Actively Recruiting
A Phase 1 Open-Label Study to Investigate the Impact of PF-08653944 on Gastric Emptying in Adults With Overweight or Obesity
Led by Pfizer · Updated on 2026-04-23
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the medicine PF-08653944 affects the speed at which the stomach empties food after eating in adults who are overweight or have obesity. This Phase 1 open-label study aims to understand how the medicine moves through the stomach and to monitor its safety. The findings may help guide future research on this medicine. Participants will receive different doses of PF-08653944 through subcutaneous injections and may also receive a single oral dose of acetaminophen during several study periods. The study includes multiple experimental treatment periods where participants receive either PF-08653944 alone or combined with acetaminophen. During the study, researchers will measure acetaminophen levels in the blood to assess how the medicine affects gastric emptying and will monitor for any adverse effects from the treatments. The study safety and pharmacokinetics will be followed for about 11 weeks after the last dose. Participants' health will be checked through medical history, physical exams, lab tests, and ECGs throughout the study.
CONDITIONS
Brief Title
A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older at screening, male or female, generally healthy based on medical history, physical exam, lab tests, and ECG
- Body mass index (BMI) between 27 and 45 kg/m²
- Body weight greater than 50 kg (110 lb)
- Participants with overweight or obesity
You will not qualify if you...
- History or presence of significant medical conditions such as cardiovascular, liver, kidney, lung, endocrine, blood, nervous system, gastrointestinal (including pancreatitis or gallbladder disease), or serious psychiatric disorders
- Any form of diabetes, HbA1c 6.5% or higher, or fasting plasma glucose 126 mg/dL or higher
- Prior use of a GLP-1 receptor agonist within 90 days before first dose
- Previous participation in a study with PF-08653944
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 11 weeks
Participants receive single doses of study medicines PF-08653944 and/or acetaminophen across multiple periods to assess the effect on gastric emptying.
6 treatment periods with visits for dosing and assessments
Duration - Approximately 11 weeks post last dose
Participants are monitored for safety and treatment emergent adverse events after their last dose.
Regular follow-up visits during the post-treatment period
Trial Site Locations
Total: 1 location
1
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States, 06511
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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