Metabolism and Nutrition Disorders, Overweight or Obesity
Conditions
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.
Interventions
DRUGNNC0165-1562
Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
DRUGSemaglutide
Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
DRUGPlacebo (NNC0165-1562)
Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Intervention model description
Three (3) cohorts are planned. In each cohort subjects will be assigned to trial product. Subjects will be randomised in a 3:1 manner within cohorts to receive either: 1. Semaglutide and NNC0165-1562 once weekly (9 subjects per cohort) 2. Semaglutide and placebo once weekly (3 subjects per cohort)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Week 0-25 | Count of adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed