A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 22 - 55 |
| Updated: | 5/6/2018 |
| Start Date: | March 13, 2018 |
| End Date: | May 4, 2019 |
| Contact: | Novo Nordisk |
| Email: | clinicaltrials@novonordisk.com |
| Phone: | (+1) 866-867-7178 |
A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity
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 at how fast the body removes the study medicine. The participants will
either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the
medicine but does not have active ingredients). Which treatment the participants get is
decided by chance. The participants will get 1 or more injections into the skin of stomach
area once each week for 12 weeks. The study will last for about 4 to 5 months. The
participants will have 18 visits to the clinic.
obesity. The aim of this study is to see if the study medicine is safe for people to take.
The study also looks at how fast the body removes the study medicine. The participants will
either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the
medicine but does not have active ingredients). Which treatment the participants get is
decided by chance. The participants will get 1 or more injections into the skin of stomach
area once each week for 12 weeks. The study will last for about 4 to 5 months. The
participants will have 18 visits to the clinic.
Inclusion Criteria:
- 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 Criteria:
- 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
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