A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations With the DV3396 Pen-injector and 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. 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 stomach with the use of 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 themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total 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: Terminated
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Semaglutide (administered by DV3396 pen); Drug: Semaglutide (administered by PDS290 pen)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55116
    • Novo Nordisk Investigational Site
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 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 Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DV3396; Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)	Drug: Semaglutide (administered by DV3396 pen); Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks
Active Comparator: PDS290; Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product)	Drug: Semaglutide (administered by PDS290 pen); Increasing doses of semaglutide given sc in the stomach for 21 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 following the last administration of semaglutide s.c. 2.4 mg	h*nmol/L	0-168 hours (Day 141-148) after last 2.4 mg dose
Cmax,2.4mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 2.4 mg	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 following the last administration of semaglutide s.c. 1 mg	h*nmol/L	0-168 hours (Day 78-85) after last 1 mg dose
Cmax,1mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 1 mg	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	percent	From baseline (Day 1, pre-dose) until the end of treatment (Day 148)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): October 22, 2019

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: NN9536-4475; U1111-1221-9644 (Other Identifier: World Health Organization (WHO)); 2018-003923-13 (Registry Identifier: 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