A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
1 other identifier
interventional
546
2 countries
3
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Feb 2022
Longer than P75 for phase_1 healthy-volunteers
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2022
CompletedStudy Start
First participant enrolled
February 4, 2022
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2023
CompletedSeptember 19, 2024
September 1, 2024
1.4 years
February 2, 2022
September 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)
h∙nmol/L
24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state
nmol/L
24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Secondary Outcomes (2)
tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state
24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state
24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Study Arms (6)
Group 1 Sequence 1
EXPERIMENTALCrossover arm
Group 1 Sequence 2
EXPERIMENTALCrossover arm
Group 2 Sequence 1
EXPERIMENTALCrossover arm
Group 2 Sequence 2
EXPERIMENTALCrossover arm
Group 3 Sequence 1
EXPERIMENTALCrossover arm
Group 3 Sequence 2
EXPERIMENTALCrossover arm
Interventions
Tablet given orally
Tablet given orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (3)
Altasciences Clinical LA, Inc.
Cypress, California, 90630, United States
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212, United States
Altasciences Company Inc.
Montreal, Quebec, H3P 3P1, Canada
Related Publications (1)
Nielsen MS, Brondsted L, Kankam M, Morelli G, Nguyen D, Skjoth TV, Patted UR, van Hout M. A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants. Diabetes Ther. 2025 Feb;16(2):269-287. doi: 10.1007/s13300-024-01674-8. Epub 2024 Dec 21.
PMID: 39708086DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (Dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2022
First Posted
February 7, 2022
Study Start
February 4, 2022
Primary Completion
June 28, 2023
Study Completion
August 8, 2023
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com