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Active, Not Recruiting

NCT Number: NCT07400679

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Overweight Body Weight Healthy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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) with at least one dose received.

Treatment and study plan

PF-08653944

Drug

Solution for injection

Other names: MET097

Primary outcomes

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

    Time frame: Up to 85 days

    To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen

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

    Time frame: Up to 85 days

    To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 85 Days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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