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
Sites (107)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical centre Zdrave 1 OOD Coordinator of this site? Confirm its status | Kozloduy | Bulgaria | Unknown status |
| Medical center Hippocrates Lukovit EOOD Coordinator of this site? Confirm its status | Lukovit | Bulgaria | Unknown status |
| IPMC - Dr. Elizabeta Dimitrova Coordinator of this site? Confirm its status | Petrich | Bulgaria | Unknown status |
| Medical center Smolyan clinical research OOD Coordinator of this site? Confirm its status | Smolyan | Bulgaria | Unknown status |
| DCC Ascendent OOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Medical Centre Medical Arts Medico-dental centre Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| SGHAT Dr. Shterev EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Medical Center Medical Plus EOOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Unknown status |
| AIPSMC Dr. Evelina Zlatanova EOOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Unknown status |
| Nova Scotia Hlth Halifax Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Wharton Medical Clinic Clinical Trials (Hamilton) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Premier Clinical Trial Research Network (PCTRN) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Hamilton Med Res Group Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Wharton Med Clin Trials Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Milestone Research Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Ocean West Research Clinic Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Ordinace praktického lékaře Coordinator of this site? Confirm its status | Benátky Na Jizerou | Czechia | Unknown status |
| EDUMED - Broumov Coordinator of this site? Confirm its status | Broumov | Czechia | Unknown status |
| Fledip s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Fakultní nemocnice Královské Vinohrady_Praha 10 Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Endocare Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Institut klinicke a experimentalni mediciny Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Poliklinika Michnova - Obezitologie Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Zentrum fuer klinische Studien Suedbrandenburg GmbH Coordinator of this site? Confirm its status | Elsterwerda | Germany | Unknown status |
| Praxis Dr. med. M. Esser Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Zentrum für klinische Forschung, Dr. med. Lüdemann Coordinator of this site? Confirm its status | Falkensee | Germany | Unknown status |
| MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| RED-Institut für medizinische Forschung und Fortbildung GmbH Coordinator of this site? Confirm its status | Oldenburg in Holstein | Germany | Unknown status |
| Praxis Dr. med. Wenzl-Bauer Coordinator of this site? Confirm its status | Rehlingen-Siersburg | Germany | Unknown status |
| Zentrum für klinische Studien Allgäu Oberschwaben Coordinator of this site? Confirm its status | Wangen | Germany | Unknown status |
| Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann Coordinator of this site? Confirm its status | Witten | Germany | Unknown status |
| Iatriko Athinon (Athens Medical Canter) Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University Hospital of Athens ATTIKON Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Iatriko Athinon 'Palaiou Falirou' Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| General Hospital of Lamia Coordinator of this site? Confirm its status | Lamia | Greece | Unknown status |
| "Ippokrateio" G.H. of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| General Hospital of Thessaloniki G. Gennimatas Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| "Thermi" Private Hosital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| AHEPA General University Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Lausmed Kft Coordinator of this site? Confirm its status | Baja | Hungary | Unknown status |
| Bajcsy-Zsilinszky Kórház Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Med-Tima Kft Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Belinus Bt. Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Borbánya Praxis E.Ü. Kft. Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Unknown status |
| Fejér Megyei Szent György Oktatókórház Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Unknown status |
| Falck Norge AS Coordinator of this site? Confirm its status | Hamar | Norway | Unknown status |
| Oslo universitetssykehus HF Aker Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Sykehuset i Vestfold HF, Tønsberg Coordinator of this site? Confirm its status | Tønsberg | Norway | Unknown status |
| Kresmed Sp. z o. o. Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Centrum Medyczne Pratia Gdynia Coordinator of this site? Confirm its status | Gdynia | Poland | Unknown status |
| Uniwersyteckie Centrum Kliniczne, SUM w Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| NZOZ "CenterMed Lublin" Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| NZOZ Przychodnia Specjalistyczna Medica Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Nbr Polska Tomasz Klodawski Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Panstwowy Instytut Medyczny Mswia Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| APDP - Associação Protectora dos Diabéticos de Portugal Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Hospital da Luz Lisboa, S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| ULS De São João, E.P.E. - Hospital de São João Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| ULS De Matosinhos E.P.E.- Hospital Pedro Hispano Coordinator of this site? Confirm its status | Senhora Da Hora, Matosinhos | Portugal | Unknown status |
| Hospital da Luz Arrabida, S.A. Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Unknown status |
| MUDr. Dagmar Prokesova, Endokrinologicka ambulancia Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| MEDIMAD, s.r.o., Endokrinologicka ambulancia Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| IN-DIA s.r.o. Coordinator of this site? Confirm its status | Lučenec | Slovakia | Unknown status |
| SIN AZUCAR s.r.o. Coordinator of this site? Confirm its status | Malacky | Slovakia | Unknown status |
| MED-CENTRUM, s.r.o. Coordinator of this site? Confirm its status | Martin | Slovakia | Unknown status |
| SVAJDLEROVA, s.r.o. Coordinator of this site? Confirm its status | Prešov | Slovakia | Unknown status |
| MEDIVASA, s.r.o., Angiologicka ambulancia Coordinator of this site? Confirm its status | Žilina | Slovakia | Unknown status |
| Dom srdca, s.r.o. Coordinator of this site? Confirm its status | Žilina | Slovakia | Unknown status |
| AMC Community Endocrinology Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Amarillo Med Spec LLP Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Elligo Clin Res Centre Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Univ of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| UT Southwestern Medical Center-CRU Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Velocity Clin Res, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| PharmQuest Life Sciences LLC Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| East West Med Res Inst Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Midwest Inst For Clin Res Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Jacksonville Ctr for Clin Res Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| DCOL Ctr for Clin Res Coordinator of this site? Confirm its status | Longview | United States | Unknown status |
| Healthscan Clinical Trials,LLC. Coordinator of this site? Confirm its status | Montgomery | United States | Unknown status |
| Chambliss Clinical Trials, LLC Coordinator of this site? Confirm its status | Montgomery | United States | Unknown status |
| Florida Inst For Clin Res LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Florida Institute For Clinical Research, LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| National Clin Res Inc. Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Sugar Lakes Family Practice, PA Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Diablo Clinical Research, Inc. Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Selma Medical Associates Coordinator of this site? Confirm its status | Winchester | United States | Unknown status |
| Medi-Clinic Bloemfontein Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| Lenmed Shifa Private Hospital Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Precise Clinical Solutions (Pty) Ltd Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Dr N.K. Gounden Medical Centre Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Dr T Padayachee Coordinator of this site? Confirm its status | eMkhomazi | South Africa | Unknown status |
| Hemant Makan Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Deepak Lakha Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Soweto Clinical Trial Centre Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Phoenix Pharma Coordinator of this site? Confirm its status | Port Elizabeth | South Africa | Unknown status |
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