Efficacy and Safety of Once Daily Oral Semaglutide in Adults With Overweight or Obesity
Status: Recruiting
Location: See all (62) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
‣ OR
⁃ ≥ 30.0 kg/m\^2.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.
Locations
United States
Alabama
Uni of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
California
Headlands Research California, LLC
NOT_YET_RECRUITING
Escondido
National Research Institute - Huntington Park
NOT_YET_RECRUITING
Huntington Park
Los Angeles Institute for Metabolic Research
NOT_YET_RECRUITING
Los Angeles
Florida
ERG Holding Company, LLC / Evolution Research Group, LLC
NOT_YET_RECRUITING
Delray Beach
ERG Holding Company, LLC / Evolution Research Group, LLC
NOT_YET_RECRUITING
Fort Myers
Jedidiah Clinical Research
NOT_YET_RECRUITING
Tampa
Hawaii
East West Med Res Inst
NOT_YET_RECRUITING
Honolulu
Kentucky
L-MARC Research Center
NOT_YET_RECRUITING
Louisville
Missouri
StudyMetrix Research LLC
NOT_YET_RECRUITING
City Of Saint Peters
Nevada
Jubilee Clinical Research, Inc.
NOT_YET_RECRUITING
Las Vegas
Oregon
Corvallis Clinic PC Clinical Research Department
NOT_YET_RECRUITING
Corvallis
Pennsylvania
UPA Ctr Weight and Eating Dis
NOT_YET_RECRUITING
Philadelphia
South Carolina
Spartanburg Medical Research
NOT_YET_RECRUITING
Spartanburg
Texas
Cedar Health Research
NOT_YET_RECRUITING
Dallas
Virginia
Selma Medical Associates
NOT_YET_RECRUITING
Winchester
Other Locations
Belgium
Anima Research Center
RECRUITING
Alken
Imelda
NOT_YET_RECRUITING
Bonheiden
UZ Brussel - Universitair Ziekenhuis Brussel
NOT_YET_RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
KORMONT
RECRUITING
Kluisbergen
Bulgaria
AIPSMC - DiMed EOOD
RECRUITING
Haskovo
Medical Center Zdrave Lom EOOD
RECRUITING
Lom
IPMC - Dr. Elizabeta Dimitrova
NOT_YET_RECRUITING
Petrich
MHAT Hadzhi Dimitar OOD
RECRUITING
Sliven
DCC Neoklinik EAD
RECRUITING
Sofia
DCC 1 Velingrad EOOD
RECRUITING
Velingrad
Denmark
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
RECRUITING
Aarhus N
Gentofte Hospital - Center for Klinisk Metabolisk Forskning
RECRUITING
Hellerup
Regionshospitalet Gødstrup, Hjertesygdomme
RECRUITING
Herning
France
Hôpital Privé Saint Martin_Service de chirurgie digestive
NOT_YET_RECRUITING
Caen
LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie
NOT_YET_RECRUITING
Le Coudray
Hôpital Privé La Louvière_Service de chirurgie
NOT_YET_RECRUITING
Lille
CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques
NOT_YET_RECRUITING
Vénissieux
Greece
City Hospital Kliniki Monoprosopi I.K.E.
NOT_YET_RECRUITING
Kalamata
Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
RECRUITING
Marousi
Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
RECRUITING
Peristeri
NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
RECRUITING
Thessaloniki
Thermi Clinic S.A. - Diabetes and Internal Medicine Department
RECRUITING
Thessaloniki
Netherlands
Progress Clinical Research Amsterdam
NOT_YET_RECRUITING
Amsterdam
Praktijk Dokters van Nederhoven
NOT_YET_RECRUITING
Zwijndrecht
Progress Clinical Research Zwolle
NOT_YET_RECRUITING
Zwolle
Poland
Kresmed Sp. z o. o.
NOT_YET_RECRUITING
Bialystok
Athleticomed Sp. z o.o.
NOT_YET_RECRUITING
Bydgoszcz
Gierach-Med
NOT_YET_RECRUITING
Bygdoszcz
Santa Sp. z o.o.
NOT_YET_RECRUITING
Lodz
Centrum Zdrowia Metabolicznego Paweł Bogdański
NOT_YET_RECRUITING
Poznan
Velocity Nova Sp. z o.o.
NOT_YET_RECRUITING
Staszów
Care Access Polska Sp. Z o.o.
NOT_YET_RECRUITING
Warsaw
FutureMeds Sp. z o.o.
NOT_YET_RECRUITING
Warsaw
NBR Polska Tomasz Klodawski
NOT_YET_RECRUITING
Warsaw
Spain
Centro Periferico De Especialidades Bola Azul
NOT_YET_RECRUITING
Almería
Hospital Vithas Sevilla
NOT_YET_RECRUITING
Castilleja De La Cuesta
Hospital Naval Ferrol
NOT_YET_RECRUITING
Ferrol
HU de Fuenlabrada_Endocrinología
NOT_YET_RECRUITING
Fuenlabrada
Clínica Palacios Madrid
NOT_YET_RECRUITING
Madrid
Clínica Gaias Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
NOT_YET_RECRUITING
Seville
H. Infanta Luisa_Endocrino y Obesidad
NOT_YET_RECRUITING
Seville
Sweden
CTC GoCo Mölndal
RECRUITING
Mölndal
Enheten för Kliniska Studier (EKS), Örebro
RECRUITING
Örebro
CTC Stockholm
RECRUITING
Stockholm
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2026-08-12
Estimated Completion Date: 2028-04-11
Participants
Target number of participants: 450
Treatments
Experimental: Semaglutide
Participants will receive two different oral doses of semaglutide as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo_comparator: Placebo
Participants will receive oral dose of placebo as an adjunct to a reduced-calorie diet and increased physical activity.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S