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Purpose

The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood. The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week. About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective. People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Provision of signed and dated informed consent form (ICF) - Male or female adults, aged ≥18 years - Have a BMI at Screening of ≥27.0 kg/m2 - Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria - Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with: --Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin - Participants must be motivated and willing to: - Self-inject study medication (or be aided by caregiver if needed), - Perform finger-stick glucose monitoring as required. - Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria

  • Female who is breastfeeding, or who is pregnant - Unwilling or unable to follow contraceptive requirements - Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM. - Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening - Poorly controlled hypertension - Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening) - Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) intended to promote weight loss - Are receiving or have received within 3 months prior to screening chronic (>2 weeks or 14 days) systemic glucocorticoid therapy

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Arm 1 		Participants will receive PF-08653944 by Subcutaneous Injection.
  • Drug: PF-08653944
    By Subcutaneous Injection
    Other names:
    • MET097
Experimental
Treatment Arm 2 		Participants will receive PF-08653944 by Subcutaneous Injection.
  • Drug: PF-08653944
    By Subcutaneous Injection
    Other names:
    • MET097
Experimental
Treatment Arm 3 		Participants will receive PF-08653944 by Subcutaneous Injection.
  • Drug: PF-08653944
    By Subcutaneous Injection
    Other names:
    • MET097
Placebo Comparator
Placebo 		Participants will receive matching placebo by Subcutaneous Injection.
  • Other: Placebo
    By Subcutaneous Injection

Recruiting Locations

CenExel Anaheim Clinical Trials
Anaheim, California 92801

Alliance Research Institute
Canoga Park, California 91304

Core Healthcare Group
Cerritos, California 90703

CenExel CNS - Collaborative Neuroscience Research
Los Alamitos, California 90720

Cure Clinical Research
Orange, California 92866

CenExel CIT
Riverside, California 92506

CenExel Denver CO (Rocky Mountain Clinical Research)
Englewood, Colorado 80113

Miami Eye Institute
Hollywood, Florida 33024

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
Atlanta, Georgia 30329

CenExel iResearch, LLC
Decatur, Georgia 30030

CenExel iResearch, LLC
Savannah, Georgia 31405

Patient First Clinical Trials (PFCTRIALS)
Lutherville, Maryland 21093

DelRicht Research @ Command Family Medicine
Springfield, Missouri 65807

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

Eximia Research - NC, LLC
Raleigh, North Carolina 27607

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

CenExel Salt Lake City UT (JBR Clinical Research)
Salt Lake City, Utah 84107

Murray Vision Center PC
Salt Lake City, Utah 84107

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.