A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 19 - 55 |
| Updated: | 12/20/2018 |
| Start Date: | June 18, 2018 |
| End Date: | August 22, 2019 |
| Contact: | Novo Nordisk |
| Email: | clinicaltrials@novonordisk.com |
| Phone: | (+1) 866-867-7178 |
An Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Multiple Weekly Doses of NNC0165-1562 and Semaglutide in Subjects With Overweight or Obesity
The study is investigating new medicines for weight control in people with high body weight.
The study looks at how the study medicines work in the body. Participants will get
semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is
decided by chance. Participants will get 2 injections per week for 5 months. A study nurse at
the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The
study will last for about 7 months. Participants will have 27 visits to the clinic.
The study looks at how the study medicines work in the body. Participants will get
semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is
decided by chance. Participants will get 2 injections per week for 5 months. A study nurse at
the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The
study will last for about 7 months. Participants will have 27 visits to the clinic.
Inclusion Criteria:
- Male or female, aged 19-55 years (both inclusive) at the time of signing informed
consent.
- Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening.
Obesity should be due to excess adipose tissue, as judged by the investigator.
Exclusion Criteria:
- 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 are not using highly effective contraceptive methods (Pearl
Index less than 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 are
pregnant, breast-feeding or intend to become pregnant.
- Male subjects who are not 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 less than 1%, such
as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or
cervical cap+spermicide), or intend to donate sperm in the period from screening until
3 months following administration of the investigational medical product.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials