Status:
COMPLETED
Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Metabolism and Nutrition Disorder
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study looks at a new study medicine for weight management in people with overweight or obesity. The aim of this study is to find out how safe and tolerable the study medicine is. The study also l...
Eligibility Criteria
Inclusion
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 27.0 and 39.9 kg/m2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
Exclusion
- 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) risk greater than or equal to 5%
- Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) 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), or who intend to donate sperm in the period from screening until 3 months following last administration of the investigational medical product
- Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and who are not using highly effective contraceptive methods (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or who are pregnant, breast-feeding or intend to become pregnant
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2020
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03308721
Start Date
October 16 2017
End Date
January 3 2020
Last Update
December 23 2021
Active Locations (1)
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1
Novo Nordisk Investigational Site
Overland Park, Kansas, United States, 66212