Clinical trial NCT03787225: A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity
Official title: Investigation of Pharmacokinetic Properties, Safety and Tolerability of Single Subcutaneous Doses of NNC0174-0833 in Male Japanese and Caucasian Subjects Being Normal Weight, Overweight or With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-12-26
Enrollment: 66
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Secondary outcomes:
measure: Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Novo Nordisk Investigational Site
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure 1452
role: STUDY_DIRECTOR
References: