A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05232708
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.5
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers (Diabetes Mellitus, Type 2)	Drug: Semaglutide B, 1.34 mg/mL; Drug: Semaglutide D, 1.0 mg/mL; Drug: Semaglutide D, 1.0 mg/mL; Drug: Semaglutide B, 1.34 mg/mL	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector
• Actual Study Start Date: Jan 19, 2022
• Anticipated Primary Completion Date: Sep 19, 2022
• Anticipated Study Completion Date: Oct 6, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL	Drug: Semaglutide B, 1.34 mg/mL; Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.; Drug: Semaglutide D, 1.0 mg/mL; Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.
Experimental: Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL	Drug: Semaglutide D, 1.0 mg/mL; Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.; Drug: Semaglutide B, 1.34 mg/mL; Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

Outcome Measures

Primary Outcome Measures

1. AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg [0-840 hours after a single dose of s.c. semaglutide 0.5 mg]

   Measured in h*nmol/L

2. Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of s.c. semaglutide 0.5 mg administration [0-840 hours after a single dose of s.c. semaglutide 0.5 mg]

   Measured in nmol/L

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female

• Aged 20-55 years (both inclusive) at the time of signing informed consent

• Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive)

Exclusion Criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method

• Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening

• Abuse or intake of alcohol, defined as any of the below:

• Known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (mL) of beer or lager, 100 mL of wine, or 25 mL spirits).

• Positive alcohol test at screening.

• Abuse or intake of drugs, defined as any of the below:

• Known or suspected drug or chemical substance abuse within 1 year before screening

• Positive drug of abuse test at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Harrow		United Kingdom	HA1 3UJ

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: NCT05232708
• Other Study ID Numbers: NN9535-4885; 2021-003216-25; U1111-1266-4076
• First Posted: Feb 10, 2022
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 8, 2022