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

Last updated: January 28, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

Semaglutide

Placebo

Clinical Study ID

NCT05646706
NN9536-4999
U1111-1274-4259
2022-000790-94
  • Ages > 18
  • All Genders

Study Summary

This study will look at how much weight participants will lose 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. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female.

  • Age above or equal to 18 years at the time of signing informed consent.

  • Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2).

  • History of at least one self-reported unsuccessful dietary effort to lose bodyweight.

Exclusion

Exclusion Criteria:

  • HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) asmeasured by the central laboratory at screening.

  • History of type 1 or type 2 diabetes.

  • Treatment with glucose-lowering agent(s) within 90 days before screening.

  • A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds)within 90 days before screening irrespective of medical records.

  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2or medullary thyroid carcinoma.

Study Design

Total Participants: 1407
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
January 04, 2023
Estimated Completion Date:
November 26, 2024

Connect with a study center

  • Medical centre "Zdrave 1" OOD

    Kozloduy, 3320
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Kozloduy, 3320
    Bulgaria

    Site Not Available

  • Medical center Hippocrates-Lukovit

    Lukovit, 5770
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Lukovit, 5770
    Bulgaria

    Site Not Available

  • Individual Practice for medical care -Dr Elizabeta Dimitrova

    Petrich, 2850
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Petrich, 2850
    Bulgaria

    Site Not Available

  • "Medical center Smolyan clinical research" OOD

    Smolyan, 4700
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Smolyan, 4700
    Bulgaria

    Site Not Available

  • Acibadem City Clinic MHAT Tokuda Department of Endocrinology

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Diagnostic Consulting Center Ascendent

    Sofia, 1202
    Bulgaria

    Site Not Available

  • Medical centre "Medical arts medico-dental centre"

    Sofia, 1618
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Specialized gynaecology hospital for active treatment Dr Shterev

    Sofia, 1330
    Bulgaria

    Site Not Available

  • "Ambulatory for individual practice and specialized medical care Dr. Evelina Zlatanova" EOOD

    Varna, 9010
    Bulgaria

    Site Not Available

  • "Medical Center Medical Plus" Eood

    Varna, 9000
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Varna, 9000
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Surrey, British Columbia V3Z 2N6
    Canada

    Site Not Available

  • Ocean West Research Clinic

    Surrey, British Columbia V3Z 2N6
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Hamilton Med Res Group

    Hamilton, Ontario L8M 1K7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario L8L 5G4
    Canada

    Site Not Available

  • Wharton Med Clin Trials

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Milestone Research

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Benátky Na Jizerou, 29471
    Czechia

    Site Not Available

  • Ordinace praktického lékaře

    Benátky Na Jizerou, 29471
    Czechia

    Site Not Available

  • Edumed Broumov

    Broumov, 550 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Broumov, 550 01
    Czechia

    Site Not Available

  • Fledip s.r.o.

    Praha, 160 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha, 160 00
    Czechia

    Site Not Available

  • Fakultní nemocnice Královské Vinohrady_Praha 10

    Praha 10, 10034
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 10, 10034
    Czechia

    Site Not Available

  • Endocare

    Praha 4, 140 00
    Czechia

    Site Not Available

  • Institut klinické a experimentalni mediciny

    Praha 4, 14021
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 4, 149 00
    Czechia

    Site Not Available

  • Poliklinika Michnova - Obezitologie

    Praha 4, 149 00
    Czechia

    Site Not Available

  • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

    Berlin, 13597
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, 13597
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Elsterwerda, 04910
    Germany

    Site Not Available

  • Zentrum fuer klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04910
    Germany

    Site Not Available

  • InnoDiab Forschung GmbH

    Essen, 45136
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Essen, 45136
    Germany

    Site Not Available

  • Praxis Dr. med. M. Esser

    Essen, 45219
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Falkensee, 14612
    Germany

    Site Not Available

  • Zentrum für klinische Forschung, Dr. med. Lüdemann

    Falkensee, 14612
    Germany

    Site Not Available

  • MedicalCenter am Clemenshospital

    Münster, 48153
    Germany

    Site Not Available

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Münster, 48153
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Oldenburg I. Holst, 23758
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Oldenburg in Holstein, 23758
    Germany

    Site Not Available

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Praxis Dr. med. Wenzl-Bauer

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Wangen, 88239
    Germany

    Site Not Available

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239
    Germany

    Site Not Available

  • Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann

    Witten, 58455
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Witten, 58455
    Germany

    Site Not Available

  • University Hospital of Athens ATTIKON

    Athens, Attica 12462
    Greece

    Site Not Available

  • University Hospital of Athens ATTIKON

    Haidari-Athens, Attica GR-12462
    Greece

    Site Not Available

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

    Athens, 11527
    Greece

    Site Not Available

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, GR-17562
    Greece

    Site Not Available

  • Iatriko Athinon (Athens Medical Canter)

    Athens, GR-15125
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Athens, GR-15125
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Haidari-Athens, GR-12462
    Greece

    Site Not Available

  • General Hospital of Lamia

    Lamia, GR35100
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Lamia, GR35100
    Greece

    Site Not Available

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, GR-54642
    Greece

    Site Not Available

  • "Thermi" Private Hosital

    Thessaloniki, GR-57001
    Greece

    Site Not Available

  • AHEPA General University Hospital

    Thessaloniki, GR-54636
    Greece

    Site Not Available

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, GR-54635
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57001
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Baja, Bács-Kiskun 6500
    Hungary

    Site Not Available

  • Lausmed Kft.

    Baja, Bács-Kiskun Vármegye 6500
    Hungary

    Site Not Available

  • Belinus Bt.

    Debrecen, Hajdu-Bihar Varmegye 4025
    Hungary

    Site Not Available

  • Borbánya Praxis E.Ü. Kft.

    Nyíregyháza, Szabolcs-Szatmar Varmegye 4405
    Hungary

    Site Not Available

  • Bajcsy-Zsilinszky Kórház

    Budapest, 1106
    Hungary

    Site Not Available

  • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1089
    Hungary

    Site Not Available

  • MED-TIMA Kft.

    Budapest, 1132
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Budapest, 1106
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Debrecen, 4025
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Nyíregyháza, 4405
    Hungary

    Site Not Available

  • Fejér Megyei Szent György Oktatókórház

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Falck Norge AS

    Hamar, 2317
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamar, 2317
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Oslo, 0373
    Norway

    Site Not Available

  • Oslo universitetssykehus HF Aker

    Oslo, 0373
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Tønsberg, 3116
    Norway

    Site Not Available

  • Sykehuset i Vestfold HF, Tønsberg

    Tønsberg, 3116
    Norway

    Site Not Available

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, Lubelski 20-538
    Poland

    Site Not Available

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

    Lublin, Lubelskie 20-044
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lublin, Lubelskie 20-044
    Poland

    Site Not Available

  • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

    Krakow, Malopolskie 31-261
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Krakow, Malopolskie 31-261
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warsaw, Mazowieckie 00-465
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warszawa, Mazowieckie 00-710
    Poland

    Site Not Available

  • Kresmed Sp. z o. o.

    Bialystok, Podlaskie 15-481
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Bialystok, Podlaskie 15-481
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomorskie 81-338
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdynia, Pomorskie 81-338
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Katowice, 40-752
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne SUM w Katowicach

    Katowice, 40-752
    Poland

    Site Not Available

  • NBR Polska Tomasz Klodawski

    Warszawa, 00-710
    Poland

    Site Not Available

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warszawa, 02-507
    Poland

    Site Not Available

  • Unidade Local de Saúde de Matosinhos

    Senhora Da Hora, Matosinhos, Matosinhos 4464-513
    Portugal

    Site Not Available

  • Unidade Local de Saúde de Matosinhos

    Senhora da Hora, Matosinhos 4464-513
    Portugal

    Site Not Available

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisboa, 1250-230
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Lisboa, 1250-230
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Matosinhos, 4464-513
    Portugal

    Site Not Available

  • Unidade Local de Saúde de Matosinhos

    Matosinhos, 4464-513
    Portugal

    Site Not Available

  • Centro Hospitalar de São João

    Porto, 4200-319
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Porto, 4200-319
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Vila Nova de Gaia, 4400-346
    Portugal

    Site Not Available

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

    Bratislava, 842 31
    Slovakia

    Site Not Available

  • MUDr. Dagmar Prokesova, Endokrinologicka ambulancia

    Bratislava, 821 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Bratislava, 821 01
    Slovakia

    Site Not Available

  • Diabetologicka ambulancia IN-DIA s.r.o.

    Lucenec, 984 01
    Slovakia

    Site Not Available

  • IN-DIA s.r.o.

    Lucenec, 984 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Lucenec, 984 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Malacky, 901 01
    Slovakia

    Site Not Available

  • SIN AZUCAR s.r.o.

    Malacky, 901 01
    Slovakia

    Site Not Available

  • MED-CENTRUM, s.r.o.

    Martin, 036 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Martin, 036 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Presov, 080 01
    Slovakia

    Site Not Available

  • SVAJDLEROVA, s.r.o.

    Presov, 080 01
    Slovakia

    Site Not Available

  • Dom srdca, s.r.o.

    Zilina, 01001
    Slovakia

    Site Not Available

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

    Zilina, 010 01
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Zilina, 01001
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape 6001
    South Africa

    Site Not Available

  • Phoenix Pharma

    Port Elizabeth, Eastern Cape 6001
    South Africa

    Site Not Available

  • Medi-Clinic Bloemfontein

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Deepak Lakha

    Johannesburg, Gauteng 1820
    South Africa

    Site Not Available

  • Hemant Makan

    Johannesburg, Gauteng 1827
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng 1827
    South Africa

    Site Not Available

  • Soweto Clinical Trial Centre

    Johannesburg, Gauteng 1818
    South Africa

    Site Not Available

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng 2013
    South Africa

    Site Not Available

  • Dr N.K. Gounden Medical Centre

    Durban, KwaZulu Natal 4093
    South Africa

    Site Not Available

  • Maxwell Centre

    Durban, KwaZulu-Natal 4001
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal 4001
    South Africa

    Site Not Available

  • Dr T Padayachee

    Umkomaas, KwaZulu-Natal 4170
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Umkomaas, KwaZulu-Natal 4170
    South Africa

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Univ of Alabama Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Healthscan Clinical Trials,LLC.

    Montgomery, Alabama 36106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Montgomery, Alabama 36106
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Florida Inst For Clin Res LLC

    Orlando, Florida 32825
    United States

    Site Not Available

  • Florida Institute For Clinical Research LLC

    Orlando, Florida 32825
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orlando, Florida 32825
    United States

    Site Not Available

  • East West Med Res Inst

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Midwest Inst For Clin Res

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albany, New York 12203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Medical University Of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Amarillo Med Spec LLP

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Elligo Clin Res Centre

    Austin, Texas 78704
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78704
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Medical Center-CRU

    Dallas, Texas 75390
    United States

    Site Not Available

  • Velocity Clin Res, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • DCOL Ctr for Clin Res

    Longview, Texas 75605
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Longview, Texas 75605
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Sugar Lakes Family Practice PA

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • National Clin Res Inc.

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

  • Selma Medical Associates

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

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