AN INTERVENTIONAL PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO INVESTIGATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ASCENDING DOSES OF PF-08656795 IN ADULTS WITH OVERWEIGHT OR OBESITY
| Registry | NCT07876518 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, sequential, masking: double, basic science |
| Enrollment | 150 (Estimated) |
| Sponsor | Pfizer (Industry) |
| Conditions | Overweight and/or Obesity |
| Interventions | Placebo, PF-08656795 (Drug) |
| Dates | start 2026-10-30 (estimated), primary completion 2028-11-16 (estimated), completion 2028-11-16 (estimated), first posted 2026-10-15, last updated 2026-10-15 |
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All trials for Overweight and/or Obesity All trials of Placebo All trials of PF-08656795
This study will look at how different amounts of the study medicine, called PF-08656795, are tolerated and act in adults with overweight or obesity.
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.
The study is seeking participants who are:
* adults, 18 to 70 years of age (inclusive)
* have a body mass index (BMI) equal to, or more than 25 kilograms/meter square (kg/m2) up to 40 kg/m2.
* limited mild, stable long-term medical conditions are allowed as assessed by the study doctor.
People who want to join the study will first go through a screening period of up to 4 weeks. The study will look at how the study medicine is tolerated, including whether participants have any reactions. It will assess how they feel after receiving multiple doses. It will also measure the amounts of study medicine in the blood and urine over time.
Participants will take part in this study for about 24 to 40 weeks including treatment and follow-up period after the final dose. Treatment duration may vary depending on their assigned group.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PF-08656795 | Experimental | Drug: PF-08656795 | Participants will receive PF-08656795 once a month or less frequently |
| Placebo | Experimental | Drug: Placebo | Participants will receive placebo once a month or less frequently |
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
Inclusion: * Body mass index (BMI) ≥25 to ≤40 kg/m2; with stable body weight for ≥3 months prior to screening. * Participants are generally otherwise healthy but may have mild chronic conditions (eg, dyslipidemia or hypertension) Exclusion: \- Individuals with clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic disease, are not eligible to participate.