Skip to main content
OpenTrials
Completed

NCT Number: NCT05227196

A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.

The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.

The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Company Inc., Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 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

  • HbA1c equal to or greater than 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 within 48 hours prior to and during the inpatient periods
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
  • History(a) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant(a).
  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).
  • As declared by the participant or reported in the medical records

Treatment and study plan

Semaglutide D Dose 1

Drug

Tablet given orally

Semaglutide D Dose 2

Drug

Tablet given orally

Semaglutide D Dose 3

Drug

Tablet given orally

Semaglutide Dose 4

Drug

Tablet given orally

Semaglutide Dose 5

Drug

Tablet given orally

Semaglutide Dose 6

Drug

Tablet given orally

Primary outcomes

  1. AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)

    Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

    h∙nmol/L

  2. Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state

    Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

    nmol/L

Secondary outcomes

  1. tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state

    Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

    h

  2. Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state

    Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

    nmol/L

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.