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

Primary Purpose

Healthy Volunteers, Overweight, Obesity

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Semaglutide
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Semaglutide 0.68 mg/mL

Semaglutide 1.0 mg/mL

Arm Description

Semaglutide administered with the PDS290 pen-injector

Semaglutide administered with the PDS290 pen-injector

Outcomes

Primary Outcome Measures

Area under the semaglutide plasma concentration curve from 0 to tz
h*nmol/L
Maximum semaglutide plasma concentration
nmol/L

Secondary Outcome Measures

Area under the semaglutide plasma concentration curve
h*nmol/L
Time to Cmax for semaglutide
h
Terminal elimination half-life
h
Total apparent clearance of semaglutide
L/h
Apparent volume of distribution of semaglutide
L

Full Information

First Posted
January 13, 2020
Last Updated
January 6, 2022
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04228354
Brief Title
A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide
Official Title
A Trial to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.0 mg/mL
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 0.68 mg/mL
Arm Type
Experimental
Arm Description
Semaglutide administered with the PDS290 pen-injector
Arm Title
Semaglutide 1.0 mg/mL
Arm Type
Experimental
Arm Description
Semaglutide administered with the PDS290 pen-injector
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
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
Primary Outcome Measure Information:
Title
Area under the semaglutide plasma concentration curve from 0 to tz
Description
h*nmol/L
Time Frame
0-840 hours
Title
Maximum semaglutide plasma concentration
Description
nmol/L
Time Frame
0-840 hours
Secondary Outcome Measure Information:
Title
Area under the semaglutide plasma concentration curve
Description
h*nmol/L
Time Frame
0-840 hours
Title
Time to Cmax for semaglutide
Description
h
Time Frame
0-840 hours
Title
Terminal elimination half-life
Description
h
Time Frame
0-840 hours
Title
Total apparent clearance of semaglutide
Description
L/h
Time Frame
0-840 hours
Title
Apparent volume of distribution of semaglutide
Description
L
Time Frame
0-840 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor & Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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