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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PF-08653944

    Drug

    Subcutaneous Injection

  • Acetaminophen

    Drug

    Oral suspension

Treatment groups

20 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Period 1Experimental treatment 1 intervention
Group B: Period 2Experimental treatment 2 interventions
Group C: Period 3Experimental treatment 1 intervention
Group D: Period 4Experimental treatment 1 intervention
Group E: Period 5Experimental treatment 2 interventions
Group F: Period 6Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
2

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.

Time frame
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
3

Acetaminophen PK parameters: Time to Maximum concentration (Tmax)

Time frame
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)

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

Other outcomes

Sponsors and contacts

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