A Study to Learn How Different Amounts of the Study Medicine Called PF-08642534 Are Tolerated and Act in the Body of People Who Have Obesity

Phase 1RecruitingNCT07731139

Pfizer120 enrolled

Overview

This study will look at a study drug called PF-08642534 in people with obesity (have too much body weight) to see: if participants can take different amounts (doses) of the study drug in a safe way and how adults with obesity tolerate it, and how the body handles the study drug (for example, how the study drug is absorbed and removed from the body). People who want to join the study will first go through a screening period of up to 4 weeks. Doctors will check if each person meets the study conditions, including age, body weight, and general health. People with certain medical conditions will not be able to take part in the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

120

Conditions

Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion: * Body mass index (BMI) ≥30.0 and ≤40.0 kg/m², and with stable body weight prior to screening. * Participants are generally otherwise healthy but may have mild chronic conditions (eg, dyslipidemia or hypertension) Exclusion: \- Individuals with diabetes, significant cardiovascular, hepatic, renal, gastrointestinal, or psychiatric disorders, or conditions that may affect drug absorption or metabolism, are not eligible to participate.

Outcomes

Primary Outcomes

Incidence of treatment emergent adverse events (TEAE)

Time frame: Baseline up to 8 weeks after last dose

Secondary Outcomes

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-08642534

Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose

Maximum Observed Plasma Concentration (Cmax) of PF-08642534