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Part C (Optional) for Type 2 Diabetes

Phase 1
Recruiting
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 part a: day -1, 1,14, 21 & 28. days 2, 4, 7, 10, 17, 20, 24 & 30. part a & b: day -1, 1, 28, 49 & 56. days 7, 14, 21, 35, 42, 57 & 58. part c: period 3 day 3 & period 5 day 28
Awards & highlights

Study Summary

"This trial aims to test the safety and effectiveness of different doses of PF-06954522 in adults with type 2 diabetes who are already taking metformin. It will also include non-diabetic

Who is the study for?
Adults aged 18-70 with type 2 diabetes on metformin or non-diabetic obese individuals can join this study. Participants must have a stable body weight and, for those with diabetes, an HbA1c level between 7.0% and 10.5%. Healthy participants without diabetes are also eligible for part of the study.Check my eligibility
What is being tested?
The trial is testing different doses of PF-06954522 to see how safe it is and how it affects the body in adults with type 2 diabetes or obesity. It will compare these effects against other medications like Rosuvastatin, Midazolam, Omeprazole, and a placebo.See study design
What are the potential side effects?
Possible side effects may include typical drug reactions such as digestive discomfort, changes in blood sugar levels, dizziness from Midazolam (a sedative), muscle pain from Rosuvastatin (for cholesterol), or headaches from Omeprazole (for acid reflux).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: day -1, 1,14, 21 & 28. days 2, 4, 7, 10, 17, 20, 24 & 30. part a & b: day -1, 1, 28, 49 & 56. days 7, 14, 21, 35, 42, 57 & 58. part c: period 3 day 3 & period 5 day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: day -1, 1,14, 21 & 28. days 2, 4, 7, 10, 17, 20, 24 & 30. part a & b: day -1, 1, 28, 49 & 56. days 7, 14, 21, 35, 42, 57 & 58. part c: period 3 day 3 & period 5 day 28 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 Reporting Adverse Events
Number of Participants With Change From Baseline in Physical Examination
Number of Participants With Clinically Significan Change From Baseline in Vital Signs
+3 more
Secondary outcome measures
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Maximum Observed Plasma Concentration (Cmax)
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C (Optional)Experimental Treatment4 Interventions
An 8-period multiple-dose assessment of the effect of PF-06954522 on rosuvastatin, midazolam, and omeprazole PK in healthy adult participants for up to 14 weeks in healthy adult participants.
Group II: Part B (Optional)Experimental Treatment2 Interventions
Multiple doses of PF 06954522 or placebo daily for up to 8 weeks in non-diabetic adult participants with obesity in up to 3 cohorts.
Group III: Part AExperimental Treatment2 Interventions
Multiple doses of PF 06954522 or placebo daily for up to 8 weeks in adult participants with T2DM in up to 7 cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910
PF-06954522
2023
Completed Phase 1
~30
Rosuvastatin
2019
Completed Phase 4
~3150
Placebo
1995
Completed Phase 3
~2670
Omeprazole
2006
Completed Phase 4
~940

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,860 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,078 Total Patients Enrolled

Frequently Asked Questions

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

Which individuals are eligible to partake in this research investigation?

"- BMI within defined range"

Answered by AI

Are individuals aged 60 and above being sought for participation in this study?

"Potential participants in this research must be above 18 years old but under the age of 70."

Answered by AI

What are the risks associated with choosing to enroll in Part C (Optional) for individuals seeking treatment?

"Our team at Power has evaluated Part C (Optional) to have a safety rating of 1 on the scale from 1 to 3. This assessment is due to the Phase 1 nature of the trial, indicating that there is restricted evidence supporting both safety and effectiveness."

Answered by AI

What is the current number of participants receiving treatment in this particular study?

"Indeed, as per clinicaltrials.gov data, this current investigation is actively seeking suitable candidates. Originally shared on February 20th, 2024, the latest update was made on March 5th of the same year. The study aims to enroll a total of 122 individuals across two designated sites."

Answered by AI

Are new participants currently being sought for this medical study?

"Affirmative. The details on clinicaltrials.gov specify that this investigation is presently enrolling subjects. Initially disclosed on February 20, 2024, the latest revision was made on March 5, 2024. Recruitment aims to enlist 122 participants from two designated sites."

Answered by AI

Who else is applying?

What site did they apply to?
Anaheim Clinical Trials, LLC
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Since the COVID-19 Pandemic I gained 50 pounds and I have tried using diet and exercise to lose weight but have been unable to lose weight.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus
2024. "A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06279234.
All > Anaheim > Paid Studies Ventura
~81 spots leftby Dec 2024
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