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

NCT ID: NCT03787225

Last Updated: 2019-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-06-04

Brief Summary

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.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NNC0174-0833 (0.3 mg)

Participants will receive single dose of NNC0174-0833

Group Type: EXPERIMENTAL

NNC0174-0833

Intervention Type: DRUG

Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.

NNC0174-0833 (0.9 mg)

Participants will receive single dose of NNC0174-0833

Group Type: EXPERIMENTAL

NNC0174-0833

Intervention Type: DRUG

Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.

NNC0174-0833 (1.8 mg)

Participants will receive single dose of NNC0174-0833

Group Type: EXPERIMENTAL

NNC0174-0833

Intervention Type: DRUG

Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.

Placebo (NNC0174-0833)

Participants will receive placebo (NNC0174-0833)

Group Type: PLACEBO_COMPARATOR

Placebo (NNC0174-0833)

Intervention Type: DRUG

Participants will receive NNC0174-0833 matched placebo subcutaneously.

Interventions

NNC0174-0833

Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.

Intervention Type: DRUG

Placebo (NNC0174-0833)

Participants will receive NNC0174-0833 matched placebo subcutaneously.

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: MALE
• 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

Glendale, California, United States

Countries

United States

Other Identifiers

U1111-1219-7303

Identifier Type: OTHER

Identifier Source: secondary_id

NN9838-4483

Identifier Type: -

Identifier Source: org_study_id