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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Healthy Volunteers
• Intervention / Treatment: Drug: Semaglutide D Dose 1; Drug: Semaglutide D Dose 2; Drug: Semaglutide D Dose 3; Drug: Semaglutide Dose 6; Drug: Semaglutide Dose 4; Drug: Semaglutide Dose 5

• Study Type: Interventional
• Enrollment (Actual): 546
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3P 3P1
      • Novo Nordisk Investigational Site
• United States
  • California
    • Cypress, California, United States, 90630
      • Novo Nordisk Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• 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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Sequence 1; Crossover arm	Drug: Semaglutide D Dose 1; Tablet given orally; Drug: Semaglutide D Dose 2; Tablet given orally; Drug: Semaglutide D Dose 3; Tablet given orally; Drug: Semaglutide Dose 6; Tablet given orally
Experimental: Group 1 Sequence 2; Crossover arm	Drug: Semaglutide D Dose 3; Tablet given orally; Drug: Semaglutide Dose 6; Tablet given orally; Drug: Semaglutide Dose 4; Tablet given orally; Drug: Semaglutide Dose 5; Tablet given orally
Experimental: Group 2 Sequence 1; Crossover arm	Drug: Semaglutide D Dose 1; Tablet given orally; Drug: Semaglutide D Dose 2; Tablet given orally; Drug: Semaglutide Dose 4; Tablet given orally; Drug: Semaglutide Dose 5; Tablet given orally
Experimental: Group 2 Sequence 2; Crossover arm	Drug: Semaglutide D Dose 1; Tablet given orally; Drug: Semaglutide D Dose 2; Tablet given orally; Drug: Semaglutide Dose 4; Tablet given orally; Drug: Semaglutide Dose 5; Tablet given orally
Experimental: Group 3 Sequence 1; Crossover arm	Drug: Semaglutide D Dose 1; Tablet given orally; Drug: Semaglutide Dose 4; Tablet given orally
Experimental: Group 3 Sequence 2; Crossover arm	Drug: Semaglutide D Dose 1; Tablet given orally; Drug: Semaglutide Dose 4; Tablet given orally

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 (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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NN9924-4799

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