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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers, Overweight, Obesity

Intervention / Treatment
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* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semaglutide 0.68 mg/mL<br>Semaglutide administered with the PDS290 pen-injector | Drug: Semaglutide<br>* 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<br>|
| Experimental: Semaglutide 1.0 mg/mL<br>Semaglutide administered with the PDS290 pen-injector | Drug: Semaglutide<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the semaglutide plasma concentration curve from 0 to tz | h*nmol/L | 0-840 hours | 
| Maximum semaglutide plasma concentration | nmol/L | 0-840 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the semaglutide plasma concentration curve | h*nmol/L | 0-840 hours | 
| Time to Cmax for semaglutide | h | 0-840 hours | 
| Terminal elimination half-life | h | 0-840 hours | 
| Total apparent clearance of semaglutide | L/h | 0-840 hours | 
| Apparent volume of distribution of semaglutide | L | 0-840 hours |