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

NCT07508241 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: C6491010MET097-25-106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax)

  To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.

  Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.

• Acetaminophen PK parameters: Area under the plasma concentration (AUC)

  To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.

  Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.

• Acetaminophen PK parameters: Time to Maximum concentration (Tmax)

  Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.

Secondary Outcomes (1)

• Number of participants with Treatment Emergent Adverse Events (TEAEs)

  First dose through study completion, approximately 11 Weeks post last dose.

Study Arms (6)

Period 1

EXPERIMENTAL

Participants will receive a single oral dose of acetaminophen.

Drug: Acetaminophen

Period 2

EXPERIMENTAL

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

Drug: PF-08653944; Drug: Acetaminophen

Period 3

EXPERIMENTAL

Participants will receive SC dose of PF-0865394.

Drug: PF-08653944

Period 4

EXPERIMENTAL

Participants will receive SC dose of PF-0865394.

Drug: PF-08653944

Period 5

EXPERIMENTAL

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

Drug: PF-08653944; Drug: Acetaminophen

Period 6

EXPERIMENTAL

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

Drug: PF-08653944; Drug: Acetaminophen

Interventions

PF-08653944 DRUG

Subcutaneous Injection

Also known as: MET097

Period 2; Period 3; Period 4; Period 5; Period 6

Acetaminophen DRUG

Oral suspension

Also known as: paracetamol

Period 1; Period 2; Period 5; Period 6

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): January 27, 2027
• Study Completion (Estimated): January 27, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)