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PF-06954522 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 up to 5 years
Awards & highlights

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.
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.
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 ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
PF-06954522
2023
Completed Phase 1
~30
Midazolam
2018
Completed Phase 4
~1910
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
4,627 Previous Clinical Trials
14,284,804 Total Patients Enrolled
42 Trials studying Obesity
116,910 Patients Enrolled for Obesity
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,519 Previous Clinical Trials
11,459,284 Total Patients Enrolled
31 Trials studying Obesity
120,164 Patients Enrolled for Obesity
~37 spots leftby Dec 2024
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