PF-08653944 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the new treatment, PF-08653944, affects individuals who are obese or overweight with weight-related health conditions. Researchers aim to understand how the treatment works in the body and assess its safety through health tests, including blood tests. Participants will receive a single dose of the treatment and attend several clinic visits for health checks and to report any changes. The trial seeks adults who are overweight or obese and have related health issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that PF-08653944 has a safety profile similar to other treatments in its category, causing mostly mild to moderate side effects, primarily affecting the stomach and intestines, such as nausea or an upset stomach.
Research has explored its impact on weight loss, yielding positive results without unexpected safety issues. As this is an early-stage study, the primary goal is to understand the treatment's mechanism and ensure its safety for people. So far, evidence suggests it is well-tolerated in humans.
Prospective clinical trial participants should discuss any concerns with the study team. They will closely monitor health changes to ensure safety.12345Why do researchers think this study treatment might be promising for obesity?
Researchers are excited about PF-08653944 for obesity because it offers a novel approach to weight management. Unlike current treatments that often involve lifestyle changes, medication like orlistat to reduce fat absorption, or GLP-1 receptor agonists like semaglutide, PF-08653944 is administered as a single subcutaneous dose, potentially offering a more convenient and effective option. This investigational treatment is being explored for its unique delivery method to different body areas, such as the thigh, upper arm, and abdomen, which might optimize its efficacy and patient experience. The excitement stems from its potential to provide a simpler, yet powerful alternative to existing therapies, which typically require ongoing treatment and monitoring.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that PF-08653944, an injectable treatment, yields promising results for weight loss. Studies have found that participants lost 10% to 12.3% of their weight after 28 weeks with monthly injections. This treatment mimics a hormone that reduces hunger and helps manage blood sugar. Evidence suggests it can be as effective as other leading weight loss treatments, with the added convenience of fewer doses. Early results are positive, but ongoing research, including this trial where participants receive a single subcutaneous dose of PF-08653944 administered to different body areas, will continue to assess its safety and effectiveness.23678
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous dose of PF-08653944 administered to different injection sites
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood tests and vital signs checks
What Are the Treatments Tested in This Trial?
Interventions
- PF-08653944
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Japanese participants will receive a single SC dose of PF-08653944 on Day 1 administered to the abdomen.
Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the upper arm.
Participants will receive a single SC dose of PF-08653944 on Day 1 administered to the thigh.
Participants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1 administered to the abdomen.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
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
Pfizer's Ultra-Long-Acting Injectable GLP-1 RA Shows ...
Pfizer's Ultra-Long-Acting Injectable GLP-1 RA Shows Robust and Continued Weight Loss with Monthly Dosing in Phase 2b Trial · About PF-08653944 ( ...
2.
drugtopics.com
drugtopics.com/view/new-monthly-glp-1-data-shows-potential-in-obesity-management-with-monthly-dosingNew Monthly GLP-1 Data Shows Potential in Obesity ...
Pfizer's PF-08653944 achieved significant weight loss with monthly dosing, reducing dosing frequency while maintaining efficacy in the VESPER-3 ...
3.
biopharminternational.com
biopharminternational.com/view/pfizer-phase-iib-data-support-monthly-glp-1-dosing-for-obesityPfizer Phase IIb Data Support Monthly GLP-1 Dosing for ...
VESPER-3 trial demonstrated significant placebo-adjusted weight loss with monthly dosing of PF-08653944, supporting its potential as a viable ...
4.
fiercebiotech.com
fiercebiotech.com/biotech/pfizers-10b-monthly-glp-1-bet-generates-competitive-weight-loss-phase-2bPfizer links monthly GLP-1 to competitive weight loss in ...
Pfizer's monthly data fall into the range set by rivals, suggesting PF'3944 can provide competitive weight loss while freeing patients from the ...
5.
hcplive.com
hcplive.com/view/vesper-3-positive-results-of-long-term-glp-1-pf-3944-in-overweight-and-obesity-without-t2dVESPER-3: Positive Results of Long-Term GLP-1 PF'3944 ...
PF'3944 showed significant weight reduction in obese or overweight patients without type 2 diabetes in the VESPER-3 trial. The trial achieved ...
A Study to Learn About the Study Medicine (PF-08653944) ...
A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D). ClinicalTrials.gov ID NCT07400653.
A Study of PF-08653945 and PF-08653944 in Adults With ...
This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-learn-about-the-study-medicine-pf-08653944-in-people-with-obesity-or-overweight-and-typA Study to Learn About the Study Medicine (PF-08653944) in ...
The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight ...
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