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

NCT07587710 | Not Yet Recruiting Phase 1

• 3 other identifiers: NN9490-8156U1111-1320-48752025-521647-20
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• AUC0-∞: The area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose

  Measured as hours\*nanomole per liter (nmol\*h/L)

  From pre-dose on Day 1 up to Day 28

Secondary Outcomes (6)

• Cmax: Maximum observed plasma NNC0487-0111 concentration after a single dose

  From pre-dose on Day 1 until Day 5

• tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single dose

  From pre-dose on Day 1 until Day 5

• t½,: Terminal half-life for NNC0487-0111 after a single dose

  From pre-dose on Day 1 up to Day 28

• Vz/F: Apparent volume of distribution of NNC0487-0111 after a single dose

  From pre-dose on Day 1 up to Day 28

• CL/F: Apparent clearance of NNC0487-0111 after a single dose

  From pre-dose on Day 1 up to Day 28

Study Arms (4)

Severe hepatic impairment

EXPERIMENTAL

Participants will receive single dose of NNC0487-0111 subcutaneously.

Drug: NNC0487-0111

Moderate hepatic impairment

EXPERIMENTAL

Participants will receive single dose of NNC0487-0111 subcutaneously.

Drug: NNC0487-0111

Mild hepatic impairment

EXPERIMENTAL

Participants will receive single dose of NNC0487-0111 subcutaneously.

Drug: NNC0487-0111

Normal hepatic impairment

EXPERIMENTAL

Participants will receive single dose of NNC0487-0111 subcutaneously.

Drug: NNC0487-0111

Interventions

NNC0487-0111 DRUG

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

Mild hepatic impairment; Moderate hepatic impairment; Normal hepatic impairment; Severe hepatic impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (sex at birth).
• Age 18-80 years (both inclusive) at the time of signing informed consent.
• Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.

You may not qualify if:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Summit Clinical Research s.r.o.

Bratislava, 83101, Slovakia

Location

Summit Clinical Research s.r.o.

Malacky, 901 22, Slovakia

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

SL (2)