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

NCT07770841

RecruitingPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Overweight, Obesity

Interventions: Semaglutide, Placebo

Countries: United States, Belgium, Bulgaria, Denmark, France, Greece, Netherlands, Poland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (62)
  • Birmingham, Alabama, United States
  • Escondido, California, United States
  • Huntington Park, California, United States
  • Los Angeles, California, United States
  • Delray Beach, Florida, United States
  • Fort Myers, Florida, United States
  • Tampa, Florida, United States
  • Honolulu, Hawaii, United States
  • Louisville, Kentucky, United States
  • City of Saint Peters, Missouri, United States
  • Las Vegas, Nevada, United States
  • Corvallis, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Spartanburg, South Carolina, United States
  • Dallas, Texas, United States
  • Winchester, Virginia, United States
  • Alken, Belgium
  • Bonheiden, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Kluisbergen, Belgium
  • Haskovo, Bulgaria
  • Lom, Bulgaria
  • Petrich, Bulgaria
  • Sliven, Bulgaria
  • Sofia, Bulgaria
  • Velingrad, Bulgaria
  • Aarhus N, Denmark
  • Hellerup, Denmark
  • Herning, Denmark
  • + 32 more on CT.gov