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NCT07770841PHASE3Recruiting

Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight

Novo Nordisk A/S

Start Date

8/12/2026

Completion Date

4/11/2028

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Semaglutide

DRUG

Placebo

Interested in This Trial?

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Conditions

OverweightObesity

Locations

Uni of Alabama at Birmingham

Birmingham, Alabama 35296

United States

Headlands Research California, LLC

Escondido, California 92025

United States

National Research Institute - Huntington Park

Huntington Park, California 90255

United States

Los Angeles Institute for Metabolic Research

Los Angeles, California 90015

United States

ERG Holding Company, LLC / Evolution Research Group, LLC

Delray Beach, Florida 33445

United States

ERG Holding Company, LLC / Evolution Research Group, LLC

Fort Myers, Florida 33192

United States

Jedidiah Clinical Research

Tampa, Florida 33619

United States

East West Med Res Inst

Honolulu, Hawaii 96814

United States

L-MARC Research Center

Louisville, Kentucky 40213

United States

StudyMetrix Research LLC

City of Saint Peters, Missouri 63303

United States

Jubilee Clinical Research, Inc.

Las Vegas, Nevada 89106

United States

Corvallis Clinic PC Clinical Research Department

Corvallis, Oregon 97330-3737

United States

UPA Ctr Weight and Eating Dis

Philadelphia, Pennsylvania 19104

United States

Spartanburg Medical Research

Spartanburg, South Carolina 29303

United States

Cedar Health Research

Dallas, Texas 75251

United States

Selma Medical Associates

Winchester, Virginia 22601-3834

United States

Anima Research Center

Alken, 3570

Belgium

Imelda

Bonheiden, 2820

Belgium

UZ Brussel - Universitair Ziekenhuis Brussel

Brussels, 1090

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

KORMONT

Kluisbergen, 9690

Belgium

AIPSMC - DiMed EOOD

Haskovo, 6300

Bulgaria

Medical Center Zdrave Lom EOOD

Lom, 3600

Bulgaria

IPMC - Dr. Elizabeta Dimitrova

Petrich, 2850

Bulgaria

MHAT Hadzhi Dimitar OOD

Sliven, 8800

Bulgaria

DCC Neoklinik EAD

Sofia, 1408

Bulgaria

DCC 1 Velingrad EOOD

Velingrad, 4600

Bulgaria

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus N, 8200

Denmark

Gentofte Hospital - Center for Klinisk Metabolisk Forskning

Hellerup, 2900

Denmark

Regionshospitalet Gødstrup, Hjertesygdomme

Herning, 7400

Denmark

Hôpital Privé Saint Martin_Service de chirurgie digestive

Caen, 14000

France

LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie

Le Coudray, 28630

France

Hôpital Privé La Louvière_Service de chirurgie

Lille, 59800

France

CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques

Vénissieux, 69200

France

City Hospital Kliniki Monoprosopi I.K.E.

Kalamata, 24100

Greece

Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit

Marousi, 15125

Greece

Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department

Peristeri, 121 31

Greece

NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes

Thessaloniki, 54635

Greece

Thermi Clinic S.A. - Diabetes and Internal Medicine Department

Thessaloniki, 57001

Greece

Progress Clinical Research Amsterdam

Amsterdam, 1081 GN

Netherlands

Praktijk Dokters van Nederhoven

Zwijndrecht, 3334 SB

Netherlands

Progress Clinical Research Zwolle

Zwolle, 8025 AZ

Netherlands

Kresmed Sp. z o. o.

Bialystok, 15-481

Poland

Athleticomed Sp. z o.o.

Bydgoszcz, 85-752

Poland

Gierach-Med

Bygdoszcz, 85-796

Poland

Santa Sp. z o.o.

Lodz, 90-302

Poland

Centrum Zdrowia Metabolicznego Paweł Bogdański

Poznan, 60-589

Poland

Velocity Nova Sp. z o.o.

Staszów, 28-200

Poland

NBR Polska Tomasz Klodawski

Warsaw, 00-710

Poland

Care Access Polska Sp. Z o.o.

Warsaw, 00-719

Poland

FutureMeds Sp. z o.o.

Warsaw, 03-291

Poland

HU de Fuenlabrada_Endocrinología

Fuenlabrada, Madrid 28042

Spain

CPE Bola Azul_Endocrinología y Nutrición

Almería, 04009

Spain

Hosp. Vithas Sevilla_Endocrino y Nutrición

Castilleja de la Cuesta, 41950

Spain

Hospital Naval Ferrol

Ferrol, 15405

Spain

Clínica Palacios Madrid

Madrid, 28009

Spain

Clínica Gaias Santiago

Santiago de Compostela, 15702

Spain

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003

Spain

H. Infanta Luisa_Endocrino y Obesidad

Seville, 41010

Spain

CTC GoCo Mölndal

Mölndal, 431 53

Sweden

Enheten för Kliniska Studier (EKS), Örebro

Örebro, 703 62

Sweden

CTC Stockholm

Stockholm, 171 64

Sweden