Comparing Bioequivalence of Two Semaglutide Formulations in Overweight or Obese Individuals
This study aims to compare the bioequivalence of two semaglutide formulations by evaluating the concentration of semaglutide in the blood over time and the maximum observed concentration, in overweight or obese individuals.
Semaglutide (administered by DV3396 pen)
+ Semaglutide (administered by PDS290 pen)
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: July 15, 2019
Actual date on which the first participant was enrolled.This study focuses on comparing two different forms of a medication called semaglutide in individuals with overweight or obesity. The goal is to understand how these two forms of semaglutide are absorbed and remain in the bloodstream after injection. Neither form is currently approved for treating obesity. Participants will receive one of the two forms, determined by chance. The study is important as it may help develop a more effective treatment approach for overweight or obesity, potentially improving care for those affected by these conditions. Participants will administer the medication as a weekly injection under the skin of the stomach, using a pen-injector. The type of pen-injector varies between the two forms of semaglutide. Participants will be taught how to self-inject, practicing with a placebo (dummy medication) beforehand. The study lasts approximately 27-30 weeks, with 25 visits to the study doctor. Two visits require a 3-day, 2-night stay in the clinic. Participants will receive a total of 21 injections. If the study doctor identifies potential health risks, a participant may need to withdraw. Pregnant women, breastfeeding women, or those planning pregnancy during the study period cannot participate.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.29 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Novo Nordisk Investigational Site
Mainz, GermanyOpen Novo Nordisk Investigational Site in Google MapsNovo Nordisk Investigational Site
Neuss, Germany