A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times

May 11, 2023 updated by: Novo Nordisk A/S

Oral Semaglutide Pharmacokinetics in Healthy Subjects, Effect of Dosing Schedules

The goal of this trial is to find out whether taking semaglutide tablets at different times before and after eating has a similar effect compared to the recommended dosing time. Participants with type 2 diabetes are recommended to take semaglutide on an empty stomach, and they should not eat, drink, or take any oral medicine for at least 30 minutes after that. The trial will look at how different dosing times of semaglutide before and after eating a meal changes how much semaglutide participants get into their blood. Participants will get one semaglutide tablet daily for a total of 10 days. For the first 5 days participants will receive semaglutide tablets of 3 mg and for the next 5 days, participants will receive semaglutide tablets of 7 mg. From here onwards, semaglutide tablets will be referred to as the 'trial medicine', unless specifically mentioned. Participants will get the trial medicine (3 mg and 7 mg) under one of the 5 following dosing conditions. It will be decided by chance under which dosing condition participants will receive the trial medicine: A 2 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm A), A 4 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm B), A 6 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm C), A 2 hour fast before taking the trial medicine and an overnight fast (at least 6 hours fast) after taking the trial medicine (Test arm D), An overnight fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Reference arm E). Before each fasting period prior to receiving the trial medicine, participants will fast for 4 hours and then receive a standardised meal. The meal should be completed before the 2, 4 or 6 hours fasting is started. The trial will last for about 48 to 78 days (about 1.5 to 2.5 months). Participants will have 4 scheduled visits with the study doctor. At one of the visits, participants will be admitted to the trial unit and have to stay for 12 consecutive days. At all visits participants will meet with trial staff and will have blood tests along with other clinical checks and tests. Participants will be asked about their health, medical history, and habits. Women only: Women cannot take part if pregnant, breast-feeding, or planning to become pregnant during the trial period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female, aged 18-64 years (both inclusive) at time of signing informed consent.
  • Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive).
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

  • Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.

  • Use of tobacco and nicotine products, defined as any of the below:

    • Smoking more than 5 cigarettes or the equivalent per day
    • Not willing to refrain from smoking and use of nicotine substitute products during the in-house period.
  • Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by subject or reported in the medical records).
  • Presence or history (as declared by subject or reported in the medical records) of pancreatitis (acute or chronic).
  • History (as declared by subject or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oral Semaglutide A
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 2 hours of the pre-dose fast, followed by a 30 minutes post-dose fast.
Drug: Oral Semaglutide
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).
Experimental: Oral Semaglutide B
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 4 hours of the pre-dose fast, followed by a 30 minutes post-dose fast.
Drug: Oral Semaglutide
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).
Experimental: Oral Semaglutide C
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-specified timing for 6 hours of the pre-dose fast, followed by a 30 minutes post-dose fast.
Drug: Oral Semaglutide
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).
Experimental: Oral Semaglutide D
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days), with a pre-dose fasting time of 2 hours followed by a post-dose overnight fast.
Drug: Oral Semaglutide
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).
Active Comparator: Oral Semaglutide E
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days). Participants will be instructed to take the trial product in the morning after an overnight fast and wait 30 minutes before taking any food, water or other oral medication in accordance with the approved dosing schedule for oral semaglutide.
Drug: Oral Semaglutide
Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area under the semaglutide plasma concentration - time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,day10)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
nmol*h/L
From 0 to 24 hours after the 10th dosing (day 10)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed semaglutide plasma concentration after the 10th dosing (Cmax,0-24h,sema,day10)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
nmol/L
From 0 to 24 hours after the 10th dosing (day 10)
Time to maximum observed semaglutide plasma concentration after the 10th dosing (tmax,0-24h,sema,day10)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
hours (h)
From 0 to 24 hours after the 10th dosing (day 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Reporting Anchor and Disclosure 1452, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9924-4556
  • U1111-1243-9641 (Other Identifier: World Health Organization (WHO))
  • 2019-004569-42 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings