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PF-07081532 + Rybelsus for Type 2 Diabetes and PF-07081532 for Obesity

Verified Trial
Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you been diagnosed with Type 2 Diabetes?
Are you 18-75 years old?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36 and 48
Awards & highlights

Study Summary

This trial will test if a new drug is safe & can help people with obesity & diabetes lose/manage weight. Participants will be monitored for up to 48 weeks.

Who is the study for?
This trial is for adults aged 18-75 with Type 2 Diabetes on metformin or those with obesity without diabetes. Diabetics should have HgbA1c levels between 7.0% - 10.0%. People not adequately controlled by Metformin, or with certain BMI and fasting plasma glucose (FPG) levels are excluded.Check my eligibility
What is being tested?
The study tests PF-07081532's safety and effectiveness in weight loss for obese individuals and blood sugar control for diabetics. Participants will receive either the active drug, a placebo, or Rybelsus if diabetic, over a period of up to 48 weeks with regular check-ins.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to diabetes medications such as digestive discomfort, low blood sugar episodes, potential allergic reactions, and other medication-specific effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Have you been told by a doctor that you have Type 2 Diabetes?
Select...
Are you between 18 and 75 years old?
Select...
Is your HgbA1c level between 7.0% and 10.0%?
Select...
Are you only taking Metformin for your Type 2 Diabetes right now?

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Placebo-adjusted, change from baseline in Hemoglobin A1c (HbA1c) at Week 32 in Type 2 Diabetes Mellitus (T2DM)
Obesity
Secondary outcome measures
Assessment of mental health as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) in Obesity
Placebo-adjusted, absolute change from baseline in waist circumference at Week 32 in Obesity
Obesity
+16 more

Side effects data

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

13Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PF-07081532 80 mg T2DMExperimental Treatment1 Intervention
PF-07081532 80 mg daily in T2DM
Group II: PF-07081532 80 mg ObesityExperimental Treatment1 Intervention
PF-07081532 80 mg daily in Obesity
Group III: PF-07081532 40 mg T2DMExperimental Treatment1 Intervention
PF-07081532 40 mg daily in T2DM
Group IV: PF-07081532 260 mg T2DMExperimental Treatment1 Intervention
PF-07081532 260 mg daily in T2DM
Group V: PF-07081532 260 mg ObesityExperimental Treatment1 Intervention
PF-07081532 260 mg daily in Obesity
Group VI: PF-07081532 200 mg Obesity (Option 2)Experimental Treatment1 Intervention
PF-07081532 200 mg daily in Obesity
Group VII: PF-07081532 200 mg Obesity (Option 1)Experimental Treatment1 Intervention
PF-07081532 200 mg daily in Obesity
Group VIII: PF-07081532 20 mg T2DMExperimental Treatment1 Intervention
PF-07081532 20 mg daily in T2DM
Group IX: PF-07081532 160 mg T2DMExperimental Treatment1 Intervention
PF-07081532 160 mg daily in T2DM
Group X: PF-07081532 140 mg ObesityExperimental Treatment1 Intervention
PF-07081532 140 mg daily in Obesity
Group XI: Rybelsus 14 mg T2DMActive Control1 Intervention
Semaglutide 14 mg daily in T2DM
Group XII: Placebo T2DMPlacebo Group1 Intervention
Placebo daily in T2DM
Group XIII: Placebo ObesityPlacebo Group1 Intervention
Placebo in Obesity
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
4,567 Previous Clinical Trials
10,911,093 Total Patients Enrolled
12 Trials studying Diabetes
107,251 Patients Enrolled for Diabetes
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,261 Total Patients Enrolled
1 Trials studying Diabetes
151 Patients Enrolled for Diabetes

Media Library

PF-07081532 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05579977 — Phase 2
Diabetes Research Study Groups: PF-07081532 20 mg T2DM, PF-07081532 40 mg T2DM, PF-07081532 80 mg T2DM, PF-07081532 160 mg T2DM, PF-07081532 260 mg T2DM, Placebo T2DM, PF-07081532 80 mg Obesity, PF-07081532 140 mg Obesity, PF-07081532 200 mg Obesity (Option 1), PF-07081532 200 mg Obesity (Option 2), PF-07081532 260 mg Obesity, Rybelsus 14 mg T2DM, Placebo Obesity
Diabetes Clinical Trial 2023: PF-07081532 Highlights & Side Effects. Trial Name: NCT05579977 — Phase 2
PF-07081532 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579977 — Phase 2
Diabetes Patient Testimony for trial: Trial Name: NCT05579977 — Phase 2

Frequently Asked Questions

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

How would the use of PF-07081532 20 mg T2DM impact patients’ health?

"Due to the fact that it is a Phase 2 trial, meaning there exists some evidence for safety but none regarding efficacy, our team at Power has assigned PF-07081532 20 mg T2DM an intermediate rating of 2 in terms of safety."

Answered by AI

Are individuals able to enroll in this investigation at this time?

"Affirmative. According to the clinicaltrials.gov website, this trial is actively seeking participants and was first published on November 8th 2022. Since then it has been revised up until October 27th 2022 with a target enrolment of 780 patients at 16 different hospital sites."

Answered by AI

How widespread is the implementation of this clinical trial?

"Patients are accepted at Medical Colleagues of Texas in Katy, Adult Medicine of Lake County from Mount Dora and Sugar Lakes Family Practice from Sugarland as well as 16 other participating medical sites."

Answered by AI

Is there an age restriction for participants of this investigation?

"To meet the requirements of this medical trial, candidates need to be aged between 18 and 75. There are 376 trials available for minors under the age of 18 whereas 1,418 studies target patients over 65 years old."

Answered by AI

How many participants can participate in this trial at its peak capacity?

"As part of the study's protocol, Pfizer must recruit 780 fitting patients. The trial will be administered at two sites - Medical Colleagues of Texas in Katy, Texas and Adult Medicine of Lake County in Mount Dora, Florida."

Answered by AI

Who would be the ideal participant for this clinical research endeavor?

"This study is open to 780 participants with a diagnosis of diabetes mellitus between the ages 18 and 75."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Florida
Other
Texas
How old are they?
18 - 65
65+
What site did they apply to?
Tapia Internal Medicine
Health Star Physician
Sugar Lakes Family Practice
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

Wanted to make money. Concerns with obesity. No puedo bajar de peso y. interested in reducing my a1c.
PatientReceived no prior treatments
Never tried drugs for diabetes.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long will the vest take ? What is the time frame for the study? Where would I need to go to do this trial?
PatientReceived no prior treatments
Do you have tests in the vicinity of Houston? How long is the trial? What is the compensation?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
  1. Tapia Internal Medicine: < 24 hours
  2. Sugar Lakes Family Practice: < 24 hours
  3. Chrysalis Clinical Research: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity
2022. "Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579977.
~323 spots leftby Apr 2025
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