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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04187300
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.3
• Patients Per Site Per Month: 7.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Drug: Semaglutide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 16, 2019
• Actual Primary Completion Date: Sep 23, 2020
• Actual Study Completion Date: Sep 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DV3396 Semaglutide administered with the DV3396 pen-injector (Formulation D)	Drug: Semaglutide; Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks
Experimental: PDS290 Semaglutide administered with the PDS290 pen-injector (Formulation B)	Drug: Semaglutide; Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

Outcome Measures

Primary Outcome Measures

1. AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve [0-168 hours (Day 141-148) after last 2.4 mg dose]

   h*nmol/L

2. Cmax,2.4mg,SS, Maximum observed semaglutide concentration [0-168 hours (Day 141-148) after last 2.4 mg dose]

   nmol/L

Secondary Outcome Measures

1. AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve [0-168 hours (Day 78-85) after last 1 mg dose]

   h*nmol/L

2. Cmax,1mg,SS, Maximum observed semaglutide concentration [0-168 hours (Day 78-85) after last 1 mg dose]

   nmol/L

3. Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose [0-168 hours (Day 141-148) after last 2.4 mg dose]

   h

4. Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose [0-168 hours (Day 78-85) after last 1 mg dose]

   h

5. t½, terminal elimination half-life of semaglutide after last 2.4 mg dose [0-1176 hours (Day 141-190) after last 2.4 mg dose]

   h

6. Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose [0-168 hours (Day 141-148) after last 2.4 mg dose]

   L/h

7. Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose [0-168 hours (Day 78-85) after last 1 mg dose]

   L/h

8. Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose [0-168 hours (Day 141-148) after last 2.4 mg dose]

   L

9. Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose [0-168 hours (Day 78-85) after last 1 mg dose]

   L

10. Change in body weight [From baseline (Day 1, pre-dose) until the end of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Neuss		Germany	41460

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04187300
• Other Study ID Numbers: NN9536-4590; U1111-1236-7697; 2019-002909-21
• First Posted: Dec 5, 2019
• Last Update Posted: Nov 11, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Overweight

Study Results

No Results Posted as of Nov 11, 2021