Recruiting
Phase 3

Semaglutide

Sponsor:

Novo Nordisk A/S

Code:

NCT07770841

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Placebo

Study Details

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

Study ID

NCT07770841

Start date

Aug 12, 2026

Status verified date

Sep, 2026

Completion date

Apr 11, 2028

Anticipated

Primary completion date

Feb 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Semaglutide

Participants will receive semaglutide orally.

Placebo

Participants will receive placebo orally.

Primary outcome measure

  • Relative change in body weight [ Time Frame: From baseline (week 0) to week 60 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Uni of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35296

Headlands Research California, LLC

Recruiting

Escondido, California, United States, 92025

National Research Institute - Huntington Park

Recruiting

Huntington Park, California, United States, 90255

Los Angeles Institute for Metabolic Research

Recruiting

Los Angeles, California, United States, 90015

ERG Holding Company, LLC / Evolution Research Group, LLC

Recruiting

Delray Beach, Florida, United States, 33445

ERG Holding Company, LLC / Evolution Research Group, LLC

Recruiting

Fort Myers, Florida, United States, 33192

Jedidiah Clinical Research

Recruiting

Tampa, Florida, United States, 33619

East West Med Res Inst

Recruiting

Honolulu, Hawaii, United States, 96814

L-MARC Research Center

Recruiting

Louisville, Kentucky, United States, 40213

StudyMetrix Research LLC

Recruiting

City of Saint Peters, Missouri, United States, 63303

Jubilee Clinical Research, Inc.

Recruiting

Las Vegas, Nevada, United States, 89106

Corvallis Clinic PC Clinical Research Department

Recruiting

Corvallis, Oregon, United States, 97330-3737

Spartanburg Medical Research

Recruiting

Spartanburg, South Carolina, United States, 29303

Cedar Health Research

Recruiting

Dallas, Texas, United States, 75251

Selma Medical Associates

Recruiting

Winchester, Virginia, United States, 22601-3834

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-09.