Suspended

Comparing Bioequivalence of Two Semaglutide Formulations in Overweight or Obese Individuals

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

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.

What is being tested

Semaglutide (administered by DV3396 pen)

+ Semaglutide (administered by PDS290 pen)

Drug
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 65 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2019
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Trial to Demonstrate Bioequivalence Between Semaglutide Formulations With the DV3396 Pen-injector and With the PDS290 Pen-injector in Subjects With Overweight or Obesity
NCT04012255
Principal SponsorNovo Nordisk A/S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

29 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

3 inclusion criteria required to participate
Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent

Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)

Body weight between 70.0 and 130.0 kg (both inclusive)

3 exclusion criteria prevent from participating
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method

Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Inability or unwillingness to perform self-injection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)

Group II

Active Comparator
Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product)

Study 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

Suspended

Novo Nordisk Investigational Site

Mainz, GermanyOpen Novo Nordisk Investigational Site in Google Maps
Suspended

Novo Nordisk Investigational Site

Neuss, Germany
Suspended2 Study Centers
Comparing Bioequivalence of Two Semaglutide Formulations in Overweight or Obese Individuals | PatLynk