A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
- Conditions
- Metabolism and Nutrition DisordersOverweight or Obesity
- Interventions
- Registration Number
- NCT03574584
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (NNC0165-1562) + Semaglutide NNC0165-1562 Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks. NNC0165-1562 + Semaglutide NNC0165-1562 Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks. NNC0165-1562 + Semaglutide Placebo (NNC0165-1562) Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks. Placebo (NNC0165-1562) + Semaglutide Placebo (NNC0165-1562) Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks. NNC0165-1562 + Semaglutide Semaglutide Participants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks. Placebo (NNC0165-1562) + Semaglutide Semaglutide Participants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
- Primary Outcome Measures
Name Time Method Number of treatment emergent adverse events (TEAEs) Week 0-25 Count of adverse events.
- Secondary Outcome Measures
Name Time Method AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state Week 19 (day 134) to week 20 (day 141) Measured in nmol\*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.
AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state Week 19 (day 134) to week 20 (day 141) Measured in nmol\*h/L. Measured at hours 0, 4, 8, 16, 24, 36, 48, 60 and 168 starting on day 134.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Lincoln, Nebraska, United States