A Study to Learn About the Study Medicine Called PF-07976016 in Adults With Obesity

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Obesity

Treatments: Drug: PF-07976016; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06717425

C5541010

2024-513679-42-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 4 patient groups, including a placebo group

PF-07976016 Dose 1

Experimental group

Treatment:

Drug: PF-07976016

PF-07976016 Dose 2

Experimental group

Treatment:

Drug: PF-07976016

PF-07976016 Dose 3

Experimental group

Treatment:

Drug: PF-07976016

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo