Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight
Recruiting · NCT07770841 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSemaglutide
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
- ≥ 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.
- ≥ 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.
Where it is running
60 locations listed across 12 US states.
- Uni of Alabama at Birmingham - Birmingham, Alabama, United States
- Headlands Research California, LLC - Escondido, California, United States
- National Research Institute - Huntington Park - Huntington Park, California, United States
- Los Angeles Institute for Metabolic Research - Los Angeles, California, United States
- ERG Holding Company, LLC / Evolution Research Group, LLC - Delray Beach, Florida, United States
- ERG Holding Company, LLC / Evolution Research Group, LLC - Fort Myers, Florida, United States
- Jedidiah Clinical Research - Tampa, Florida, United States
- East West Med Res Inst - Honolulu, Hawaii, United States
- L-MARC Research Center - Louisville, Kentucky, United States
- StudyMetrix Research LLC - City of Saint Peters, Missouri, United States
- Jubilee Clinical Research, Inc. - Las Vegas, Nevada, United States
- Corvallis Clinic PC Clinical Research Department - Corvallis, Oregon, United States
- UPA Ctr Weight and Eating Dis - Philadelphia, Pennsylvania, United States
- Spartanburg Medical Research - Spartanburg, South Carolina, United States
- Cedar Health Research - Dallas, Texas, United States
- Selma Medical Associates - Winchester, Virginia, United States
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus - Aarhus N, Denmark
- Anima Research Center - Alken, Belgium
- CPE Bola Azul_Endocrinología y Nutrición - Almería, Spain
- Progress Clinical Research Amsterdam - Amsterdam, Netherlands
- Kresmed Sp. z o. o. - Bialystok, Poland
- Imelda - Bonheiden, Belgium
- UZ Brussel - Universitair Ziekenhuis Brussel - Brussels, Belgium
- Athleticomed Sp. z o.o. - Bydgoszcz, Poland
- Gierach-Med - Bygdoszcz, Poland
- Hôpital Privé Saint Martin_Service de chirurgie digestive - Caen, France
- Hosp. Vithas Sevilla_Endocrino y Nutrición - Castilleja de la Cuesta, Spain
- Hospital Naval Ferrol - Ferrol, Spain
- Universitair Ziekenhuis Gent - Ghent, Belgium
- AIPSMC - DiMed EOOD - Haskovo, Bulgaria
- Gentofte Hospital - Center for Klinisk Metabolisk Forskning - Hellerup, Denmark
- Regionshospitalet Gødstrup, Hjertesygdomme - Herning, Denmark
- City Hospital Kliniki Monoprosopi I.K.E. - Kalamata, Greece
- KORMONT - Kluisbergen, Belgium
- LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie - Le Coudray, France
- Hôpital Privé La Louvière_Service de chirurgie - Lille, France
- Santa Sp. z o.o. - Lodz, Poland
- Medical Center Zdrave Lom EOOD - Lom, Bulgaria
- Clínica Palacios Madrid - Madrid, Spain
- Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit - Marousi, Greece
- CTC GoCo Mölndal - Mölndal, Sweden
- Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department - Peristeri, Greece
- IPMC - Dr. Elizabeta Dimitrova - Petrich, Bulgaria
- Centrum Zdrowia Metabolicznego Paweł Bogdański - Poznan, Poland
- Clínica Gaias Santiago - Santiago de Compostela, Spain
- Clínica Nuevas Tecnologías en Diabetes y Endocrinología - Seville, Spain
- H. Infanta Luisa_Endocrino y Obesidad - Seville, Spain
- MHAT Hadzhi Dimitar OOD - Sliven, Bulgaria
- DCC Neoklinik EAD - Sofia, Bulgaria
- Velocity Nova Sp. z o.o. - Staszów, Poland
- CTC Stockholm - Stockholm, Sweden
- NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes - Thessaloniki, Greece
- Thermi Clinic S.A. - Diabetes and Internal Medicine Department - Thessaloniki, Greece
- DCC 1 Velingrad EOOD - Velingrad, Bulgaria
- CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques - Vénissieux, France
- NBR Polska Tomasz Klodawski - Warsaw, Poland
- Care Access Polska Sp. Z o.o. - Warsaw, Poland
- FutureMeds Sp. z o.o. - Warsaw, Poland
- Praktijk Dokters van Nederhoven - Zwijndrecht, Netherlands
- Progress Clinical Research Zwolle - Zwolle, Netherlands
Showing 60 of 62 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →