A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Liver Function and Normal Liver Function

Sponsor
Novo Nordisk A/S
Study ID
NCT07587710
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0487-0111 — DRUG
    NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.

Study Details

The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people with normal liver function.

Key Dates

Start date
May 13, 2026
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Severe hepatic impairment
    Participants will receive single dose of NNC0487-0111 subcutaneously.
  • Experimental: Moderate hepatic impairment
    Participants will receive single dose of NNC0487-0111 subcutaneously.
  • Experimental: Mild hepatic impairment
    Participants will receive single dose of NNC0487-0111 subcutaneously.
  • Experimental: Normal hepatic impairment
    Participants will receive single dose of NNC0487-0111 subcutaneously.

Primary Outcome Measure

AUC0-∞: The area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose [ Time Frame: From pre-dose on Day 1 up to Day 28 ]

Central Contacts

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