% body weight loss at Week 32 relative to baseline in Obesity
Week 32 and 44
Assessment of mental health as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) in Obesity
Week 34, week 46
Electrocardiogram
Week 36, Week 48
To compare PF 07081532 to placebo in the number of participants with vital sign abnormalities
Week 36, week 48
To compare PF 07081532 to placebo in the number of participants reporting Hypoglycemia
To compare PF 07081532 to placebo in the number of participants with clinical laboratory abnormalities
baseline, week 32
Placebo-adjusted, absolute change from baseline in waist circumference at Week 32 in Obesity
Obesity
Placebo-adjusted, change from baseline in FPG at Week 32 in T2DM
Placebo-adjusted, change from baseline in HbA1C at Week 32 with Rybelsus in T2DM
Placebo-adjusted, change from baseline in Hemoglobin A1c (HbA1c) at Week 32 in Type 2 Diabetes Mellitus (T2DM)
Placebo-adjusted, change from baseline in Homeostatic Model Assessment for Insulin Resistance at Week 32 in Obesity
Obesity
Obesity
Placebo-adjusted, percent change from baseline in body weight at Week 32 in T2DM
Proportion of participants achieving ≥5% body weight loss at Week 32 relative to baseline in Obesity
week 32
Proportion of participants who achieve HbA1C <7% (<53 mmol/mol) at Week 32 in T2DM
week 36 and 48
To compare PF 07081532 to placebo in the number of participants reporting Adverse Events
week 36, week 48
To compare PF 07081532 to placebo in the number of participants reporting Adverse Events leading to discontinuation
To compare PF 07081532 to placebo in the number of participants reporting Serious Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Diabetes Mellitus

Trial Design

13 Treatment Groups

Rybelsus 14 mg T2DM
1 of 13
PF-07081532 20 mg T2DM
1 of 13
PF-07081532 160 mg T2DM
1 of 13
PF-07081532 80 mg T2DM
1 of 13
PF-07081532 40 mg T2DM
1 of 13
PF-07081532 140 mg Obesity
1 of 13
PF-07081532 200 mg Obesity (Option 1)
1 of 13
PF-07081532 260 mg T2DM
1 of 13
PF-07081532 260 mg Obesity
1 of 13
PF-07081532 200 mg Obesity (Option 2)
1 of 13
PF-07081532 80 mg Obesity
1 of 13
Placebo Obesity
1 of 13
Placebo T2DM
1 of 13
Active Control
Experimental Treatment
Non-Treatment Group

780 Total Participants · 13 Treatment Groups

Primary Treatment: PF-07081532 20 mg T2DM · Has Placebo Group · Phase 2

PF-07081532 20 mg T2DM
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 160 mg T2DM
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 80 mg T2DM
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 40 mg T2DM
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 140 mg Obesity
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 200 mg Obesity (Option 1)
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 260 mg T2DM
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 260 mg Obesity
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 200 mg Obesity (Option 2)
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
PF-07081532 80 mg Obesity
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
Placebo Obesity
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Rybelsus 14 mg T2DM
Drug
ActiveComparator Group · 1 Intervention: Rybelsus · Intervention Types: Drug
Placebo T2DM
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07081532
2020
Completed Phase 1
~130

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 36 and 48

Who is running the clinical trial?

PfizerLead Sponsor
4,260 Previous Clinical Trials
7,104,185 Total Patients Enrolled
112 Trials studying Diabetes Mellitus
54,569 Patients Enrolled for Diabetes Mellitus
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,248 Previous Clinical Trials
4,819,865 Total Patients Enrolled
76 Trials studying Diabetes Mellitus
40,967 Patients Enrolled for Diabetes Mellitus

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged 18 to 75 years old
You have Type 2 diabetes that is not adequately controlled by Metformin
You have a Hemoglobin A1C (HbA1C) of 7% - 10% (53-86 mmol/mol)
FPG is between 126 and 300 mg/dL (7 and 21 mmol/L).
Fasting plasma glucose (FPG) levels are less than or equal to 270 mg/dL (15 mmol/L).
HbA1C ≤6.4% (47 mmol/mol) is the threshold for diabetes.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: October 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Tennessee40.0%
Florida33.3%
Texas26.7%
How old are they?
18 - 6544.4%
65+55.6%
What site did they apply to?
Sugar Lakes Family Practice15.4%
Adult Medicine of Lake County30.8%
Health Star Physician38.5%
Other15.4%
What portion of applicants met pre-screening criteria?
Met criteria85.7%
Did not meet criteria14.3%
Why did patients apply to this trial?
  • "Tried to lose weight several times. No luck"
  • "I am supposed to be taking Trulicity, but I can't afford it."
  • "I tried januvia and synjardy and glimepride combination and my A1C was 10.8"
  • "I am taking metformin 1000 mg twice a day n glimipride still my A1c seems not satisfactory"
  • "I have tried many different medications with mixed results. Some I couldn't tolerate and others caused me to gain significant weight."
How many prior treatments have patients received?
042.9%
128.6%
214.3%
3+14.3%
What questions have other patients asked about this trial?
  • "What is the time frame for the study?"
  • "How long is the trial? What is the compensation?"

How responsive is this trial?

Typically responds via
Email25.0%
Phone Call75.0%
Most responsive sites:
  1. Sugar Lakes Family Practice: < 24 hours
  2. Adult Medicine of Lake County: < 24 hours
  3. Health Star Physician: < 24 hours
Average response time
  • < 2 Days