NCT05564117CompletedPhase 3
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 307 (actual)
- First submitted
- 29 Sept 2022
- Start date
- 11 Oct 2022
- Primary completion date
- 18 Apr 2024
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT05564117
- EudraCT number
- 2021-006534-40
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 307
- From 11 Oct 2022 to the primary completion date, 18 Apr 2024
- 23 sites in 4 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 kg (11 pound \[lbs\]) within 90 days before screening irrespective of medical records
Lab values
- HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
Who the study is looking for
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Body mass index (BMI) of
- Greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
- Greater than or equal to 30.0 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 (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wharton Med Clin Trials Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| G.A. Research Associates, Ltd. Coordinator of this site? Confirm its status | Moncton | Canada | Unknown status |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz Coordinator of this site? Confirm its status | Lingen | 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 |
| MZM Praxis Drs. Erlinger Coordinator of this site? Confirm its status | Stuttgart | Germany | Unknown status |
| Praxis für Prävention und Therapie, Drs Jacob Coordinator of this site? Confirm its status | Villingen-Schwenningen | Germany | Unknown status |
| Zentrum für klinische Studien Allgäu Oberschwaben Coordinator of this site? Confirm its status | Wangen | Germany | Unknown status |
| Gabinet Leczenia Otylosci i Chorob Dietozaleznych Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j. Coordinator of this site? Confirm its status | Legnica | Poland | Unknown status |
| ETG Lublin Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Centrum Zdrowia Metabolicznego Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| ETG Siedlce Coordinator of this site? Confirm its status | Siedlce | Poland | Unknown status |
| Etg Warszawa Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Washington Cntr Weight Mgmt Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Univsty Of AL At Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| FDRC Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
| UT Southwestern Med Cntr Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| East West Medical Research Institute_Honolulu Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Accellacare Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Selma Medical Associates Coordinator of this site? Confirm its status | Winchester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.