A TRIAL TO COMPARE THE INJECTION SITE EXPERIENCE OF 0.25 MG SEMAGLUTIDE SC ADMINISTERED BY 2 DIFFERENT PRODUCTS

INTERVENTION: Product Name: Semaglutide C 0.5 mg/mL DV3396 Pharmaceutical Form: Solution for injection INN or Proposed INN: semaglutide CAS Number: 910463‐68‐2 Other descriptive name: SEMAGLUTIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.5‐ Trade Name: Ozempic Pharmaceutical Form: Solution for injection INN or Proposed INN: semaglutide CAS Number: 910463‐68‐2 Other descriptive name: SEMAGLUTIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.34‐ CONDITION: Healthy volunteers (Diabetes Mellitus, Type 2) (Overweight) (Obesity) ; MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 ‐ Metabolism and nutrition disorders ; MedDRA version: 20.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 ‐ Metabolism and nutrition disorders ; MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 ‐ Metabolism and nutrition disorders Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective: The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide subcutaneously (sc), given as the DV3396 product to that of the PDS290 product. Primary end point(s): Intensity of injection site pain Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: 1 min after each injection (Day 1) SECONDARY OUTCOME: Secondary end point(s): Not applicable Timepoint(s) of evaluation of this end point: Not applicable INCLUSION CRITERIA: ‐ Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing informed consent ‐ Body mass index (BMI) equal to or above 25.0 kg/m^2 ‐ Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the Investigator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19