A Research Study of NNC0165-1875 Alone or Together With Semaglutide 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: | 10/27/2018 |
| Start Date: | October 15, 2018 |
| End Date: | September 11, 2019 |
| Contact: | Novo Nordisk |
| Email: | clinicaltrials@novonordisk.com |
| Phone: | (+1) 866-867-7178 |
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0165-1875 as Monotherapy and in Combination With Semaglutide in Subjects With Overweight or Obesity
The study is looking at possible new medicines for weight control in people with high body
weight. The study looks at how the new medicines work in the body. The study consists of two
parts. If participants take part in Part 1, they will either get a single dose of
NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will
either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of
semaglutide. Which treatment participants get is decided by chance. For Part 1 participants
will get 1 injection. For Part 2 participants will get 2 injections. 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 9 weeks. Participants will have 7 visits to the clinic with the study
doctor.
weight. The study looks at how the new medicines work in the body. The study consists of two
parts. If participants take part in Part 1, they will either get a single dose of
NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will
either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of
semaglutide. Which treatment participants get is decided by chance. For Part 1 participants
will get 1 injection. For Part 2 participants will get 2 injections. 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 9 weeks. Participants will have 7 visits to the clinic with the study
doctor.
Inclusion Criteria:
- Males, aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening.
Overweight should be due to excess adipose tissue, as judged by the investigator
- Body weight greater than or equal to 70 kg
Exclusion Criteria:
- Male of reproductive age who or whose partner(s) is not using adequate contraceptive
methods (adequate contraceptive measures as required by local regulation or practice)
We found this trial at
1
site
Click here to add this to my saved trials
