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A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

Primary Purpose

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 Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
  • Body weight between 70.0 and 130.0 kg (both inclusive)

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
  • Inability or unwillingness to perform self-injection

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DV3396

PDS290

Arm Description

Semaglutide administered with the DV3396 pen-injector (Formulation D)

Semaglutide administered with the PDS290 pen-injector (Formulation B)

Outcomes

Primary Outcome Measures

AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve
h*nmol/L
Cmax,2.4mg,SS, Maximum observed semaglutide concentration
nmol/L

Secondary Outcome Measures

AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve
h*nmol/L
Cmax,1mg,SS, Maximum observed semaglutide concentration
nmol/L
Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose
h
Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose
h
t½, terminal elimination half-life of semaglutide after last 2.4 mg dose
h
Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose
L/h
Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose
L/h
Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose
L
Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose
L
Change in body weight

Full Information

First Posted
December 3, 2019
Last Updated
November 10, 2021
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04187300
Brief Title
A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
Official Title
A Trial to Demonstrate Bioequivalence Between Semaglutide Formulation D With the DV3396 Pen-injector and Formulation B With the PDS290 Pen-injector in Subjects With Overweight or Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
September 23, 2020 (Actual)
Study Completion Date
September 23, 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 forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are 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
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DV3396
Arm Type
Experimental
Arm Description
Semaglutide administered with the DV3396 pen-injector (Formulation D)
Arm Title
PDS290
Arm Type
Experimental
Arm Description
Semaglutide administered with the PDS290 pen-injector (Formulation B)
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks
Primary Outcome Measure Information:
Title
AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve
Description
h*nmol/L
Time Frame
0-168 hours (Day 141-148) after last 2.4 mg dose
Title
Cmax,2.4mg,SS, Maximum observed semaglutide concentration
Description
nmol/L
Time Frame
0-168 hours (Day 141-148) after last 2.4 mg dose
Secondary Outcome Measure Information:
Title
AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve
Description
h*nmol/L
Time Frame
0-168 hours (Day 78-85) after last 1 mg dose
Title
Cmax,1mg,SS, Maximum observed semaglutide concentration
Description
nmol/L
Time Frame
0-168 hours (Day 78-85) after last 1 mg dose
Title
Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose
Description
h
Time Frame
0-168 hours (Day 141-148) after last 2.4 mg dose
Title
Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose
Description
h
Time Frame
0-168 hours (Day 78-85) after last 1 mg dose
Title
t½, terminal elimination half-life of semaglutide after last 2.4 mg dose
Description
h
Time Frame
0-1176 hours (Day 141-190) after last 2.4 mg dose
Title
Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose
Description
L/h
Time Frame
0-168 hours (Day 141-148) after last 2.4 mg dose
Title
Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose
Description
L/h
Time Frame
0-168 hours (Day 78-85) after last 1 mg dose
Title
Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose
Description
L
Time Frame
0-168 hours (Day 141-148) after last 2.4 mg dose
Title
Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose
Description
L
Time Frame
0-168 hours (Day 78-85) after last 1 mg dose
Title
Change in body weight
Time Frame
From baseline (Day 1, pre-dose) until the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive) Body weight between 70.0 and 130.0 kg (both inclusive) Exclusion Criteria: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol Inability or unwillingness to perform self-injection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and 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 Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

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