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Clinical Trials in the USA / NCT07400653
Active, not recruiting Phase 3

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)

NCT07400653 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2026-02-24
Last updated
2026-09-08

Condition(s) studied

ObesityOverweight and/or ObesityOverweightDiabetes, Type 2Type 2 Diabetes

Investigational drug(s) / intervention(s)

PF-08653944Placebo

PF-08653944: By Subcutaneous Injection

Placebo: By Subcutaneous Injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (188)

FacilityCityRegionStatus
CenExel Anaheim Clinical Trials Anaheim California
Alliance Research Institute Canoga Park California
Core Healthcare Group Cerritos California
Retina Consultants of Orange County Fullerton California
CenExel CNS - Collaborative Neuroscience Research Los Alamitos California
DexaFit Los Alamitos Los Alamitos California
Retina Consultants of Orange County Los Alamitos California
Catalina Research Institute, LLC Montclair California
Cure Clinical Research Orange California
Rolling Oaks Radiology -Palms Oxnard California
Clinical Innovations, Inc dba CITrials Riverside California
Lundquist Institute for Biomedical Innovation at Harbor- UCLA Medical Center Torrance California
Access Eye Institute Westlake Village California
CenExcel Rocky Mountain Clinical Research, LLC Englewood Colorado
CenExel Denver CO (Rocky Mountain Clinical Research) Englewood Colorado
Neuro-Sight Vision Care Lakewood Colorado
AMR Clinical Fort Myers Florida
Pedro P. Ylisastigui, MD Fort Myers Florida
Private Practice Adjacent to For Eyes Optical Hialeah Florida
Miami Eye Institute Hollywood Florida
Research Centers of America Hollywood Florida
Future Medical Research (Civia Health) Longwood Florida
Advanced Clinical Research Miami Florida
Indago Research & Health Center, Inc Miami Lakes Florida
Optimal Research Sites, LLC Orange City Florida
Oviedo Medical Research Oviedo Florida
CenExel FCR - ForCare Clinical Research Tampa Florida
DelRicht Research Atlanta Georgia
CenExel iResearch, LLC Decatur Georgia
CenExel iResearch, LLC Savannah Georgia
Patient First Clinical Trials (PFCTRIALS) Lutherville Maryland
DelRicht Research Springfield Missouri
Upgrade Performance Institute Elkhorn Nebraska
Quality Clinical Research Inc Omaha Nebraska
Eye Consultants PC Omaha Nebraska
Primary clinical Research Papillion Nebraska
Hassman Research Institute Marlton New Jersey
Forum Health_Cary (Civia) Cary North Carolina
Eximia EquiHealth Research Durham North Carolina
Sahana Optometry PLLC dba Family Eye Wellness Holly Springs North Carolina

+ 148 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07400653 on ClinicalTrials.gov ↗ ← All trials in the USA