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NCT05646706CompletedPhase 3

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

Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1407 (actual)
First submitted
2 Dec 2022
Start date
Jan 2023
Primary completion date
Oct 2024
Lead sponsor
Novo Nordisk A/S
Diseases
Obesity
NCT number
NCT05646706
EudraCT number
2022-000790-94

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1407
  • From Jan 2023 to the primary completion date, Oct 2024
  • 107 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • History of type 1 or type 2 diabetes.
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

Lab values

  • HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.
  • Treatment with glucose-lowering agent(s) within 90 days before screening.

Who the study is looking for

  • 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 body weight.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (107)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical centre Zdrave 1 OOD
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KozloduyBulgariaUnknown status
Medical center Hippocrates Lukovit EOOD
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LukovitBulgariaUnknown status
IPMC - Dr. Elizabeta Dimitrova
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PetrichBulgariaUnknown status
Medical center Smolyan clinical research OOD
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SmolyanBulgariaUnknown status
DCC Ascendent OOD
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SofiaBulgariaUnknown status
Medical Centre Medical Arts Medico-dental centre
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SofiaBulgariaUnknown status
Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology
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SofiaBulgariaUnknown status
SGHAT Dr. Shterev EOOD
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SofiaBulgariaUnknown status
Medical Center Medical Plus EOOD
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VarnaBulgariaUnknown status
AIPSMC Dr. Evelina Zlatanova EOOD
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VarnaBulgariaUnknown status
Nova Scotia Hlth Halifax
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HalifaxCanadaUnknown status
Nova Scotia Health Authority
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HalifaxCanadaUnknown status
Wharton Medical Clinic Clinical Trials (Hamilton)
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HamiltonCanadaUnknown status
Premier Clinical Trial Research Network (PCTRN)
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HamiltonCanadaUnknown status
Hamilton Med Res Group
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HamiltonCanadaUnknown status
Wharton Med Clin Trials
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HamiltonCanadaUnknown status
Milestone Research
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LondonCanadaUnknown status
Ocean West Research Clinic
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SurreyCanadaUnknown status
Ordinace praktického lékaře
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Benátky Na JizerouCzechiaUnknown status
EDUMED - Broumov
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BroumovCzechiaUnknown status
Fledip s.r.o.
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PragueCzechiaUnknown status
Fakultní nemocnice Královské Vinohrady_Praha 10
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PragueCzechiaUnknown status
Endocare
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PragueCzechiaUnknown status
Institut klinicke a experimentalni mediciny
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PragueCzechiaUnknown status
Poliklinika Michnova - Obezitologie
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PragueCzechiaUnknown status
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
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BerlinGermanyUnknown status
Zentrum fuer klinische Studien Suedbrandenburg GmbH
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ElsterwerdaGermanyUnknown status
Praxis Dr. med. M. Esser
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EssenGermanyUnknown status
InnoDiab Forschung Gmbh
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EssenGermanyUnknown status
Zentrum für klinische Forschung, Dr. med. Lüdemann
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FalkenseeGermanyUnknown status
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
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MünsterGermanyUnknown status
RED-Institut für medizinische Forschung und Fortbildung GmbH
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Oldenburg in HolsteinGermanyUnknown status
Praxis Dr. med. Wenzl-Bauer
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Rehlingen-SiersburgGermanyUnknown status
Zentrum für klinische Studien Allgäu Oberschwaben
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WangenGermanyUnknown status
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
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WittenGermanyUnknown status
Iatriko Athinon (Athens Medical Canter)
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AthensGreeceUnknown status
University Hospital of Athens ATTIKON
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AthensGreeceUnknown status
Iatriko Athinon 'Palaiou Falirou'
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AthensGreeceUnknown status
Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
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AthensGreeceUnknown status
General Hospital of Lamia
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LamiaGreeceUnknown status
"Ippokrateio" G.H. of Thessaloniki
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ThessalonikiGreeceUnknown status
General Hospital of Thessaloniki G. Gennimatas
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ThessalonikiGreeceUnknown status
"Thermi" Private Hosital
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ThessalonikiGreeceUnknown status
AHEPA General University Hospital
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ThessalonikiGreeceUnknown status
Lausmed Kft
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BajaHungaryUnknown status
Bajcsy-Zsilinszky Kórház
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BudapestHungaryUnknown status
Med-Tima Kft
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BudapestHungaryUnknown status
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
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BudapestHungaryUnknown status
Belinus Bt.
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DebrecenHungaryUnknown status
Borbánya Praxis E.Ü. Kft.
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NyíregyházaHungaryUnknown status
Fejér Megyei Szent György Oktatókórház
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SzékesfehérvárHungaryUnknown status
Falck Norge AS
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HamarNorwayUnknown status
Oslo universitetssykehus HF Aker
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OsloNorwayUnknown status
Sykehuset i Vestfold HF, Tønsberg
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TønsbergNorwayUnknown status
Kresmed Sp. z o. o.
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BialystokPolandUnknown status
Centrum Medyczne Pratia Gdynia
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GdyniaPolandUnknown status
Uniwersyteckie Centrum Kliniczne, SUM w Katowicach
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KatowicePolandUnknown status
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
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KrakowPolandUnknown status
NZOZ "CenterMed Lublin" Sp. z o.o.
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LublinPolandUnknown status
NZOZ Przychodnia Specjalistyczna Medica
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LublinPolandUnknown status
Nbr Polska Tomasz Klodawski
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WarsawPolandUnknown status
Panstwowy Instytut Medyczny Mswia
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WarsawPolandUnknown status
Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
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LisbonPortugalUnknown status
APDP - Associação Protectora dos Diabéticos de Portugal
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LisbonPortugalUnknown status
Hospital da Luz Lisboa, S.A.
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LisbonPortugalUnknown status
ULS De São João, E.P.E. - Hospital de São João
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PortoPortugalUnknown status
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
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Senhora Da Hora, MatosinhosPortugalUnknown status
Hospital da Luz Arrabida, S.A.
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Vila Nova de GaiaPortugalUnknown status
MUDr. Dagmar Prokesova, Endokrinologicka ambulancia
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BratislavaSlovakiaUnknown status
MEDIMAD, s.r.o., Endokrinologicka ambulancia
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BratislavaSlovakiaUnknown status
IN-DIA s.r.o.
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LučenecSlovakiaUnknown status
SIN AZUCAR s.r.o.
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MalackySlovakiaUnknown status
MED-CENTRUM, s.r.o.
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MartinSlovakiaUnknown status
SVAJDLEROVA, s.r.o.
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PrešovSlovakiaUnknown status
MEDIVASA, s.r.o., Angiologicka ambulancia
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ŽilinaSlovakiaUnknown status
Dom srdca, s.r.o.
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ŽilinaSlovakiaUnknown status
AMC Community Endocrinology
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AlbanyUnited StatesUnknown status
Amarillo Med Spec LLP
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AmarilloUnited StatesUnknown status
Elligo Clin Res Centre
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AustinUnited StatesUnknown status
Univ of Alabama Birmingham
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BirminghamUnited StatesUnknown status
University of North Carolina
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
UT Southwestern Medical Center-CRU
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DallasUnited StatesUnknown status
Velocity Clin Res, Dallas
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DallasUnited StatesUnknown status
PharmQuest Life Sciences LLC
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GreensboroUnited StatesUnknown status
East West Med Res Inst
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HonoluluUnited StatesUnknown status
Midwest Inst For Clin Res
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IndianapolisUnited StatesUnknown status
Jacksonville Ctr for Clin Res
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JacksonvilleUnited StatesUnknown status
DCOL Ctr for Clin Res
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LongviewUnited StatesUnknown status
Healthscan Clinical Trials,LLC.
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MontgomeryUnited StatesUnknown status
Chambliss Clinical Trials, LLC
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MontgomeryUnited StatesUnknown status
Florida Inst For Clin Res LLC
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OrlandoUnited StatesUnknown status
Florida Institute For Clinical Research, LLC
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OrlandoUnited StatesUnknown status
National Clin Res Inc.
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RichmondUnited StatesUnknown status
Sugar Lakes Family Practice, PA
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Sugar LandUnited StatesUnknown status
Diablo Clinical Research, Inc.
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Walnut CreekUnited StatesUnknown status
Selma Medical Associates
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WinchesterUnited StatesUnknown status
Medi-Clinic Bloemfontein
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BloemfonteinSouth AfricaUnknown status
Lenmed Shifa Private Hospital
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DurbanSouth AfricaUnknown status
Precise Clinical Solutions (Pty) Ltd
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DurbanSouth AfricaUnknown status
Dr N.K. Gounden Medical Centre
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DurbanSouth AfricaUnknown status
Dr T Padayachee
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eMkhomaziSouth AfricaUnknown status
Hemant Makan
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JohannesburgSouth AfricaUnknown status
Deepak Lakha
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JohannesburgSouth AfricaUnknown status
Soweto Clinical Trial Centre
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JohannesburgSouth AfricaUnknown status
-
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JohannesburgSouth AfricaUnknown status
Phoenix Pharma
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Port ElizabethSouth AfricaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.