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

A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers (Diabetes Mellitus, Type 2)
• Intervention / Treatment: Drug: Semaglutide B, 1.34 mg/mL; Drug: Semaglutide D, 1.0 mg/mL

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Parexel CPRU, Level 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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

2

Arms and Interventions

Participant Group / 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured in h*nmol/L	0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of s.c. semaglutide 0.5 mg administration	Measured in nmol/L	0-840 hours after a single dose of s.c. semaglutide 0.5 mg

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): January 19, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9535-4885; 2021-003216-25 (EudraCT Number); U1111-1266-4076 (Other Identifier: World Health Organization (WHO))

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: No
• Studies a U.S. FDA-regulated device product: No