Obesity
Conditions
Keywords
Obesity
Brief summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07976016) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-07976016) to those of participants who take placebo (a lookalike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight and how well they tolerate the study medicine.
Interventions
Taken once daily
Taken once daily
Sponsors
Study design
Intervention model description
This is a randomized, double-blind (investigator and participant), sponsor-open, placebo-controlled study.
Eligibility
Inclusion criteria
Key Inclusion Criteria: * Male or non-pregnant, non-breastfeeding female, 18 to 74 years of age at Visit 1 * Body Mass Index ≥30.0 kg/m2 at Visit 1, with stable body weight, defined as \<5 kg change in the 12 weeks before Visit 1 * Eligible and willing to receive required background medicine * Willing and able to comply with all study procedures Key
Exclusion criteria
* Any medical or psychiatric condition or laboratory abnormality, or recent serious illness or hospitalization, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study including diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes. * Use of any prohibited prior or concomitant medication(s) * Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in body weight | Baseline to Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment emergent adverse events | From first dose (Day 1) up to 28-35 days after final dose, a total of approximately 21 weeks |
Countries
Canada, Poland, United States
Contacts
Pfizer