Clinical trial NCT04187300: A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve
timeFrame: 0-168 hours (Day 141-148) after last 2.4 mg dose
measure: Cmax,2.4mg,SS, Maximum observed semaglutide concentration
timeFrame: 0-168 hours (Day 141-148) after last 2.4 mg dose
Secondary outcomes:
measure: AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve
timeFrame: 0-168 hours (Day 78-85) after last 1 mg dose
measure: Cmax,1mg,SS, Maximum observed semaglutide concentration
timeFrame: 0-168 hours (Day 78-85) after last 1 mg dose
measure: Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose
timeFrame: 0-168 hours (Day 141-148) after last 2.4 mg dose
measure: Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose
timeFrame: 0-168 hours (Day 78-85) after last 1 mg dose
measure: t½, terminal elimination half-life of semaglutide after last 2.4 mg dose
timeFrame: 0-1176 hours (Day 141-190) after last 2.4 mg dose
measure: Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose
timeFrame: 0-168 hours (Day 141-148) after last 2.4 mg dose
measure: Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose
timeFrame: 0-168 hours (Day 78-85) after last 1 mg dose
measure: Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose
timeFrame: 0-168 hours (Day 141-148) after last 2.4 mg dose
measure: Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose
timeFrame: 0-168 hours (Day 78-85) after last 1 mg dose
measure: Change in body weight
timeFrame: From baseline (Day 1, pre-dose) until the end of treatment
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: