PF-06954522 for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must be taking: Metformin

Must not be taking: BCRP inhibitors, MDR1/P-gp inhibitors

Disqualifiers: Cardiovascular disease, Cancer, Pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF-06954522 in adult participants with inadequately controlled type 2 diabetes mellitus (T2DM) on metformin (Part A) and optionally in non-diabetic participants with obesity (Part B).

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 70 years old and cannot become pregnant or am a male.

I have type 2 diabetes and have been on a stable dose of metformin only for at least 2 months.

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria

I do not have a history of serious health issues that could affect my participation.

I have a significant health condition apart from my current diagnosis.

Use of prohibited medications, prior participation in specific trials, positive urine drug screen, abnormal blood pressure readings, abnormal ECG findings, abnormal clinical laboratory test results, abnormal fasting blood glucose levels, renal impairment, history of substance abuse, prior use of GLP-1R agonist, body weight limitations, hypersensitivity reactions, excessive tobacco/nicotine use, and exclusion of certain study personnel.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple escalating oral doses of PF-06954522 or placebo daily for up to 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Extension

An 8-period multiple-dose assessment of the effect of PF-06954522 on rosuvastatin, midazolam, and omeprazole PK in healthy adult participants

14 weeks

Treatment Details

Interventions

• PF-06954522

Trial Overview 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.

Participant Groups

Group I: Part C (Optional) Experimental Treatment 4 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 Treatment 2 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 A Experimental Treatment 2 Interventions

Multiple doses of PF 06954522 or placebo daily for up to 8 weeks in adult participants with T2DM in up to 7 cohorts.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University