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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227196
• Other study ID #: NN9924-4799
• Status: Completed
• Phase: Phase 1
• Start date: February 4, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: September 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: August 8, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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).

1. As declared by the participant or reported in the medical records

Related Conditions & MeSH terms

• Healthy Volunteers
• Type 2 Diabetes

Intervention

Drug:
• Semaglutide D Dose 1
Tablet given orally
• Semaglutide D Dose 2
Tablet given orally
• Semaglutide D Dose 3
Tablet given orally
• Semaglutide Dose 4
Tablet given orally
• Semaglutide Dose 5
Tablet given orally
• Semaglutide Dose 6
Tablet given orally

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Montreal	Quebec
United States	Novo Nordisk Investigational Site	Cypress	California
United States	Novo Nordisk Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state	h	24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
Secondary	Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose 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.