A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,407

Participants

Timeline

Start Date

January 4, 2023

Primary Completion Date

October 30, 2024

Study Completion Date

November 26, 2024

Conditions
Obesity
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 was 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 was 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 (101)

1089

ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest

1106

Bajcsy-Zsilinszky Kórház, Budapest

1132

MED-TIMA Kft., Budapest

1202

DCC Ascendent OOD, Sofia

1330

SGHAT Dr. Shterev EOOD, Sofia

1407

Acibadem City Clinic MHAT Tokuda Department of Endocrinology, Sofia

1618

"Medical centre Medical arts medico-dental centre", Sofia

1818

Soweto Clinical Trial Centre, Johannesburg

1820

Deepak Lakha, Johannesburg

1827

Hemant Makan, Johannesburg

2013

Wits Bara Clinical Trial Site, Johannesburg

2317

Falck Norge AS, Hamar

2850

IPMC - Dr. Elizabeta Dimitrova, Petrich

3116

Sykehuset i Vestfold HF, Tønsberg, Tønsberg

3320

"Medical centre Zdrave 1 OOD", Kozloduy

4025

Belinus Bt., Debrecen

4093

Dr N.K. Gounden Medical Centre, Durban

4170

Dr T Padayachee, eMkhomazi

4405

Borbánya Praxis E.Ü. Kft., Nyíregyháza

4700

"Medical center Smolyan clinical research OOD", Smolyan

4901

Lenmed Shifa Private Hospital, Durban

5770

Medical center Hippocrates-Lukovit, Lukovit

6001

Phoenix Pharma, Port Elizabeth

6500

Lausmed Kft., Baja

8000

Fejér Megyei Szent György Oktatókórház, Székesfehérvár

9000

"Medical Center Medical Plus Eood", Varna

9010

AIPSMC Dr. Evelina Zlatanova EOOD, Varna

9301

Medi-Clinic Bloemfontein, Bloemfontein

10034

Fakultní nemocnice Královské Vinohrady_Praha 10, Prague

11527

Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter, Athens

12462

University Hospital of Athens ATTIKON, Athens

13597

Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR, Berlin

14021

Institut klinické a experimentalni mediciny, Prague

14612

Zentrum für klinische Forschung, Dr. med. Lüdemann, Falkensee

15125

Iatriko Athinon (Athens Medical Canter), Athens

17562

Iatriko Athinon 'Palaiou Falirou', Athens

23294

National Clin Res Inc., Richmond

23758

RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein

27408

PharmQuest Life Sciences LLC, Greensboro

27514

University of North Carolina, Chapel Hill

29425

Medical University Of South Carolina, Charleston

29471

Ordinace praktického lékaře, Benátky Na Jizerou

32216

Jacksonville Ctr For Clin Res, Jacksonville

32825

Florida Inst For Clin Res LLC, Orlando

Florida Institute For Clinical Research LLC, Orlando

35100

General Hospital of Lamia, Lamia

35294

Univ of Alabama Birmingham, Birmingham

36106

Chambliss Clinical Trials, LLC, Montgomery

Healthscan Clinical Trials,LLC., Montgomery

45136

InnoDiab Forschung GmbH, Essen

45219

Praxis Dr. med. M. Esser, Essen

46260

Midwest Inst For Clin Res, Indianapolis

48153

MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin, Münster

54635

General Hospital of Thessaloniki 'G. Gennimatas, Thessaloniki

54636

AHEPA General University Hospital, Thessaloniki

54642

"Ippokrateio G.H. of Thessaloniki", Thessaloniki

57001

"Thermi Private Hosital", Thessaloniki

58455

Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann, Witten

66780

Praxis Dr. med. Wenzl-Bauer, Rehlingen-Siersburg

75230

Velocity Clin Res, Dallas, Dallas

75390

UT Southwestern Medical Center-CRU, Dallas

75605

DCOL Ctr for Clin Res, Longview

77479

Sugar Lakes Family Practice PA, Sugar Land

78704

Elligo Clin Res Centre, Austin

79106

Amarillo Med Spec LLP, Amarillo

88239

Zentrum für klinische Studien Allgäu Oberschwaben, Wangen

94598

Diablo Clinical Research, Inc., Walnut Creek

96814

East West Med Res Inst, Honolulu

22601-3834

Selma Medical Associates, Winchester

V3Z 2N6

Ocean West Research Clinic, Surrey

B3H 1V7

Nova Scotia Health Authority, Halifax

Nova Scotia Hlth Halifax, Halifax

L8L 5G4

Premier Clinical Trial Research Network (PCTRN), Hamilton

L8L 5G8

Wharton Med Clin Trials, Hamilton

L8M 1K7

Hamilton Med Res Group, Hamilton

N5W 6A2

Milestone Research, London

550 01

Edumed Broumov, Broumov

140 00

Endocare, Prague

149 00

Poliklinika Michnova - Obezitologie, Prague

160 00

Fledip s.r.o., Prague

04910

Zentrum fuer klinische Studien Suedbrandenburg GmbH, Elsterwerda

0373

Oslo universitetssykehus HF Aker, Oslo

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

81-338

Centrum Medyczne Pratia Gdynia, Gdynia

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

821 01

MUDr. Dagmar Prokesova, Endokrinologicka ambulancia, Bratislava

842 31

MEDIMAD, s.r.o., Endokrinologicka ambulancia, Bratislava

984 01

IN-DIA s.r.o., Lučenec

901 01

SIN AZUCAR s.r.o., Malacky

036 01

MED-CENTRUM, s.r.o., Martin

080 01

SVAJDLEROVA, s.r.o., Prešov

010 01

MEDIVASA, s.r.o., Angiologicka ambulancia, Žilina

01001

Dom srdca, s.r.o., Žilina

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT05646706 - A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP) | Biotech Hunter | Biotech Hunter