A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

Obesity Clinical Trial

Official title:

A Trial to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.0 mg/mL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228354
• Other study ID #: NN9536-4649
• Secondary ID: U1111-1241-62572
• Status: Completed
• Phase: Phase 1
• Start date: January 29, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: January 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body mass index between 20.0 and 27.0 kg/m^2 (both inclusive).

Exclusion Criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
• Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

Related Conditions & MeSH terms

• Healthy Volunteers
• Obesity
• Overweight

Intervention

Drug:
• Semaglutide
Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the semaglutide plasma concentration curve from 0 to tz	h*nmol/L	0-840 hours
Primary	Maximum semaglutide plasma concentration	nmol/L	0-840 hours
Secondary	Area under the semaglutide plasma concentration curve	h*nmol/L	0-840 hours
Secondary	Time to Cmax for semaglutide	h	0-840 hours
Secondary	Terminal elimination half-life	h	0-840 hours
Secondary	Total apparent clearance of semaglutide	L/h	0-840 hours
Secondary	Apparent volume of distribution of semaglutide	L	0-840 hours