A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/10/2018 |
| Start Date: | July 25, 2018 |
| End Date: | January 22, 2020 |
| Contact: | Novo Nordisk |
| Email: | clinicaltrials@novonordisk.com |
| Phone: | (+1) 866-867-7178 |
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Combination With Semaglutide in Subjects Being Overweight or With Obesity
The aim of this study is to find out how NNC0174-0833 taken with semaglutide works in people
who are overweight or obese. Both study medicines have been investigated on their own. The
study also looks at how the study medicines behave in participant's body and how they are
removed from the participant's body. Participants will get 1 of the following 2 treatments -
which treatment any participant gets is decided by chance: Semaglutide (a new medicine) and
NNC0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine
similar to the study medicine but without active ingredients). Participants will get 2
injections per week for 20 weeks. A study nurse at the clinic will inject the medicine with a
needle in a skin fold in the participant's stomach area. The study will last for about 16
months, but duration of participation for any participant will last up to about 7.5 months.
Participants will have 28 clinic visits with the study staff and some will be overnight
visits. Participants will be asked about their health, medical history and habits including
mental health questionnaires.
who are overweight or obese. Both study medicines have been investigated on their own. The
study also looks at how the study medicines behave in participant's body and how they are
removed from the participant's body. Participants will get 1 of the following 2 treatments -
which treatment any participant gets is decided by chance: Semaglutide (a new medicine) and
NNC0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine
similar to the study medicine but without active ingredients). Participants will get 2
injections per week for 20 weeks. A study nurse at the clinic will inject the medicine with a
needle in a skin fold in the participant's stomach area. The study will last for about 16
months, but duration of participation for any participant will last up to about 7.5 months.
Participants will have 28 clinic visits with the study staff and some will be overnight
visits. Participants will be asked about their health, medical history and habits including
mental health questionnaires.
Inclusion Criteria:
- Male or female of non-childbearing potential, aged 18-55 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.
Overweight should be due to excess adipose tissue, as judged by the investigator.
Exclusion Criteria:
- Any disorder at screening which in the investigator's opinion might jeopardise
subject's safety or compliance with the protocol.
- Male subject who is not sexually abstinent or surgically sterilised (vasectomy) and is
sexually active with female partner(s) of childbearing potential and is 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 last
dose of investigational medical product.
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