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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PF-08642534, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug PF-08642534
Participants will receive PF-08642534 QD (once a day) - Drug Placebo
Participants will receive matching placebo QD (once a day)
Primary outcome measures
- Incidence of treatment emergent adverse events (TEAE) [Time frame: Baseline up to 8 weeks after last dose]
Secondary outcome measures (2)
- 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 [Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Orange County Research Center — Lake Forest
Identifiers
NCT: NCT07731139 · C6601003