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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05227196
• Collaborator: (none)
• Enrollment: 404
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 16.1
• Patients Per Site Per Month: 25.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers; Type 2 Diabetes	Drug: Semaglutide D Dose 1; Drug: Semaglutide D Dose 2; Drug: Semaglutide D Dose 3; Drug: Semaglutide Dose 4; Drug: Semaglutide Dose 5; Drug: Semaglutide Dose 6	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 404 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
• Actual Study Start Date: Feb 4, 2022
• Anticipated Primary Completion Date: May 6, 2023
• Anticipated Study Completion Date: Jun 9, 2023

Arms and Interventions

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 4; Tablet given orally; Drug: Semaglutide Dose 5; Tablet given orally; Drug: Semaglutide Dose 6; 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

Outcome Measures

Primary Outcome Measures

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

1. 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.]

   h

2. 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.]

   nmol/L

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05227196
• Other Study ID Numbers: NN9924-4799
• First Posted: Feb 7, 2022
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 22, 2022