A Research Study to Compare How Much Semaglutide is Found in the Blood With Different Tablets of Oral Semaglutide in Healthy Participants

March 27, 2024 updated by: Novo Nordisk A/S

A Randomised Study to Investigate Steady State Semaglutide Exposure of a New Formulation of Oral Semaglutide in Healthy Participants

In this study, a known investigational medicine called 'semaglutide' will be tested in 2 different tablet versions. In addition to semaglutide, the tablet versions contain different helping agents in different amounts. Both tablet versions have a helping agent called SNAC. The main aim of this study is to investigate semaglutide of 4 different doses in a new tablet by determining the amount of semaglutide in the blood and compare the concentration in the blood for the new tablet with the tablet currently investigated in a phase 3b study (current version). For this purpose, the amount of semaglutide in the blood will be measured after multiple doses of semaglutide, at different doses. Which doses participant will get will be decided by chance. The study will have 4 groups (A-D) and will include up to 260 participants. The doses participant get depends on the group they are (enrolled) in. All four groups will be receiving the investigational medicine for 15 weeks in total. Group A will start testing the dose level 1 (new tablet) for 5 weeks. Then receiving the current tablet of semaglutide C for 5 weeks and then testing the dose level 3 (new tablet) for 5 weeks. Group B will start receiving the current tablet semaglutide C for 5 weeks and then testing the dose level 2 (new tablet) in 5 weeks and dose level 4 (new tablet) in 5 weeks. Group C will start testing the dose level 1 (new tablet) and dose level 3 (new tablet) for 5 weeks each and then receiving the current tablet of semaglutide C (2x dose) for 5 weeks. Group D will start testing the dose level 2 (new tablet) for 5 weeks. Then receiving the current tablet of semaglutide C (2x dose) for 5 weeks and then testing the dose level 4 (new tablet) for 5 weeks. Participants will be receiving doses of semaglutide for 6 weeks before being assigned to one of the 4 groups (A-D) to reduce the risk of side effects. Participants cannot choose which group they want to be in, and they can only participate in one group in this study. Participant will get one tablet to be taken by mouth each day for approximately 21 weeks. The tablet should be taken in the morning together with no more than half a glass of water (120 milliliter [mL]), after an overnight fast of at least 6 hours (no food or drinks). Water is also not allowed from 2 hours before dosing. After dosing, participant must begin breakfast no earlier than 30 minutes and no later than 35 minutes after having taken tablet. The study will last for about 30 weeks in total for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (6 weeks), an investigational treatment period (15 weeks) and a follow-up period (5 weeks after last dose). The planned duration a participant can receive trial product is 21 weeks. Participant should not take any prescription or non-prescription medicines (including herbal products) within 14 days prior to the screening visit (visit 1) and until the follow-up visit, except for birth control, routine vitamins, medicines applied on the skin, and occasional use of acetaminophen or ibuprofen (a mild pain killer). No oral medication (medicine taken by mouth) can be taken from 2 hours before and until 30 minutes after each dosing with semaglutide. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • 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 Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3P 3P1
        • Altasciences Clinical Company, Inc
  • United States
    • California
      • Cypress, California, United States, 90630
        • Altasciences Clinical LA, Inc.

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

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive) at screening
  • 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:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • Use of prescription medicinal products or non-prescription drugs, except highly effective contraceptives, routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen within 14 days before screening
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs, as judged by the investigator

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A: Semaglutide J-Semaglutide C-Semaglutide J
After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide C once daily for next 4 weeks and thereafter semaglutide J at dose level 3 once daily for next 4 weeks.
Drug: Semaglutide J
Participants will receive oral semglutide J at dose level 1 and 3 in treatment sequence A and C; and at dose level 2 and 4 in treatment sequence B and D.
Drug: Semaglutide C
Participants will receive oral semglutide C in treatment sequence A and B; and at semglutide C at 2x dose level in treatment sequence C and D.
Experimental: Sequence B: Semaglutide C-Semaglutide J-Semaglutide J
After 6 weeks of run-in dose escalation period participants will orally receive semaglutide C once daily for 4 weeks followed by semaglutide J at dose level 2 once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks.
Drug: Semaglutide J
Participants will receive oral semglutide J at dose level 1 and 3 in treatment sequence A and C; and at dose level 2 and 4 in treatment sequence B and D.
Drug: Semaglutide C
Participants will receive oral semglutide C in treatment sequence A and B; and at semglutide C at 2x dose level in treatment sequence C and D.
Experimental: Sequence C: Semglutide J-Semaglutide J-Semaglutide C
After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide J at dose level 3 once daily for next 4 weeks and thereafter semaglutide C (2x dose) once daily for next 4 weeks.
Drug: Semaglutide J
Participants will receive oral semglutide J at dose level 1 and 3 in treatment sequence A and C; and at dose level 2 and 4 in treatment sequence B and D.
Drug: Semaglutide C
Participants will receive oral semglutide C in treatment sequence A and B; and at semglutide C at 2x dose level in treatment sequence C and D.
Experimental: Sequence D: Semaglutide J-Semaglutide C-Semaglutide J
After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 2 once daily for 4 weeks followed by semaglutide C (2x dose) once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks.
Drug: Semaglutide J
Participants will receive oral semglutide J at dose level 1 and 3 in treatment sequence A and C; and at dose level 2 and 4 in treatment sequence B and D.
Drug: Semaglutide C
Participants will receive oral semglutide C in treatment sequence A and B; and at semglutide C at 2x dose level in treatment sequence C and D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-24h,semaglutide,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state
Time Frame: From 0 to 24 hours after dosing on days 77, 112 and 147
Measured in hours*nanomoles per liter (h*nmol/L).
From 0 to 24 hours after dosing on days 77, 112 and 147

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax,0-24h.semaglutide,SS; maximum observed plasma concentration of semaglutide at steady state
Time Frame: From 0 to 24 hours after dosing on days 77, 112 and 147
Measured in nanomoles per liter (nmol/L).
From 0 to 24 hours after dosing on days 77, 112 and 147
tmax,0-24h,semaglutide,SS; Time to maximum semaglutide plasma concentration at steady state
Time Frame: From 0 to 24 hours after dosing on days 77, 112 and 147
Measured in hours (h).
From 0 to 24 hours after dosing on days 77, 112 and 147

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), 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)

March 16, 2023

Primary Completion (Actual)

February 23, 2024

Study Completion (Estimated)

March 28, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9924-4891
  • U1111-1279-6289 (Other Identifier: World Health Organization (WHO))

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

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.

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