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COMPLETED
NCT06323174
PHASE3

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

189

Start Date

2024-03-19

Completion Date

2025-12-22

Last Updated

2026-09-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Cagrilintide

Participants will receive once-weekly cagrilintide subcutaneously.

DRUG

Semaglutide

Participants will receive once-weekly semaglutide subcutaneously.

DRUG

Placebo

Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.

Locations (50)

Nat Res Inst Huntington Park

Huntington Park, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Southern California Dermatology

Santa Ana, California, United States

Encore Medical Research LLC

Hollywood, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

Encore Medical Research of Weston

Weston, Florida, United States

Alliance for Multispec Res

Newton, Kansas, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Arcturus HC PLC Troy Med Res

Troy, Michigan, United States

Southgate Medical Group, LLP

West Seneca, New York, United States

Summit Research Network Oregon Inc.

Portland, Oregon, United States

Holston Medical Group

Kingsport, Tennessee, United States

Amarillo Medical Specialists

Amarillo, Texas, United States

Elligo Clin Res Centre

Austin, Texas, United States

Headlands Research Brownsville

Brownsville, Texas, United States

Velocity Clinical Res-Dallas

Dallas, Texas, United States

Northeast Clinical Research of San Antonio

San Antonio, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Sugar Lakes Family Practice PA

Sugar Land, Texas, United States

Valley Diab. & Endo Comp Ctr

Weslaco, Texas, United States

TPMG Clinical Research

Newport News, Virginia, United States

Chinese People's Liberation Army General Hospital-Endocrinology

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, China

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, China

Jinan Central Hospital

Ji'Nan, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Belinus Bt.

Debrecen, Hajdú-Bihar, Hungary

Borbánya Praxis E.Ü. Kft.

Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, Hungary

PVN Kutató Kft.

Budapest, Hungary

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Policlinico Mater Domini Università di Catanzaro

Catanzaro, Italy

IRCCS Ospedale San Raffaele Milano

Milan, Italy

Azienda Ospealiero Universitaria Policlinico Umberto I

Roma, Italy

Centrum Medyczne Medyk Sp. z o.o.

Rzeszów, Podkarpackie Voivodeship, Poland

Osteo-Medic s.c. A. Racewicz, J. Supronik

Bialystok, Poland

Renew Clinic Sp. z o.o.

Bialystok, Poland

Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

Lodz, Poland

NBR Polska Tomasz Klodawski

Warsaw, Poland

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, Poland

Velocity Nova Sp. z o.o.

Zamość, Poland

King Abdulaziz Hospital-Al Ahsa-National Guard

Al Ahsa, Saudi Arabia

National Guard Hospital - Jeddah

Jeddah, Saudi Arabia

King Fahad Medical City

Riyadh, Saudi Arabia

King Khaled University Hospital,King Saud Univ. Med. City

Riyadh, Saudi Arabia

King Salman Bin Abdulaziz Hospital

Riyadh, Saudi Arabia

CHC Zvezdara, Clinical department for endocrinology

Belgrade, Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

Clinical Hospital Centre Zemun

Belgrade, Serbia

Policlinic for diabetes

Zaječar, Serbia