120 Participants NeededMy employer runs this trial

PF-08642534 for Obesity

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, PF-08642534, to determine its effects on people with obesity and their bodily reactions. The study will assess the drug's safety at various doses and its processing in the body. Participants will receive either the actual drug or a placebo (a harmless pill resembling the drug) once a day. Ideal candidates have a body mass index (BMI) between 30 and 40, are generally healthy, but may have mild conditions like high cholesterol or high blood pressure. Individuals with diabetes or major health issues such as heart or liver problems cannot participate. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new drug.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

In earlier studies, the drug PF-08642534, tested for obesity, was generally well-tolerated. Researchers examined how different doses affected people with obesity, focusing on safety and the drug's mechanism in the body. Although exact numbers on side effects are not yet available, the drug passed basic safety tests in the lab. This suggests manageable risks, but more information about its safety will emerge as future studies involve more participants.12345

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about PF-08642534 because it offers a novel approach to treating obesity. Unlike current treatments that often focus on suppressing appetite or altering metabolism through well-known pathways, PF-08642534 may target a new mechanism or pathway, potentially leading to more effective weight management. This unique action could provide an alternative for patients who do not respond well to existing options like lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as semaglutide. With obesity being a complex condition, having a treatment that works differently offers hope for better results and personalized care.

What evidence suggests that PF-08642534 might be an effective treatment for obesity?

Research has shown that PF-08642534 is a medication that can aid in weight loss. It influences hormones that regulate appetite, helping individuals feel fuller and consume less. In this trial, some participants will receive PF-08642534, while others will receive a placebo. Early data suggests that PF-08642534 may lead to weight loss comparable to well-known obesity medications. Although further research is necessary, it appears promising as a potential weight loss aid for individuals with obesity. Initial findings indicate it could become an important option for managing weight in the future.16789

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with obesity who are generally healthy. Participants must meet certain age and weight requirements. People with specific medical conditions or health issues will not be able to join.

Inclusion Criteria

Participants are generally otherwise healthy but may have mild chronic conditions such as dyslipidemia or hypertension
Body mass index (BMI) ≥30.0 and ≤40.0 kg/m² with stable body weight prior to screening

Exclusion Criteria

I have diabetes.
I have a serious heart, liver, kidney, digestive, or mental health disorder.
I have a condition that affects how my body absorbs or processes medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive either PF-08642534 or placebo once daily to assess safety, tolerability, and pharmacokinetics

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08642534

Trial Overview

The study is testing different doses of a new medicine called PF-08642534 compared to a placebo (inactive substance) in people with obesity, to see how safe it is and how the body processes it.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention
Group II: PF-08642534Experimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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