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

Novo Nordisk

Status and phase: Terminated; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Semaglutide (administered by DV3396 pen); Drug: Semaglutide (administered by PDS290 pen)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04012255

NN9536-4475

2018-003923-13 (Registry Identifier)

U1111-1221-9644 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

DV3396

Experimental group

Description:

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

Treatment:

Drug: Semaglutide (administered by DV3396 pen)

PDS290

Active Comparator group

Description:

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

Treatment:

Drug: Semaglutide (administered by PDS290 pen)