Oral semaglutide for weight loss in adults who are overweight or have obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares oral semaglutide at lower doses to placebo in adults with excess body weight. Eligible participants have BMI ≥27 with at least one weight-related condition or BMI ≥30, and a history of trying to lose weight with diet. The study will identify the most effective lower dose to support weight loss while monitoring safety. It uses a randomized, placebo-controlled design to assess weight change over a defined period. Lead sponsor is Novo Nordisk, with sites in Alabama and California.

Why it matters

Who can join: the full rules

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.

Where it's running

• Uni of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Headlands Research California, LLC
  Escondido, California, United States Recruiting
• National Research Institute - Huntington Park
  Huntington Park, California, United States Recruiting
• Los Angeles Institute for Metabolic Research
  Los Angeles, California, United States Recruiting
• ERG Holding Company, LLC / Evolution Research Group, LLC
  Delray Beach, Florida, United States Recruiting
• ERG Holding Company, LLC / Evolution Research Group, LLC
  Fort Myers, Florida, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.