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Not yet recruiting NCT07725809

A Study to Learn How the Study Medicine Called PF-08653945 is Taken up Into the Blood in Adults With Overweight or Obesity

Phase I Interventional Overweight Obesity Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PF-08653945.
Who it may be relevant to
Registry conditions: Overweight, Obesity, Healthy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug PF-08653945
    Subcutaneous Injection

Primary outcome measures

  • Pharmacokinetics (PK): Area Under the Curve (AUC) of PF-08653945 [Time frame: Up to 57 days post-dose]
  • Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08653945 [Time frame: Up to 57 days post-dose]
Secondary outcome measures (1)
  • Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 57 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Pfizer Clinical Research Unit - Brussels — Brussels

Identifiers

NCT: NCT07725809 · C6501003 · 2026-526334-67-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗