A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: NNC0174-0833; Drug: Placebo (NNC0174-0833)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03787225

NN9838-4483

U1111-1219-7303 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.

Enrollment: 66 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
• For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
• For Caucasian subjects, self-reported European descent or white Latin-American descent.
• Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Body weight between 60 and 110 kg (both inclusive) at screening

Exclusion criteria

• Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner[s] of childbearing potential), who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 4 patient groups, including a placebo group

NNC0174-0833 (0.3 mg)

Experimental group

Description:

Participants will receive single dose of NNC0174-0833

Treatment:

Drug: NNC0174-0833

NNC0174-0833 (0.9 mg)

Experimental group

Description:

Participants will receive single dose of NNC0174-0833

Treatment:

Drug: NNC0174-0833

NNC0174-0833 (1.8 mg)

Experimental group

Description:

Participants will receive single dose of NNC0174-0833

Treatment:

Drug: NNC0174-0833

Placebo (NNC0174-0833)

Placebo Comparator group

Description:

Participants will receive placebo (NNC0174-0833)

Treatment:

Drug: Placebo (NNC0174-0833)