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Effect of water volume and fasting on oral semaglutide blood levels in healthy participants (type 2 diabetes)

InvestigationalNo placebo
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What is this trial about?

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

The study looks at a drug called semaglutide, which is taken as a tablet and is used for people with Type 2 Diabetes. The medication works by helping the body control blood sugar levels. In this research, healthy volunteers will receive the tablet in two different strengths, 1.5 mg and 4 mg, to see how the drug behaves in the body.

The purpose of the study is to compare how the amount of water taken with the tablet and the length of the fasting period after taking it affect the drug’s pharmacokinetics, or how it is absorbed, distributed, and cleared from the bloodstream. Participants will take the tablet once daily for ten days, following the specific water and fasting instructions for each part of the study, and will have blood samples taken to measure the amount of medication in their blood. The study does not involve any additional treatments beyond the oral semaglutide tablets.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Consent

    You will be asked to read information about the study and sign a consent form that confirms you agree to take part.

    The study will involve healthy participants who have type 2 diabetes.

  2. Step 2

    Baseline Assessments

    Before any medication is taken, you will undergo basic health checks such as blood pressure measurement and a blood test.

    These assessments establish your starting health status for comparison with later results.

  3. Step 3

    Receive Study Medication and Instructions

    You will be given tablets of semaglutide in one of two strengths: 1.5 mg or 4 mg, to be taken by mouth.

    The tablet must be swallowed whole with a specified amount of water, and you will be told exactly how much water to use.

    After taking the tablet you must remain without food or drink for a set fasting period, as instructed, to ensure consistent absorption of the medicine.

  4. Step 4

    Daily Dosing for Ten Days

    You will take one tablet each day for a total of 10 days.

    Each dose is taken at the same time each day, with the required amount of water, followed by the prescribed fasting period.

    No other medication containing semaglutide will be taken during this time.

  5. Step 5

    Day Ten Blood Sampling

    On the tenth day after the last dose, a blood sample will be drawn to measure the level of semaglutide in your bloodstream.

    This sample helps determine how much of the medicine was absorbed and how quickly it reached its highest concentration.

  6. Step 6

    Final Assessments and Study Completion

    After the blood sample, you will undergo a brief health check similar to the baseline assessments.

    All study tablets will be returned, and the study will be considered complete for you.

Who can join the trial?

4 criteria

  • Must be a male participant.
  • Must be a healthy volunteer, meaning you have no significant medical problems.
  • Body mass index (BMI) must be between 18.5 and 29.9 kilograms per square meter. BMI is a simple calculation that compares your weight to your height.
  • You must be judged as generally healthy after a review of your medical history, a physical examination, and the results of vital signs (such as blood pressure and heart rate), an electrocardiogram (ECG) (a test that records the heart’s electrical activity), and routine clinical laboratory tests (blood and urine tests). The study doctor (investigator) will make this decision.

Who cannot join the trial?

5 criteria

  • Having a blood‑sugar test result called HbA1c that is 6.5 % or higher at the screening visit. (HbA1c shows the average level of sugar in the blood over the past 2–3 months.)
  • Using any tobacco or nicotine products, such as smoking more than 5 cigarettes a day, or not being willing to stop smoking and nicotine substitutes for at least 48 hours before and during the study stay.
  • Having a stomach or intestinal problem that could significantly affect how the drug is absorbed, as judged by the doctor. (Gastrointestinal disorders are conditions that affect the stomach, intestines, or related organs.)
  • Having a personal or first‑degree family history (parent, sibling, or child) of either multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. (Multiple endocrine neoplasia type 2 is a rare inherited condition that can cause tumors in hormone‑producing glands; medullary thyroid carcinoma is a specific type of thyroid cancer.)
  • Having had major stomach surgery that could affect drug absorption, such as removal of part or all of the stomach (subtotal or total gastrectomy), a sleeve‑shaped stomach reduction (sleeve gastrectomy), or a weight‑loss bypass operation (gastric bypass), or currently having any stomach or intestinal implant device.
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Investigated drugs

  • Semaglutide D

    is an oral tablet that contains semaglutide, a medicine that works like a natural hormone in the body to help control blood sugar levels. In this study, participants take the tablet once a day for ten days. The researchers are looking at how the amount of water taken with the tablet and the length of time a participant waits before eating after taking it can change how much of the medicine gets into the bloodstream.

  • Semaglutide D

    is the same oral tablet used in the trial, but participants receive it at a higher dose. The purpose of using the higher dose is to see if the same water‑volume and fasting rules affect the medicine’s absorption in the same way as the lower dose. This helps scientists understand the best way to take the medication for reliable blood‑sugar control.

What is already known about the treatment

  • Semaglutide D 1.5 mg

    This medication comes as an oral tablet that is swallowed with a small amount of water. It is an approved drug that has been studied in many clinical trials and is used in everyday medical practice. The tablet is mainly used to help control blood sugar in people with type 2 diabetes. It works by acting like a natural hormone called GLP‑1, which tells the pancreas to release insulin and reduces how much sugar the liver makes; it belongs to the class of GLP‑1 receptor agonists.

  • Semaglutide D 4 mg

    This medication is also an oral tablet taken with water, but at a higher strength. It is an approved, well‑researched drug that is already on the market for diabetes care. The higher‑dose tablet is intended to improve blood‑sugar control in adults with type 2 diabetes. Like the lower dose, it mimics the GLP‑1 hormone to increase insulin release and lower liver sugar production, and it is classified as a GLP‑1 receptor agonist.

Investigated diseases

Type 2 diabetes - A chronic condition in which the body’s cells become less responsive to insulin, causing blood‑sugar levels to rise. Over time the pancreas tries to produce more insulin, but eventually its ability to secrete insulin declines. The disease usually develops slowly, often beginning with mild elevations in glucose that progress to higher levels. As glucose remains elevated, symptoms such as increased thirst, frequent urination, and fatigue may appear and become more noticeable.
Trial detailsLast updated 27 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503949-65-00Protocol codeNN9924-4977Estimated enrolment120 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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