A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Overweight and/or Obesity; Overweight; Obesity; Drug Interaction

Treatments: Drug: PF-08653944; Drug: Acetaminophen

Study type: Interventional

Funder types: Industry

Identifiers

NCT07508241

C6491010

MET097-25-106 (Other Identifier)

Details and patient eligibility

About

This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity.

Participants will receive the study medicine for a short period, and doctors will measure how the medicine moves through the stomach and monitor safety. The goal is to better understand how this medicine works in the body and to check for any side effects.

The information from this study may help researchers plan future studies of this medicine.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG.
• Body mass index (BMI) 27-45 kg/m² and body weight >50 kg (110 lb).
• Participants with overweight or obesity

Exclusion criteria

• History or presence of clinically significant medical conditions, including but not limited to:

  --Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders.

• Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL.

• Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 6 patient groups

Period 1

Experimental group

Description:

Participants will receive a single oral dose of acetaminophen.

Treatment:

Drug: Acetaminophen

Period 2

Experimental group

Description:

Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.

Treatment:

Drug: Acetaminophen

Drug: PF-08653944

Period 3

Experimental group

Description:

Participants will receive SC dose of PF-0865394.

Treatment:

Drug: PF-08653944

Period 4

Experimental group

Description:

Participants will receive SC dose of PF-0865394.

Treatment:

Drug: PF-08653944

Period 5

Experimental group

Description:

Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.

Treatment:

Drug: Acetaminophen

Drug: PF-08653944

Period 6

Experimental group

Description:

Participants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen.

Treatment:

Drug: Acetaminophen

Drug: PF-08653944