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
Pfizer
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DrugPF-08642534
Participants will receive PF-08642534 QD (once a day)
- DrugPlacebo
Participants will receive matching placebo QD (once a day)
Location
- Orange County Research CenterLake Forest, California