NCT05486065CompletedPhase 2
A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 245 (actual)
- First submitted
- 31 Jul 2022
- Start date
- 8 Aug 2022
- Primary completion date
- 12 Oct 2023
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT05486065
- EudraCT number
- 2022-000882-41
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 245
- From 8 Aug 2022 to the primary completion date, 12 Oct 2023
- 130 sites in 5 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
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Lab values
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (\<) 30 milliliters per minute (mL/min)/1.73 meter square (m\^2) at screening.
Who the study is looking for
- Male or female.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
- Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) \[53 - 91 millimoles per mole (mmol/mol)\] (both inclusive).
- Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2).
- Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (130)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter 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 Psychicou Private Clinic Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Alexandra General Hospital, Therapeutic Clinic Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Iatriko Athinon (Athens Medical Canter) 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 |
| Univ Gen Hospital Larisa Coordinator of this site? Confirm its status | Larissa | Greece | Unknown status |
| EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes 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 |
| General Hospital of Thessaloniki "G. Papanikolaou" 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 |
| Ippokrateio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| MH Egészségügyi Központ 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 |
| Szent Margit Rendelőintézet Nonprofit Kft Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Bajcsy-Zsilinszky Kórház Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Komaromi Selye Janos Korhaz Coordinator of this site? Confirm its status | Komárom | Hungary | Unknown status |
| Kanizsai Dorottya Korhaz Coordinator of this site? Confirm its status | Nagykanizsa | Hungary | Unknown status |
| Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Szombathely | Hungary | Unknown status |
| NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| NZOZ Vita-Diabetica Malgorzata Buraczyk Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
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