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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

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE ASCENDING ORAL DOSES OF PF-08642534 IN ADULTS WITH OBESITY

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07731139
Enrollment
120
Registered
2026-07-28
Start date
2026-07-28
Completion date
2027-04-21
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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.

Interventions

Participants will receive PF-08642534 QD (once a day)

DRUGPlacebo

Participants will receive matching placebo QD (once a day)

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Incidence of treatment emergent adverse events (TEAE)Baseline up to 8 weeks after last dose

Secondary

MeasureTime frame
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-086425340 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of PF-086425340 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose

Countries

United States

Contacts

CONTACTPfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026