Status:
COMPLETED
A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Metabolism and Nutrition Disorder
Obesity
Eligibility:
All Genders
22-55 years
Phase:
PHASE1
Brief Summary
This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks...
Eligibility Criteria
Inclusion
- Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent
- Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)
- Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)
- Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
- Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit
Exclusion
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening
- History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator
Key Trial Info
Start Date :
March 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03479892
Start Date
March 13 2018
End Date
June 4 2019
Last Update
June 26 2019
Active Locations (1)
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1
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78209