A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

PHASE3CompletedINTERVENTIONAL
Enrollment

512

Participants

Timeline

Start Date

January 4, 2023

Primary Completion Date

October 28, 2024

Study Completion Date

December 13, 2024

Conditions
ObesityDiabetes Mellitus, Type 2
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (68)

1089

ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest

1106

Bajcsy-Zsilinszky Kórház, Budapest

1132

MED-TIMA Kft., Budapest

1233

DCC VII - Sofia EOOD, Endocrinology, Sofia

1820

Deepak Lakha, Johannesburg

1827

Hemant Makan, Johannesburg

2013

Wits Bara Clinical Trial Site, Johannesburg

2700

"MHAT-Blagoevgrad, Department of Internal Diseases", Blagoevgrad

4001

Maxwell Centre, Durban

4004

'MHAT Sveta Karidad' EAD, Plovdiv

4025

Belinus Bt., Debrecen

4093

Dr N.K. Gounden Medical Centre, Durban

4170

Dr T Padayachee, eMkhomazi

4400

UMHAT Pulmed, Department of endocrinology, Pazardzhik

4405

Borbánya Praxis E.Ü. Kft., Nyíregyháza

4901

Lenmed Shifa Private Hospital, Durban

6001

Phoenix Pharma, Port Elizabeth

6003

"UMHAT- Prof. dr. Stoyan Kirkovich", Stara Zagora

6500

Lausmed Kft., Baja

8000

IPSOMC - Dr. Georgi Marinov, Burgas

Fejér Megyei Szent György Oktatókórház, Székesfehérvár

8600

"MHAT Sveti Panteleimon - Yambol AD", Yambol

8800

'MHAT Hadzhi Dimitar' OOD, Sliven

9300

"Medical Center Viva Feniks Ood", Dobrich

9301

Medi-Clinic Bloemfontein, Bloemfontein

23294

National Clin Res Inc., Richmond

27408

PharmQuest Life Sciences LLC, Greensboro

27514

University of North Carolina, Chapel Hill

30094

Hope Clin Res & Wellness, Conyers

32216

Jacksonville Ctr for Clin Res, Jacksonville

32720

ARS- Deland CRU, DeLand

32765

Oviedo Medical Research, LLC, Oviedo

32825

Florida Inst For Clin Res LLC, Orlando

35222

Univ of Alabama Birmingham, Birmingham

75230

Velocity Clin Res, Dallas, Dallas

75390

UT Southwestern Medical Center - Lingvay, Dallas

75605

DCOL Ctr for Clin Res, Longview

77079

PlanIt Research, PLLC, Houston

77479

Sugar Lakes Family Practice PA, Sugar Land

78704

Elligo Clin Res Centre, Austin

79106

Amarillo Med Spec LLP, Amarillo

80401

New West Physicians PC, Golden

90057

Velocity Clinical Research Westlake, Los Angeles

94520

John Muir Physicians Network, Concord

94598

Diablo Clinical Research, Inc., Walnut Creek

22601-3834

Selma Medical Associates, Winchester

V3Z 2N6

Ocean West Research Clinic, Surrey

E1G 1A7

G.A. Research Associates Ltd., Moncton

B3H 1V7

Nova Scotia Hlth Halifax, Halifax

L8L 5G4

Premier Clinical Trial Research Network (PCTRN), Hamilton

L8L 5G8

Wharton Med Clin Trials, Hamilton

N5W 6A2

Milestone Research, London

31-261

Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET, Krakow

20-538

NZOZ Przychodnia Specjalistyczna Medica, Lublin

20-044

"NZOZ CenterMed Lublin Sp. z o.o.", Lublin

15-481

Kresmed Sp. z o. o., Bialystok

40-752

Uniwersyteckie Centrum Kliniczne SUM w Katowicach, Katowice

00-710

NBR Polska Tomasz Klodawski, Warsaw

02-507

PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warsaw

4464-513

Unidade Local De Saude De Matosinhos E.P.E., Senhora Da Hora, Matosinhos

1250-230

APDP - Associação Protectora dos Diabéticos de Portugal, Lisbon

4200-319

Unidade Local de Saude de Sao Joao E.P.E, Porto

08501

DIADA s.r.o., Bardejov

DIADA, s.r.o., Bardejov

014 01

Diab - Int, s.r.o., Bytča

04013

ENDOMED, s.r.o., Košice

01701

MED-DIA CENTRUM s.r.o., Považská Bystrica

080 01

DIABETOL, s.r.o., Prešov

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY