PF-08653944 absorption in adults with overweight or obesity
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, PARALLEL GROUP STUDY TO ASSESS RELATIVE BIOAVAILABILITY OF PF-08653944 WHEN ADMINISTERED ACROSS DIFFERENT INJECTION SITES IN ADULTS WITH OVERWEIGHT OR OBESITY
Adults with overweight or obesity will receive a single dose of PF-08653944 to see how the medicine is absorbed into the blood and to check short-term safety.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07400679 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study gives a single dose of PF-08653944 to adults with overweight or obesity and collects blood samples and vital signs across clinic visits to measure how the drug is taken up and cleared. Investigators will run laboratory tests including calcitonin, amylase, and lipase and will monitor for adverse events because similar medicines have sometimes affected these markers. Participants undergo screening exams, ECGs, and labs to confirm they meet health criteria and must meet exclusion rules such as pregnancy or certain medical conditions. Dosing and all sample collection occur at a clinical research unit under medical supervision.
Who should consider this trial
Good fit: Adults 18 years or older who are overweight or obese (approximately BMI 27–45 kg/m2 and weight >50 kg) and who are otherwise healthy on screening exams are the intended participants.
Not a fit: People who are pregnant or breastfeeding, have significant medical conditions (including pancreatitis, gallbladder disease, serious cardiovascular, hepatic, renal, psychiatric, or neurologic disorders), or a personal/first-degree family history of medullary thyroid carcinoma or MEN2 are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If PF-08653944 shows favorable absorption and short-term safety, the results could help set appropriate dosing and guide further development for people with overweight or obesity.
How similar studies have performed: Single-dose pharmacokinetic and safety studies are a standard early step for new obesity medicines and have successfully guided dosing for other compounds, but findings for PF-08653944 itself are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Participants 18 years of age or older at Screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. * BMI of 27-45 kg/m2 ; and a total body weight \>50 kg (110 lb). * For Japanese participants only: BMI of 20-45 kg/m2 and a total body weight \>50 kg (110 lb) and must have 4 biological Japanese grandparents who were born in Japan. Key Exclusion Criteria: * Pregnant or breastfeeding women, or those planning pregnancy during the study. * Clinically significant medical conditions including hematologic, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis, gallbladder disease, clinically relevant gastric emptying disorders), cardiovascular, hepatic, psychiatric, neurologic, or severe allergic diseases. * Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC. * Active or recent suicidal ideation in the past year, suicidal behavior within the past 5 years, or any psychiatric condition that increases risk in the investigator's judgment. * Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect GI motility. * Acute gastrointestinal symptoms at screening or Day -1. * Known hypersensitivity to PF-08653944, GLP-1 receptor agonists, or any excipients. * Prior participation in any study involving PF-08653944 (formerly MET097) with at least one dose received.
Where this trial is running
New Haven, Connecticut
- New Haven Clinical Research Unit — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.