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

NCT07770841 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9932-8687U1111-1331-56122025-524626-18
• Study Type: interventional
• Target: 450
• Locations: 10 countries
• Sites: 62

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in body weight

  Measured as percentage change in body weight.

  From baseline (week 0) to week 60

Secondary Outcomes (22)

• Achievement of body weight reduction greater than or equal to (≥) 5 percentage (%) (Yes/No)

  At week 60

• Achievement of body weight reduction ≥ 10% (Yes/No)

  At week 60

• Achievement of body weight reduction ≥ 15% (Yes/No)

  At week 60

• Change in waist circumference

  From baseline (week 0) to week 60

• Change in body weight

  From baseline (week 0) to week 60

Study Arms (2)

Semaglutide

EXPERIMENTAL

Participants will receive two different oral doses of semaglutide as an adjunct to a reduced-calorie diet and increased physical activity.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants will receive oral dose of placebo as an adjunct to a reduced-calorie diet and increased physical activity.

Drug: Placebo

Interventions

Semaglutide DRUG

Participants will receive semaglutide orally.

Semaglutide

Placebo DRUG

Participants will receive placebo orally.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (62)

Uni of Alabama at Birmingham

Birmingham, Alabama, 35296, United States

NOT YET RECRUITING

Headlands Research California, LLC

Escondido, California, 92025, United States

NOT YET RECRUITING

National Research Institute - Huntington Park

Huntington Park, California, 90255, United States

NOT YET RECRUITING

Los Angeles Institute for Metabolic Research

Los Angeles, California, 90015, United States

NOT YET RECRUITING

ERG Holding Company, LLC / Evolution Research Group, LLC

Delray Beach, Florida, 33445, United States

NOT YET RECRUITING

ERG Holding Company, LLC / Evolution Research Group, LLC

Fort Myers, Florida, 33192, United States

NOT YET RECRUITING

Jedidiah Clinical Research

Tampa, Florida, 33619, United States

NOT YET RECRUITING

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

NOT YET RECRUITING

L-MARC Research Center

Louisville, Kentucky, 40213, United States

NOT YET RECRUITING

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

NOT YET RECRUITING

Jubilee Clinical Research, Inc.

Las Vegas, Nevada, 89106, United States

NOT YET RECRUITING

Corvallis Clinic PC Clinical Research Department

Corvallis, Oregon, 97330-3737, United States

NOT YET RECRUITING

UPA Ctr Weight and Eating Dis

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

NOT YET RECRUITING

Cedar Health Research

Dallas, Texas, 75251, United States

NOT YET RECRUITING

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

NOT YET RECRUITING

Anima Research Center

Alken, 3570, Belgium

RECRUITING

Imelda

Bonheiden, 2820, Belgium

NOT YET RECRUITING

UZ Brussel - Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

KORMONT

Kluisbergen, 9690, Belgium

RECRUITING

AIPSMC - DiMed EOOD

Haskovo, 6300, Bulgaria

RECRUITING

Medical Center Zdrave Lom EOOD

Lom, 3600, Bulgaria

RECRUITING

IPMC - Dr. Elizabeta Dimitrova

Petrich, 2850, Bulgaria

NOT YET RECRUITING

MHAT Hadzhi Dimitar OOD

Sliven, 8800, Bulgaria

RECRUITING

DCC Neoklinik EAD

Sofia, 1408, Bulgaria

RECRUITING

DCC 1 Velingrad EOOD

Velingrad, 4600, Bulgaria

RECRUITING

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

RECRUITING

Gentofte Hospital - Center for Klinisk Metabolisk Forskning

Hellerup, 2900, Denmark

RECRUITING

Regionshospitalet Gødstrup, Hjertesygdomme

Herning, 7400, Denmark

RECRUITING

Hôpital Privé Saint Martin_Service de chirurgie digestive

Caen, 14000, France

NOT YET RECRUITING

LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie

Le Coudray, 28630, France

NOT YET RECRUITING

Hôpital Privé La Louvière_Service de chirurgie

Lille, 59800, France

NOT YET RECRUITING

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

Vénissieux, 69200, France

NOT YET RECRUITING

City Hospital Kliniki Monoprosopi I.K.E.

Kalamata, 24100, Greece

NOT YET RECRUITING

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

Marousi, 15125, Greece

RECRUITING

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

Peristeri, 121 31, Greece

RECRUITING

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

Thessaloniki, 54635, Greece

RECRUITING

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

Thessaloniki, 57001, Greece

RECRUITING

Progress Clinical Research Amsterdam

Amsterdam, 1081 GN, Netherlands

NOT YET RECRUITING

Praktijk Dokters van Nederhoven

Zwijndrecht, 3334 SB, Netherlands

NOT YET RECRUITING

Progress Clinical Research Zwolle

Zwolle, 8025 AZ, Netherlands

NOT YET RECRUITING

Kresmed Sp. z o. o.

Bialystok, 15-481, Poland

NOT YET RECRUITING

Athleticomed Sp. z o.o.

Bydgoszcz, 85-752, Poland

NOT YET RECRUITING

Gierach-Med

Bygdoszcz, 85-796, Poland

NOT YET RECRUITING

Santa Sp. z o.o.

Lodz, 90-302, Poland

NOT YET RECRUITING

Centrum Zdrowia Metabolicznego Paweł Bogdański

Poznan, 60-589, Poland

NOT YET RECRUITING

Velocity Nova Sp. z o.o.

Staszów, 28-200, Poland

NOT YET RECRUITING

NBR Polska Tomasz Klodawski

Warsaw, 00-710, Poland

NOT YET RECRUITING

Care Access Polska Sp. Z o.o.

Warsaw, 00-719, Poland

NOT YET RECRUITING

FutureMeds Sp. z o.o.

Warsaw, 03-291, Poland

NOT YET RECRUITING

HU de Fuenlabrada_Endocrinología

Fuenlabrada, Madrid, 28042, Spain

NOT YET RECRUITING

Centro Periferico De Especialidades Bola Azul

Almería, 04009, Spain

NOT YET RECRUITING

Hospital Vithas Sevilla

Castilleja de la Cuesta, 41950, Spain

NOT YET RECRUITING

Hospital Naval Ferrol

Ferrol, 15405, Spain

NOT YET RECRUITING

Clínica Palacios Madrid

Madrid, 28009, Spain

NOT YET RECRUITING

Clínica Gaias Santiago

Santiago de Compostela, 15702, Spain

NOT YET RECRUITING

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003, Spain

NOT YET RECRUITING

H. Infanta Luisa_Endocrino y Obesidad

Seville, 41010, Spain

NOT YET RECRUITING

CTC GoCo Mölndal

Mölndal, 431 53, Sweden

RECRUITING

Enheten för Kliniska Studier (EKS), Örebro

Örebro, 701 85, Sweden

RECRUITING

CTC Stockholm

Stockholm, 171 64, Sweden

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: August 12, 2026
• Primary Completion (Estimated): February 22, 2028
• Study Completion (Estimated): April 11, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (16); PL (9); NL (3); GR (5); FR (4); DK (3); ES (8); BU (6); BE (5); SE (3)