Clinical trial

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

Active, not recruiting · Phase 3 · 5 countries · Registry ID NCT07400653

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight and/or Obesity, Overweight, Diabetes, Type 2, Type 2 Diabetes

Full registry criteria

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

Treatments and study arms

PF-08653944

Drug

By Subcutaneous Injection

Placebo

Other

By Subcutaneous Injection

Primary outcomes

Percent Change from baseline in body weightBaseline, Week 64

Study locations

188 locations were listed when this page was built. The first 40 are shown.

CEDIC🇦🇷 Buenos Aires, Argentina
Centro Medico Viamonte🇦🇷 Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Buenos Aires, Argentina
CIDIM🇦🇷 Córdoba, Argentina
Clinica Privada Velez Sarsfield🇦🇷 Córdoba, Argentina
Instituto de Investigaciones Clinicas Cordoba🇦🇷 Córdoba, Argentina
CIPADI - Centro Integral de Prevencion Y Atencion en Diabetes🇦🇷 Godoy Cruz, Argentina
Centro de Investigaciones Médicas Tucuman🇦🇷 San Miguel de Tucumán, Argentina
Instituto Medico Catamarca (IMEC)🇦🇷 Santa Fe, Argentina
MHAT Botevgrad🌐 Botevgrad, Bulgaria
Medical Center 4 Life EOOD, Burgas🌐 Burgas, Bulgaria
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)🌐 Dobrich, Bulgaria
Medical Center New Polyclinic Gabrovo Ltd.🌐 Gabrovo, Bulgaria
Medical Center Zdrave 1🌐 Kozloduy, Bulgaria
FutureMeds Plovdiv🌐 Plovdiv, Bulgaria
MHAT Sveta Karidad EAD🌐 Plovdiv, Bulgaria
Diagnostic Consultative Center Aleksandrovska🌐 Sofia, Bulgaria
Medical Center Hera EOOD🌐 Sofia, Bulgaria
Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD🌐 Stara Zagora, Bulgaria
Medical Center - Clinic Nova EOOD🌐 Varna, Bulgaria
Medical Centre Pratia Clinic EOOD🌐 Varna, Bulgaria
MC Nevromedics Ltd.🌐 Veliko Tarnovo, Bulgaria
Medical Center Berbatov🌐 Yambol, Bulgaria
Centricity Research Etobicoke Endocrinology🇨🇦 Etobicoke, Ontario, Canada
The Wharton Medical Clinic Clinical Trials Inc🇨🇦 Hamilton, Ontario, Canada
Centricity Research Mirabel Multispecialty (Centricity Research)🇨🇦 Mirabel, Quebec, Canada
LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)🇨🇦 Toronto, Ontario, Canada
Diacentrum Brandys n.L.🇨🇿 Brandys Nad Lebem, Czechia
Edumed s.r.o.🇨🇿 Náchod, Czechia
CCR Ostrava🇨🇿 Ostrava, Czechia
Pratia Pardubice🇨🇿 Pardubice, Czechia
Fakultní nemocnice Královské Vinohrady🇨🇿 Prague, Czechia
ResTrial s.r.o.🇨🇿 Prague, Czechia
Synexus/Trialmed Prague🇨🇿 Prague, Czechia
Diabetespraxis Dr. Braun🇩🇪 Berlin, Germany
FutureMeds Berlin🇩🇪 Berlin, Germany
Klinische Forschung Berlin-Mitte GmbH🇩🇪 Berlin, Germany
Velocity Clinical Research Germany🇩🇪 Berlin, Germany
Practice Dr. Kirsch and Colleague, Zentrum fur klinische Forschung🇩🇪 Cologne, Germany
Klinische Forschung Dresden GmbH / Pratia🇩🇪 Dresden, Germany