NCT07725809 A Study to Learn How the Study Medicine Called PF-08653945 is Taken up Into the Blood in Adults With Overweight or Obesity
| NCT ID | NCT07725809 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pfizer |
| Condition | Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2026-07-23 |
| Primary Completion | 2027-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 57 participants in total. It began in 2026-07-23 with a primary completion date of 2027-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being done to learn how the study medicine affects the body. It will also assess how safe it is for people who take it. The researchers will use blood tests to measure how much medicine is in the blood. This study is seeking adults who are: * obese or overweight with weight-related health conditions, and * Meet health and other checks assessed by the study doctor. The study team will give a single dose of the study treatment at the clinic to the participants. At each study visit, blood samples will be collected and vital signs will be checked. The study team will also ask about any reactions or health changes. Vital signs are basic measurements that show how well the body is working. They help the study team quickly understand a participant's overall health. These usually include body temperature, heart rate, breathing rate, and blood pressure. The study involves multiple clinic visits at a study site over the length of the study. The information collected will help researchers understand how the study medicine works and whether it is safe.
Eligibility Criteria
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 (Optional Cohort 2) only: BMI of 22-45 kg/m2 and a total body weight \>50 kg (110 lb). NOTE: Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan. 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-08653945, amylin or calcitonin agonists, or any excipients. * Prior participation in any study involving PF-08653945 (formerly MET233) with at least one dose received.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07725809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07725809 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07725809 currently recruiting?
Yes, NCT07725809 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07725809 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT07725809 clinical trial?
NCT07725809 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 57 participants.