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A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
Sponsor: Novo Nordisk A/S
Summary
This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years
Official title: Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
512
Start Date
2023-01-04
Completion Date
2024-12-13
Last Updated
2026-04-27
Healthy Volunteers
No
Conditions
Interventions
Semaglutide
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Semaglutide
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Placebo
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Locations (76)
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Chambliss Clinical Trials, LLC
Montgomery, Alabama, United States
John Muir Physicians Network
Concord, California, United States
Velocity Clinical Research Westlake
Los Angeles, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
New West Physicians PC
Golden, Colorado, United States
ARS- Deland CRU
DeLand, Florida, United States
Jacksonville Ctr for Clin Res
Jacksonville, Florida, United States
Florida Inst For Clin Res LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
AMC Community Endocrinology
Albany, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Amarillo Med Spec LLP
Amarillo, Texas, United States
Elligo Clin Res Centre
Austin, Texas, United States
Velocity Clin Res, Dallas
Dallas, Texas, United States
UT Southwestern Medical Center - Lingvay
Dallas, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
DCOL Ctr for Clin Res
Longview, Texas, United States
Sugar Lakes Family Practice PA
Sugar Land, Texas, United States
National Clin Res Inc.
Richmond, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
MHAT - Blagoevgrad AD, Department of Internal Diseases
Blagoevgrad, Bulgaria
IPSOMC - Dr. Georgi Marinov
Burgas, Bulgaria
Medical Center Viva Feniks OOD
Dobrich, Bulgaria
UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases
Pazardzhik, Bulgaria
MHAT Sveta Karidad EAD
Plovdiv, Bulgaria
MHAT Hadzhi Dimitar OOD
Sliven, Bulgaria
DCC VII - Sofia EOOD, Endocrinology
Sofia, Bulgaria
UMHAT Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, Bulgaria
MHAT Sveti Panteleimon - Yambol AD
Yambol, Bulgaria
Ocean West Research Clinic
Surrey, British Columbia, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario, Canada
Milestone Research
London, Ontario, Canada
Lausmed Kft.
Baja, Bács-Kiskun county, Hungary
Belinus Bt.
Debrecen, Hajdú-Bihar, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, Hungary
Bajcsy-Zsilinszky Kórház
Budapest, Hungary
MED-TIMA Kft.
Budapest, Hungary
Fejér Megyei Szent György Oktatókórház
Székesfehérvár, Hungary
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, Poland
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, Poland
NZOZ "CenterMed Lublin" Sp. z o.o.
Lublin, Lublin Voivodeship, Poland
Kresmed Sp. z o. o.
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
Katowice, Poland
NBR Polska Tomasz Klodawski
Warsaw, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, Poland
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, Portugal
Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, Portugal
Hospital da Luz Lisboa, S.A.
Lisbon, Portugal
ULS De São João, E.P.E. - Hospital de São João
Porto, Portugal
Hospital da Luz Arrabida, S.A.
Vila Nova de Gaia, Portugal
DIADA s.r.o.
Bardejov, Slovakia
DIADA, s.r.o.
Bardejov, Slovakia
Diab - Int, s.r.o.
Bytča, Slovakia
ENDOMED, s.r.o.
Košice, Slovakia
MED-DIA CENTRUM s.r.o.
Považská Bystrica, Slovakia
DIABETOL, s.r.o.
Prešov, Slovakia
Phoenix Pharma
Port Elizabeth, Eastern Cape, South Africa
Medi-Clinic Bloemfontein
Bloemfontein, Free State, South Africa
Soweto Clinical Trial Centre
Johannesburg, Gauteng, South Africa
Deepak Lakha
Johannesburg, Gauteng, South Africa
Hemant Makan
Johannesburg, Gauteng, South Africa
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, South Africa
Maxwell Centre
Durban, KwaZulu-Natal, South Africa
Precise Clinical Solutions (Pty) Ltd
Durban, KwaZulu-Natal, South Africa
Dr N.K. Gounden Medical Centre
Durban, KwaZulu-Natal, South Africa
Lenmed Shifa Private Hospital
Durban, KwaZulu-Natal, South Africa
Dr T Padayachee
eMkhomazi, KwaZulu-Natal, South Africa