A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/17/2019 |
| Start Date: | January 7, 2019 |
| End Date: | April 5, 2019 |
| Contact: | Novo Nordisk |
| Email: | clinicaltrials@novonordisk.com |
| Phone: | (+1) 866-867-7178 |
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
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.
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.
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.
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