Taking people in United StatesPhase 3
Tests oral semaglutide tablets for weight loss in adults with excess weight
Compares lower doses of oral semaglutide with placebo tablets in adults with overweight or obesity.
Key facts
- Who runs it
- Novo Nordisk A/S
- Where
- Birmingham, City of Saint Peters, Corvallis, Dallas, Delray Beach, Escondido, Fort Myers, Honolulu, Huntington Park, Las Vegas, Los Angeles, Louisville, Philadelphia, Spartanburg, Tampa, and Winchester, United StatesSee the 16 sitesAlso in 9 other countries, 45 sites
- Trial code
- NCT07770841
- EU 2025-524626-18-00
- U1111-1331-5612
- Registry title
- Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 450 people, planned
- Started
- 12 Aug 2026
- Expected to end
- 11 Apr 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Semaglutide
- Placebo
- Record updated
- 9 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with overweight or obesity who have tried to lose weight by diet before. It tests lower doses of oral semaglutide against dummy tablets.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Body mass index (BMI) of 30.0 kg/m^2 or more, or BMI of 27.0 kg/m^2 or more with at least one weight-related health problem such as high blood pressure, abnormal blood fats, sleep apnoea or heart and blood vessel disease.
- Earlier treatment
- At least one self-reported unsuccessful diet effort to lose weight. People who have consistently used GLP-1 receptor agonists or amylin analogues before screening cannot join.
- Biomarker or test result
- HbA1c must be below 6.5% (48 mmol/mol) at screening.
Main reasons for not taking part
- Body weight changed by more than 5% in the 90 days before screening
- HbA1c of 6.5% (48 mmol/mol) or higher at screening
- Consistent use of GLP-1 receptor agonists, including dual GLP-1/GIP medicines, or amylin analogues before screening
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- A self-reported change in body weight greater than (>) 5% within 90 days before screening irrespective of medical records
- 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
- HbA1c ≥ 6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening
Where in United States
Also in 9 other countries, 45 sites
- Uni of Alabama at BirminghamBirmingham, United StatesContact: Novo NordiskTaking people
- StudyMetrix Research, LLCCity of Saint Peters, United StatesContact: Novo NordiskTaking people
- Corvallis Clinic PC Clinical Research DepartmentCorvallis, United StatesContact: Novo NordiskTaking people
- Cedar Health ResearchDallas, United StatesContact: Novo NordiskTaking people
- ERG Holding Company, LLC / Evolution Research Group, LLCDelray Beach, United StatesContact: Novo NordiskTaking people
- Headlands Research California, LLCEscondido, United StatesContact: Novo NordiskTaking people
- ERG Holding Company, LLC / Evolution Research Group, LLCFort Myers, United StatesContact: Novo NordiskTaking people
- East West Med Res InstHonolulu, United StatesContact: Novo NordiskTaking people
- National Research Institute - Huntington ParkHuntington Park, United StatesContact: Novo NordiskTaking people
- Jubilee Clinical Research, Inc.Las Vegas, United StatesContact: Novo NordiskTaking people
- Los Angeles Institute for Metabolic ResearchLos Angeles, United StatesContact: Novo NordiskTaking people
- L-MARC Research CenterLouisville, United StatesContact: Novo NordiskTaking people
- UPA Ctr Weight and Eating DisPhiladelphia, United StatesContact: Novo NordiskNot yet recruiting
- Spartanburg Medical ResearchSpartanburg, United StatesContact: Novo NordiskTaking people
- Jedidiah Clinical ResearchTampa, United StatesContact: Novo NordiskTaking people
- Selma Medical AssociatesWinchester, United StatesContact: Novo NordiskTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- SemaglutideTreatment being tested
Participants will receive two different oral doses of semaglutide as an adjunct to a reduced-calorie diet and increased physical activity.
- PlaceboPlacebo, for comparison
Participants will receive oral dose of placebo as an adjunct to a reduced-calorie diet and increased physical activity.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Efficacy and Safety of Once Daily Oral Semaglutide in Adults With Overweight or Obesity
- Plain-language title
- Tests oral semaglutide tablets for weight loss in adults with excess weightGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 September 2026