A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
Completed · Phase 1 · Has a placebo group
Conditions studied: Metabolism and Nutrition Disorders, Overweight or Obesity
In brief
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.
Key facts
- Study ID
- NCT03574584
- Run by
- Novo Nordisk A/S
- People needed
- 37
- Starts
- 2018-06-18
- Expected to finish
- 2019-07-27
- Last updated by the study team
- 2021-07-02
Who can join
Age: 19 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Novo Nordisk Investigational Site — Tempe, Arizona, United States
- Novo Nordisk Investigational Site — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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