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NCT07400679CompletedPhase 1

A Study to Learn How the Study Medicine Called PF-08653944 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-08653944 WHEN ADMINISTERED ACROSS DIFFERENT INJECTION SITES IN ADULTS WITH OVERWEIGHT OR OBESITY

Source: ClinicalTrials.gov · Last updated 17 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
48 (actual)
First submitted
3 Feb 2026
Start date
4 Feb 2026
Primary completion date
2 Jul 2026
Lead sponsor
Pfizer
Diseases
Obesity
NCT number
NCT07400679

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 48
  • From 4 Feb 2026 to the primary completion date, 2 Jul 2026
  • 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-08653944 (formerly MET097) 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-08653944, GLP-1 receptor 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 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
New Haven Clinical Research Unit
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.