A Research Study to Compare Two Different Forms of Once-weekly Semaglutide in Two Different Injection Pens

NCT ID: NCT04238962

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2020-10-20

Brief Summary

The study will look at how 2 different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide - which version is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1 night and the other visit for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Participants cannot take part in this study if they have any disease or disorder that the study doctor thinks is a health problem. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DV3396

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

Group Type: EXPERIMENTAL

Semaglutide (administered by DV3396 pen-injector)

Intervention Type: DRUG

Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks

PDS290

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

Group Type: ACTIVE_COMPARATOR

Semaglutide (administered by PDS290 pen-injector)

Intervention Type: DRUG

Increasing doses of semaglutide given sc in the stomach for 7 weeks

Interventions

Semaglutide (administered by DV3396 pen-injector)

Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks

Intervention Type: DRUG

Semaglutide (administered by PDS290 pen-injector)

Increasing doses of semaglutide given sc in the stomach for 7 weeks

Intervention Type: DRUG

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 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Body weight between 65.0 and 130.0 kg (both inclusive).
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
• Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
• Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid (the two latter are not allowed within 24 hours before screening), within 14 days prior to the day of screening.
• Abuse or intake of alcohol, defined as any of the below:
• Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than an average intake of 24 g alcohol daily for men and 12 g alcohol daily for women -12 g of alcohol equals about 300 mL of beer or lager, 100 mL of wine, or 25 mL spirits)
• Positive alcohol test at screening
• Abuse or intake of drugs, defined as any of the below:
• Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening
• Positive drug of abuse test at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

U1111-1239-1473

Identifier Type: OTHER

Identifier Source: secondary_id

2019-003477-25

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9535-4601

Identifier Type: -

Identifier Source: org_study_id