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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат PF-08653945
  Subcutaneous Injection

Первичные конечные точки

• Pharmacokinetics (PK): Area Under the Curve (AUC) of PF-08653945 [Срок оценки: Up to 57 days post-dose]
• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08653945 [Срок оценки: Up to 57 days post-dose]

Вторичные конечные точки (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 57 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Pfizer Clinical Research Unit - Brussels — Brussels

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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