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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04228354
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 6.9

Study Details

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Primary Purpose: Treatment
• Official Title: A Trial to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.0 mg/mL
• Actual Study Start Date: Jan 29, 2020
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide 0.68 mg/mL Semaglutide administered with the PDS290 pen-injector	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
Experimental: Semaglutide 1.0 mg/mL Semaglutide administered with the PDS290 pen-injector	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

Outcome Measures

Primary Outcome Measures

1. Area under the semaglutide plasma concentration curve from 0 to tz [0-840 hours]

   h*nmol/L

2. Maximum semaglutide plasma concentration [0-840 hours]

   nmol/L

Secondary Outcome Measures

1. Area under the semaglutide plasma concentration curve [0-840 hours]

   h*nmol/L

2. Time to Cmax for semaglutide [0-840 hours]

   h

3. Terminal elimination half-life [0-840 hours]

   h

4. Total apparent clearance of semaglutide [0-840 hours]

   L/h

5. Apparent volume of distribution of semaglutide [0-840 hours]

   L

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

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 & 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: NCT04228354
• Other Study ID Numbers: NN9536-4649; U1111-1241-6257; 2019-004020-37
• First Posted: Jan 14, 2020
• Last Update Posted: Jan 10, 2022
• Last Verified: Jan 1, 2022

• 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: Overweight

Study Results

No Results Posted as of Jan 10, 2022