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Efficacy and safety of oral semaglutide for weight loss in adults with overweight or obesity

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have overweight or obesity, a condition where excess body weight can increase the risk of health problems such as high blood pressure and diabetes. The medication being tested is an oral form of semaglutide, sold under the brand name Rybelsus. Participants will receive either the active medication at different dose strengths or a dummy pill (placebo) once a day, in addition to following a reduced‑calorie diet and increasing physical activity.

The purpose of the study is to determine whether oral semaglutide leads to greater weight loss compared with the placebo when combined with diet and exercise. Participants will take the assigned tablet every day for several months, attend regular clinic visits where their weight, waist size, blood pressure, and blood tests are checked, and report any side effects. The study will track changes in body weight and related health measures over the course of the trial.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and baseline assessments

    After you join the study you will attend an initial visit where the study team will record your height, weight, waist size, and blood pressure.

    Blood samples will be taken to measure cholesterol, blood sugar, and other health markers.

  2. Step 2

    Receive study medication

    You will be given either a placebo tablet or an oral tablet containing semaglutide.

    The semaglutide tablets are available in strengths of 1.5 mg, 4 mg, or 9 mg; the specific strength is decided by the study randomization.

    You will be instructed to take one tablet each day by mouth, at the same time each day.

  3. Step 3

    Daily medication intake

    Each day you will swallow the tablet with a small amount of water, preferably on an empty stomach, and wait at least 30 minutes before eating or drinking anything other than water.

    The tablet is taken once daily for the entire duration of the trial as directed by the study team.

  4. Step 4

    Follow a reduced‑calorie diet and increase physical activity

    You will be asked to follow a diet that provides fewer calories than your usual intake, as explained by the study dietitian.

    You will also be encouraged to be more physically active, such as walking for at least 150 minutes each week.

  5. Step 5

    Regular follow‑up visits

    You will return to the study site at scheduled intervals (for example, every 4 to 8 weeks) for check‑ups.

    During each visit your weight, waist circumference, and blood pressure will be measured again.

    Additional blood samples may be taken to monitor cholesterol, blood sugar, and other safety markers.

  6. Step 6

    Report any side effects

    You will be asked to tell the study team about any new symptoms or health problems you experience.

    Common side effects may include nausea, stomach upset, or headache, but you should report any reaction, no matter how mild.

  7. Step 7

    Final assessment

    At the end of the trial you will have a final visit where all measurements taken during the study are repeated.

    The study team will collect information about your overall weight loss, changes in health markers, and any adverse events that occurred.

Who can join the trial?

6 criteria

  • You have signed a form that shows you agree to join the study, called informed consent, before any study procedures begin.
  • You are either female or male, based on the sex you were assigned at birth.
  • You are at least 18 years old when you sign the consent form.
  • Your body mass index (BMI) meets one of the following:
    • BMI of 27 or higher **and** you have at least one weight‑related health problem such as high blood pressure (hypertension), high cholesterol or fats in the blood (dyslipidaemia), breathing problems during sleep (obstructive sleep apnoea), or heart disease (cardiovascular disease); or
    • BMI of 30 or higher even if you do not have another health problem.
    • You have tried at least one diet on your own that did not succeed in helping you lose weight.

Who cannot join the trial?

3 criteria

  • If you have reported that your body weight changed by more than 5 % in the 90 days before the screening visit, you cannot take part, even if there is no medical record of the change.
  • If a blood test called HbA1c shows a level of 6.5 % or higher (this test measures your average blood sugar over the past 2–3 months), you cannot take part.
  • If you have used any medication that is prescribed for obesity or weight management within the 90 days before screening, or if you have regularly taken medicines that belong to the class called GLP-1 receptor agonists (drugs that act like a hormone that reduces appetite) or amylin analogues (drugs that affect how full you feel), you cannot take part.
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Investigated drugs

Rybelsus is an oral tablet that contains the medicine semaglutide. It is taken once a day by mouth and works by helping the body feel full sooner, which can lead to reduced food intake and weight loss. In this study, participants used Rybelsus together with other lifestyle changes to see how well it helps people who are overweight or have obesity lose weight.

The trial also included a lifestyle program that asked participants to follow a reduced‑calorie diet and increase their physical activity. This means they were guided to eat fewer calories than usual and to be more active each day, such as by walking, exercising, or other forms of movement. These changes were combined with the medication to evaluate their combined effect on weight loss.

What is already known about the treatment

  • Placebo for semaglutide D tablet

    This is an oral tablet that looks like the active drug but contains no medicine, so it is taken by swallowing with water like a normal pill. It is used only as a control in research studies and has no therapeutic effect. The placebo is not a marketed medication and is only described in clinical trial protocols. It does not belong to any drug class because it contains no active substance.

  • Rybelsus 1.5 mg tablets

    This medication is an oral tablet taken once a day with a glass of water, usually before a meal. Semaglutide, the active ingredient, is approved and widely used for type 2 diabetes and for helping people lose weight. It works by binding to a natural hormone that increases insulin release and reduces appetite, leading to lower blood sugar and weight loss. It is classified as a GLP‑1 receptor agonist, a type of drug that mimics the body’s own appetite‑controlling hormone.

  • Rybelsus 4 mg tablets

    This is an oral tablet taken once daily, swallowed with water and not crushed. The tablet contains semaglutide, a medicine that is already approved for diabetes and weight‑management treatment. It activates the same hormone pathway that raises insulin after meals and makes you feel fuller, helping to lower blood sugar and reduce weight. It belongs to the GLP‑1 receptor agonist drug class.

  • Rybelsus 9 mg tablets

    This medication is an oral tablet taken once each day with water, usually before eating. It contains semaglutide, which is an approved drug for controlling blood sugar in type 2 diabetes and for supporting weight loss. The drug works by stimulating the body’s natural hormone that increases insulin and curbs appetite, which helps lower glucose levels and promote weight reduction. It is categorized as a GLP‑1 receptor agonist.

Investigated diseases

Overweight and obesity - Overweight is defined as excess body weight relative to height, while obesity refers to a higher amount of body fat accumulation. Both conditions develop gradually when caloric intake consistently exceeds energy expenditure. Over time, excess calories are stored as fat, expanding subcutaneous and visceral fat depots. If the energy imbalance persists, weight typically progresses from overweight to obesity. The increase in fat mass can alter metabolic processes and affect the function of various organs. Lifestyle, genetic factors, and environmental influences all contribute to the ongoing accumulation of body weight.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524626-18-00Protocol codeNN9932-8687Estimated enrolment450 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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