A clinical trial looking at the comparability of two different forms of semaglutide
Research type
Research Study
Full title
A Study to Demonstrate Bioequivalence between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector
IRAS ID
1004174
Contact name
Clinical Transparency (Dept. 1452)
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2021-003216-25
Research summary
This trial is a single-centre, randomised, open-label, two period, two sequence cross-over study in 32 healthy male and female subjects aged 20 to 55 years.
The main purpose of the trial is to compare the amount of semaglutide in blood after subcutaneous (s.c.; under skin) injection using two different solutions of semaglutide, i.e.:
- Semaglutide B: 0.5 mg semaglutide (1.34 mg/mL) applied by a pen-injector (device used for self-injection of medication under the skin) with 0.37 mL injection volume that has already been used in previous trials, and
- Semaglutide D: 0.5 mg semaglutide (1.0 mg/mL) applied by a new ready-to-use pen-injector with integrated prefilled syringe with 0.5 mL injection volume.This is done to find out whether the two solutions are comparable (bioequivalent), meaning a similar amount of trial medicine reaches the blood circulation and is therefore available to the body after administration. The aim is to bring a more patient friendly (easier to use) injection device on the market.
The participants will be divided into 2 groups. In each group participants receive, distributed over two treatment periods, both semaglutide formulations once. Both doses will be separated by 7 to 8 weeks. The administrations in both groups are only distinguished by sequence (either formulation B in the first treatment period and formulation D in the second treatment period or the reverse order).
The trial comprises a screening period of up to 28 days, two in-house stays of about 5 days, and a follow-up period of at least 30 days after each dose.
Semaglutide s.c. has been developed by NovoNordisk A/S for the treatment of type 2 diabetes in several countries including the European Union, United States and Japan under the brand name Ozempic®.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0314
Date of REC Opinion
17 Dec 2021
REC opinion
Further Information Favourable Opinion