Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity



Status:Completed
Conditions:Obesity Weight Loss, Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 55
Updated:10/7/2018
Start Date:March 20, 2017
End Date:August 31, 2017

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Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

This trial is conducted in the United States of America (USA). The aim of this trial is to
assess the safety and tolerability of single doses of NNC9204-1706 administered
subcutaneously in male subjects being overweight or with obesity.


Inclusion Criteria:

- Male subjects aged 18-55 years (both inclusive) at the time of signing informed
consent

- Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening.
Overweight should be due to excess of adipose tissue, as judged by the investigator

Exclusion Criteria:

- Any disorder which in the investigator's opinion might jeopardise subject's safety,
evaluation of results, or compliance with the protocol

- Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic
cardiovascular disease (ASCVD) (as described in the American College of Cardiology and
the American Heart Association Prevention Guideline) risk equal to or above 5%

- Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and
are sexually active with female partner(s) and who are 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 below 1%, such as implants, injectables, oral contraceptives, intrauterine
devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the
period from screening until 3 months following administration of the investigational
medical product
We found this trial at
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Baltimore, Maryland 21229
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Baltimore, MD
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