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

NCT07731139 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: C6601003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events (TEAE)

  Baseline up to 8 weeks after last dose

Secondary Outcomes (2)

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

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

• Maximum Observed Plasma Concentration (Cmax) of PF-08642534

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

Study Arms (2)

Placebo

EXPERIMENTAL

Participants will receive matching placebo QD

Drug: Placebo

PF-08642534

EXPERIMENTAL

Participants will receive PF-08642534 QD

Drug: PF-08642534

Interventions

PF-08642534 DRUG

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

PF-08642534

Placebo DRUG

Participants will receive matching placebo QD (once a day)

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Related Links

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

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 28, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): April 21, 2027
• Study Completion (Estimated): April 21, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)