NCT07725809RecruitingPhase 1
A Study to Learn How the Study Medicine Called PF-08653945 is Taken up Into the Blood in Adults With Overweight or Obesity
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, PARALLEL GROUP STUDY TO ASSESS RELATIVE BIOAVAILABILITY OF PF-08653945 WHEN ADMINISTERED ACROSS DIFFERENT INJECTION SITES IN ADULTS WITH OVERWEIGHT OR OBESITY
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 57 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- 23 Jul 2026
- Primary completion date
- 13 Jan 2027
- Lead sponsor
- Pfizer
- Diseases
- Obesity
- NCT number
- NCT07725809
- EU CT number
- 2026-526334-67-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 57
- From 23 Jul 2026 to the primary completion date, 13 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect GI motility.
- Prior participation in any study involving PF-08653945 (formerly MET233) with at least one dose received.
Other illness
- 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.
- Known hypersensitivity to PF-08653945, amylin or calcitonin agonists, or any excipients.
Other
- Pregnant or breastfeeding women, or those planning pregnancy during the study.
- Acute gastrointestinal symptoms at screening or Day -1.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.