Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity
Completed · Phase 1 · Has a placebo group
Conditions studied: Metabolism and Nutrition Disorder, Obesity
In brief
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.
Key facts
- Study ID
- NCT03095807
- Run by
- Novo Nordisk A/S
- People needed
- 34
- Starts
- 2017-03-20
- Expected to finish
- 2017-08-31
- Last updated by the study team
- 2018-10-05
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Novo Nordisk Investigational Site — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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