A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulation D With the DV3396 Pen-injector and Formulation B With the PDS290 Pen-injector in Subjects With Overweight or Obesity

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are pregnant, breast-feeding or planning to become pregnant during the study period.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DV3396; Semaglutide administered with the DV3396 pen-injector (Formulation D)	Drug: Semaglutide; Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks
EXPERIMENTAL: PDS290; Semaglutide administered with the PDS290 pen-injector (Formulation B)	Drug: Semaglutide; Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve	h*nmol/L	0-168 hours (Day 141-148) after last 2.4 mg dose
Cmax,2.4mg,SS, Maximum observed semaglutide concentration	nmol/L	0-168 hours (Day 141-148) after last 2.4 mg dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve	h*nmol/L	0-168 hours (Day 78-85) after last 1 mg dose
Cmax,1mg,SS, Maximum observed semaglutide concentration	nmol/L	0-168 hours (Day 78-85) after last 1 mg dose
Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose	h	0-168 hours (Day 141-148) after last 2.4 mg dose
Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose	h	0-168 hours (Day 78-85) after last 1 mg dose
t½, terminal elimination half-life of semaglutide after last 2.4 mg dose	h	0-1176 hours (Day 141-190) after last 2.4 mg dose
Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose	L/h	0-168 hours (Day 141-148) after last 2.4 mg dose
Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose	L/h	0-168 hours (Day 78-85) after last 1 mg dose
Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose	L	0-168 hours (Day 141-148) after last 2.4 mg dose
Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose	L	0-168 hours (Day 78-85) after last 1 mg dose
Change in body weight		From baseline (Day 1, pre-dose) until the end of treatment

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2019
• Primary Completion (ACTUAL): September 23, 2020
• Study Completion (ACTUAL): September 23, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (ACTUAL): December 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: NN9536-4590; U1111-1236-7697 (OTHER: World Health Organization (WHO)); 2019-002909-21 (REGISTRY: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No