Clinical trial NCT06717425: A Study to Learn About the Study Medicine Called PF-07976016 in Adults With Obesity
Official title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY OF PF-07976016 TO ASSESS SAFETY AND EFFICACY IN ADULT PARTICIPANTS WITH OBESITY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double-blind (investigator and participant), sponsor-open, placebo-controlled study.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percent change from baseline in body weight
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Number of participants with treatment emergent adverse events
timeFrame: From first dose (Day 1) up to 28-35 days after final dose, a total of approximately 21 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Saint Augustine
country: United States
facility: St Johns Center for Clinical Research
state: Florida
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Norman
country: United States
facility: Cornerstone Nutrition and Diabetes
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Austin
country: United States
facility: Elligo Clinical Research Center
state: Texas
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Saint George
country: United States
facility: Southwest Internal Medicine, PC
state: Utah
city: London
country: Canada
facility: Milestone Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: