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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04012255
• Other study ID #: NN9536-4475
• Secondary ID: U1111-1221-96442
• Status: Terminated
• Phase: Phase 1
• Start date: July 15, 2019
• Est. completion date: October 22, 2019

Study information

• Verified date: October 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: October 22, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Semaglutide (administered by DV3396 pen)
Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks
• Semaglutide (administered by PDS290 pen)
Increasing doses of semaglutide given sc in the stomach for 21 weeks

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in body weight	percent	From baseline (Day 1, pre-dose) until the end of treatment (Day 148)