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PF-07081532 + Rybelsus for Type 2 Diabetes and PF-07081532 for Obesity
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.
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You have Type 2 diabetes that is not being well controlled by Metformin.Your fasting blood sugar level is below 126 mg/dL (7 mmol/L).You have a body mass index (BMI) of 23.0 kg/m2 (20.0 kg/m2 in Japan) or higher.Your blood sugar levels (measured by HbA1C) should be between 7% to 10% (53-86 mmol/mol).Your blood sugar levels, as measured by HbA1C, should not be higher than 6.4%.You have type 2 diabetes.You have type 2 diabetes that is not being well controlled with metformin.Your body mass index (BMI) is 30 or higher.Your fasting blood sugar level is less than or equal to 270 mg/dL (15 mmol/L) and you are not severely overweight.Have you been told by a doctor that you have Type 2 Diabetes?Are you between 18 and 75 years old?Is your HgbA1c level between 7.0% and 10.0%?Are you only taking Metformin for your Type 2 Diabetes right now?
- Group 1: PF-07081532 20 mg T2DM
- Group 2: PF-07081532 40 mg T2DM
- Group 3: PF-07081532 80 mg T2DM
- Group 4: PF-07081532 160 mg T2DM
- Group 5: PF-07081532 260 mg T2DM
- Group 6: Placebo T2DM
- Group 7: PF-07081532 80 mg Obesity
- Group 8: PF-07081532 140 mg Obesity
- Group 9: PF-07081532 200 mg Obesity (Option 1)
- Group 10: PF-07081532 200 mg Obesity (Option 2)
- Group 11: PF-07081532 260 mg Obesity
- Group 12: Rybelsus 14 mg T2DM
- Group 13: Placebo Obesity
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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, Floridaf Texas in Katy, Texas and Adult Medicine of Lake County in Mount Dora, Florida."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Most responsive sites:
- Tapia Internal Medicine: < 24 hours
- Sugar Lakes Family Practice: < 24 hours
- Chrysalis Clinical Research: < 24 hours
Typically responds via
Average response time
- < 2 Days
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