Clinical trial NCT03600480: A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
Official title: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Combination With Semaglutide in Subjects Being Overweight or With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)
Secondary outcomes:
measure: AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state
timeFrame: From last dose (Day 134) until end of treatment (Day 141)
measure: Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state
timeFrame: From last dose (Day 134) until end of treatment (Day 141)
measure: AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state
timeFrame: From last dose (Day 134) until end of treatment (Day 141)
measure: Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state
timeFrame: From last dose (Day 134) until end of treatment (Day 141)
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure 1452
role: STUDY_DIRECTOR
References:
citation: Enebo LB, Berthelsen KK, Kankam M, Lund MT, Rubino DM, Satylganova A, Lau DCW. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet. 2021 May 8;397(10286):1736-1748. doi: 10.1016/S0140-6736(21)00845-X. Epub 2021 Apr 22.