Active — Not RecruitingPhase 1

A Study to Learn How the Study Medicine Called PF-08653944 is Taken up Into the Blood in Adults With Overweight or Obesity

United States54 participantsStarted 2026-02-04

Plain-language summary

This study is being done to learn how the study medicine affects the body and how safe it is for people who take it. The researchers will look at a number of health tests, including blood tests such as calcitonin, amylase, and lipase, because similar medicines have sometimes caused changes in these tests. This study is seeking participants who are: * 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, vital signs will be checked, and the study team will 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944

Timeframe: Up to 85 days

PK: Maximum Observed Concentration (Cmax) of PF-08653944

Timeframe: Up to 85 days

Trial details

NCT IDNCT07400679

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-18

View on ClinicalTrials.gov More Overweight trials