Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.

Official Title
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A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: semaglutide
* Drug: placebo


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 Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive) HbA1c (glycosylated haemoglobin) below 6.5% Exclusion Criteria: Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice) Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol History of pancreatitis (acute or chronic) Screening calcitonin equal or above 50 ng/L Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: semaglutide OD + placebo semaglutide OW<br> | Drug: semaglutide<br>* Administered subcutaneously (s.c., under the skin)once daily or once weekly.<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)once daily or once weekly.<br>|
| Placebo Comparator: placebo semaglutide OW + placebo semaglutide OD<br> | Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)once daily or once weekly.<br>|
| Experimental: semaglutide OW + placebo semaglutide OD<br> | Drug: semaglutide<br>* Administered subcutaneously (s.c., under the skin)once daily or once weekly.<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin)once daily or once weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the semaglutide concentration-time curves |  | At steady-state from 0 to168 hours after dosing on day 78 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed semaglutide plasma concentration |  | At steady-state derived from the concentration-time curves, within 168 hours from day 78 | 
| Number of treatment emergent adverse events (TEAEs) |  | From baseline (day 1, post-dose) to last follow-up visit (day 120) | 
| Area under the the single dose concentration-time curve |  | From 0 to 300 min after administration of paracetamol (1.5 g) at day 51 | 
| Area under the the single dose concentration-time curve |  | From 0 to 300 min after administration of paracetamol (1.5 g) at day 79 |