Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

Purpose

This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.

Condition

  • Obesity and Overweight

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to <30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)

Exclusion Criteria

  • Have any form of diabetes - Have a self-reported body weight change > 5 kg (11 pounds) within 3 months prior to Screening - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) - History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MET097 Dose 1 		Participants will receive MET097 administered subcutaneously
  • Drug: MET097
    Once-weekly MET097 administered via subcutaneous injection
    Other names:
    • PF-08653944
Experimental
MET097 Dose 2 		Participants will receive MET097 administered subcutaneously
  • Drug: MET097
    Once-weekly MET097 administered via subcutaneous injection
    Other names:
    • PF-08653944
Experimental
MET097 Dose 3 		Participants will receive MET097 administered subcutaneously
  • Drug: MET097
    Once-weekly MET097 administered via subcutaneous injection
    Other names:
    • PF-08653944
Placebo Comparator
Placebo 		Once-weekly placebo administered via subcutaneous injection
  • Drug: Placebo
    Once-weekly placebo administered via subcutaneous injection

Recruiting Locations

Headlands Research
Scottsdale, Arizona 85260

Alliance Research Institute
Canoga Park, California 91304

Clinical Innovations, Inc dba CITrials
Riverside, California 92506

Peninsula Headlands LLC
Rolling Hills, California 90274

Collaborative Neuroscience Research, LLC
Torrance, California 90504

CenExcel Rocky Mountain Clinical Research, LLC
Englewood, Colorado 80113

Research Centers of America
Hollywood, Florida 33024

Future Medical Research (Civia Health)
Longwood, Florida 32750

Advanced Clinical Research
Miami, Florida 33156

Oviedo Medical Research
Oviedo, Florida 32765

CenExel FCR - ForCare Clinical Research
Tampa, Florida 33613

DelRicht Research @ Springer Wellness and Restorative Health
Atlanta, Georgia 30329

CenExel iResearch, LLC
Savannah, Georgia 31405

CenExel CBH Health
Gaithersburg, Maryland 20877

Clinical Research Professionals
Chesterfield, Missouri 63005

Quality Clinical Research Inc
Omaha, Nebraska 68114

Primary Care Research (Civia Health)
Papillion, Nebraska 68046

CenExel HRI - Hassman Research Institute
Marlton, New Jersey 08053

Forum Health Cary
Cary, North Carolina 27511

Eximia EquiHealth Research
Durham, North Carolina 27704

TMA Headlands LLC
Wilmington, North Carolina 28403

Summit Headlands LLC
Portland, Oregon 97210

Tribe Clinical Research, LLC
Greenville, South Carolina 29607

Tribe Clinical Research, LLC
Spartanburg, South Carolina 29301

Civia Health Goodlettsville
Goodlettsville, Tennessee 37072

Civia Health Nashville
La Vergne, Tennessee 37086

Forum Austin (Civia Health)
Austin, Texas 78578

GLRI El Paso Research
El Paso, Texas 79936

Dallas Clinical Research Center (Pillar Clinical Research)
Richardson, Texas 75080

Pantheon Clinical Research
Bountiful, Utah 84010

More Details

Status
Recruiting
Sponsor
Metsera, a wholly owned subsidiary of Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com