Clinical trial
Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight
Recruiting now · Phase 3 · 8 countries · Registry ID NCT07770841
Recruiting nowPhase 3Interventional
What this study is about
The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity
Full registry criteria
Inclusion Criteria: * 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. * Female or male (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Body mass index (BMI) of 1. ≥ 27.0 kilogram per square meter (kg/m\^2) with the presence of at least one weight-related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease. OR 2. ≥ 30.0 kg/m\^2. * History of at least one self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: * A self-reported change in body weight greater than (\>) 5% within 90 days before screening irrespective of medical records. * HbA1c ≥ 6.5% (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening. * Consistent use of glucagon like peptide-1 (GLP-1) receptor agonists, including medication with glucagon like peptide-1 receptor agonist (GLP-1 RA) activity like dual GLP-1/gastric inhibitory peptide RAs, or amylin analogues before screening. Consistent use is defined as treatment.
Treatments and study arms
Semaglutide
Drug
Participants will receive semaglutide orally.
Placebo
Drug
Participants will receive placebo orally.
Primary outcomes
Relative change in body weightFrom baseline (week 0) to week 60
Measured as percentage change in body weight.
Study locations
62 locations were listed when this page was built. The first 40 are shown.
Anima Research Center🇧🇪 Alken, Belgium
Imelda🇧🇪 Bonheiden, Belgium
UZ Brussel - Universitair Ziekenhuis Brussel🇧🇪 Brussels, Belgium
Universitair Ziekenhuis Gent🇧🇪 Ghent, Belgium
KORMONT🇧🇪 Kluisbergen, Belgium
AIPSMC - DiMed EOOD🌐 Haskovo, Bulgaria
Medical Center Zdrave Lom EOOD🌐 Lom, Bulgaria
IPMC - Dr. Elizabeta Dimitrova🌐 Petrich, Bulgaria
MHAT Hadzhi Dimitar OOD🌐 Sliven, Bulgaria
DCC Neoklinik EAD🌐 Sofia, Bulgaria
DCC 1 Velingrad EOOD🌐 Velingrad, Bulgaria
Aarhus Universitetshospital, Steno Diabetes Center Aarhus🇩🇰 Aarhus N, Denmark
Gentofte Hospital - Center for Klinisk Metabolisk Forskning🇩🇰 Hellerup, Denmark
Regionshospitalet Gødstrup, Hjertesygdomme🇩🇰 Herning, Denmark
Hôpital Privé Saint Martin_Service de chirurgie digestive🇫🇷 Caen, France
LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie🇫🇷 Le Coudray, France
Hôpital Privé La Louvière_Service de chirurgie🇫🇷 Lille, France
CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques🇫🇷 Vénissieux, France
City Hospital Kliniki Monoprosopi I.K.E.🇬🇷 Kalamata, Greece
Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit🇬🇷 Marousi, Greece
Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department🇬🇷 Peristeri, Greece
NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes🇬🇷 Thessaloniki, Greece
Thermi Clinic S.A. - Diabetes and Internal Medicine Department🇬🇷 Thessaloniki, Greece
Progress Clinical Research Amsterdam🇳🇱 Amsterdam, Netherlands
Praktijk Dokters van Nederhoven🇳🇱 Zwijndrecht, Netherlands
Progress Clinical Research Zwolle🇳🇱 Zwolle, Netherlands
Kresmed Sp. z o. o.🇵🇱 Bialystok, Poland
Athleticomed Sp. z o.o.🇵🇱 Bydgoszcz, Poland
Gierach-Med🇵🇱 Bygdoszcz, Poland
Santa Sp. z o.o.🇵🇱 Lodz, Poland
Centrum Zdrowia Metabolicznego Paweł Bogdański🇵🇱 Poznan, Poland
Velocity Nova Sp. z o.o.🇵🇱 Staszów, Poland
Care Access Polska Sp. Z o.o.🇵🇱 Warsaw, Poland
FutureMeds Sp. z o.o.🇵🇱 Warsaw, Poland
NBR Polska Tomasz Klodawski🇵🇱 Warsaw, Poland
Centro Periferico De Especialidades Bola Azul🇪🇸 Almería, Spain
Hospital Vithas Sevilla🇪🇸 Castilleja de la Cuesta, Spain
Hospital Naval Ferrol🇪🇸 Ferrol, Spain
HU de Fuenlabrada_Endocrinología🇪🇸 Fuenlabrada, Madrid, Spain
Clínica Palacios Madrid🇪🇸 Madrid, Spain