Overview

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

Status:
Completed
Trial end date:
2017-08-31
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
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