A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers Type 2 Diabetes

Treatments: Drug: Placebo (NNC0480-0389); Drug: NNC0480-0389; Drug: Placebo (Semaglutide); Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04878406

U1111-1263-7182 (Other Identifier)

NN9389-4680

Details and patient eligibility

About

This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment participants get is decided by chance. NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities. Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in patients with type 2 diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).The study includes blood sampling.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male aged 20-55 years (both inclusive) at the time of signing the informed consent.
• Both parents of Japanese descent.
• Body mass index between 20.0 kg/m^2 and 24.9 kg/m^2 (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

• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.
• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

24 participants in 6 patient groups, including a placebo group

1.7 mg NNC0480-0389 + 0.5 mg Semaglutide

Experimental group

Description:

Participants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Treatment:

Drug: Semaglutide

Drug: NNC0480-0389

Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide)

Placebo Comparator group

Description:

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Treatment:

Drug: Placebo (Semaglutide)

Drug: Placebo (NNC0480-0389)

8.6 mg NNC0480-0389 + 0.5 mg Semaglutide

Experimental group

Description:

Participants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Treatment:

Drug: Semaglutide

Drug: NNC0480-0389

Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)

Placebo Comparator group

Description:

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Treatment:

Drug: Placebo (Semaglutide)

Drug: Placebo (NNC0480-0389)

30 mg NNC0480-0389 + 0.5 mg Semaglutide

Experimental group

Description:

Participants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Treatment:

Drug: Semaglutide

Drug: NNC0480-0389

Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)

Placebo Comparator group

Description:

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Treatment:

Drug: Placebo (Semaglutide)

Drug: Placebo (NNC0480-0389)