Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Combination With Semaglutide in Subjects Being Overweight or With Obesity
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Number of treatment emergent adverse events (TEAEs)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
NNC0174-0833+Semaglutide
Participants will receive increasing doses of NNC0174-0833 along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.
Intervention: NNC0174-0833 (Drug)
NNC0174-0833+Semaglutide
Participants will receive increasing doses of NNC0174-0833 along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.
Intervention: Semaglutide (Drug)
Placebo (NNC0174-0833)+Semaglutide
Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks
Intervention: Semaglutide (Drug)
Placebo (NNC0174-0833)+Semaglutide
Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks
Intervention: Placebo (NNC0174-0833) (Drug)
Outcomes
Primary Outcomes
Number of treatment emergent adverse events (TEAEs)
Time Frame: From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)
Count of events
Secondary Outcomes
- AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state(From last dose (Day 134) until end of treatment (Day 141))
- Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state(From last dose (Day 134) until end of treatment (Day 141))
- AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state(From last dose (Day 134) until end of treatment (Day 141))
- Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state(From last dose (Day 134) until end of treatment (Day 141))