Status:
COMPLETED
A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Overweight
Eligibility:
MALE
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03787225
Start Date
January 7 2019
End Date
June 4 2019
Last Update
June 24 2019
Active Locations (1)
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1
Novo Nordisk Investigational Site
Glendale, California, United States, 91206