PF-06954522 for Type 2 Diabetes

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment, PF-06954522, to assess its safety and tolerability in people with type 2 diabetes not well controlled on metformin. It also examines how the body absorbs and processes the drug. The trial includes different parts: one for individuals with type 2 diabetes, another for non-diabetic people with obesity, and a third optional part for healthy participants. Suitable candidates might include those with type 2 diabetes who have been on metformin with an HbA1c (a measure of blood sugar control) between 7.0% and 10.5%, or non-diabetic individuals with obesity. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

If you are participating in Part A of the trial and have type 2 diabetes, you must continue taking metformin as your only diabetes medication. For all parts, certain medications and supplements are prohibited before and during the trial, so you may need to stop taking some of your current medications. It's best to discuss your specific medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that PF-06954522 is likely to be safe for humans?

Research shows that PF-06954522, a new treatment for type 2 diabetes, is being tested for safety in people. In earlier studies, participants with type 2 diabetes received increasing doses of PF-06954522 to observe their body's response. The goal is to ensure the treatment is well-tolerated, meaning it should not cause major side effects.

Although the treatment remains in the early testing phase, these initial trials focus on determining the safety of PF-06954522. Researchers closely monitor for any side effects or negative reactions. Since PF-06954522 is in a Phase 1 trial, information about its safety in humans is limited. However, ongoing studies aim to identify and manage potential risks early.

Those considering joining a trial should consult a healthcare provider. They can offer personalized advice based on the latest research and individual health needs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PF-06954522 because it has the potential to offer a novel approach to managing Type 2 Diabetes (T2DM). Unlike standard treatments like metformin or insulin, PF-06954522 may work through a unique mechanism or pathway, providing an alternative for patients who may not respond well to existing options. Additionally, this drug is being tested in various populations, including those with obesity but no diabetes, which could broaden its potential use. This innovative approach has the potential to not only treat diabetes more effectively but also address related metabolic conditions.

What evidence suggests that PF-06954522 might be an effective treatment for type 2 diabetes?

Research shows that PF-06954522 could be a promising treatment for type 2 diabetes. This trial includes a treatment arm where adult participants with type 2 diabetes receive multiple doses of PF-06954522 or a placebo. This drug works similarly to GLP-1 agonists, which help lower blood sugar and support weight loss. People using similar treatments have experienced lower long-term blood sugar levels, reduced blood sugar after fasting, and weight loss. Early studies suggest that PF-06954522 might offer similar benefits. More research is needed to confirm these effects, but the initial results are encouraging for managing type 2 diabetes. ^{2 3 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

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

HbA1c criteria: For participants enrolling with T2DM: HbA1c ≥7.0% and ≤10.5% at screening (confirmed by a single repeat, if necessary). For participants enrolling as non-diabetic with obesity or healthy: HbA1c <6.5% at screening.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

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A Study to Learn How Different Amounts of PF-06954522 ...

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF- ...

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Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety ...

The Pfizer pipeline lists another GLP-1 agonist, PF-0695-4522, which is in Phase 1 testing for type 2 diabetes. ... A Phase 2 test of an oral ...

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pubmed.ncbi.nlm.nih.gov/37213102/

Efficacy and Safety of Oral Small Molecule Glucagon-Like ...

In adults with T2D, danuglipron reduced HbA1c, FPG, and body weight at week 16 compared with placebo, with a tolerability profile consistent with the mechanism ...

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PF-06954522 - Drug Targets, Indications, Patents

A Phase 1, Open-Label, Randomized, 5-Period, 6-Sequence, Crossover Study to Compare the Single-dose Pharmacokinetics of Immediate-Release and Modified-Release ...

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Pfizer Announces Topline Phase 2b Results of Oral GLP ...

Danuglipron demonstrated mean placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks ...

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A Study to Learn How Different Amounts of PF-06954522 Are ...

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating ...

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Pfizer Pipeline

PF-06954522. Glucagon-like peptide 1 receptor. (GLP-1R) agonist. Type 2 Diabetes Mellitus. Phase 1. New Molecular Entity. PF-07976016. GIPR ...