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

NCT05232708 | Completed Phase 1

• 3 other identifiers: NN9535-48852021-003216-25U1111-1266-4076
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers (Diabetes Mellitus, Type 2)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL

EXPERIMENTAL

Drug: Semaglutide B, 1.34 mg/mL; Drug: Semaglutide D, 1.0 mg/mL

Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL

EXPERIMENTAL

Drug: Semaglutide D, 1.0 mg/mL; Drug: Semaglutide B, 1.34 mg/mL

Interventions

Semaglutide B, 1.34 mg/mL DRUG

Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL

Semaglutide D, 1.0 mg/mL DRUG

Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.

Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel CPRU, Level 7

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 10, 2022
• Study Start: January 19, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)