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

A Study Investigating the Pharmacokinetic Properties, Safety and Tolerability of NNC0487-0111 in Participants With Various Degrees of Hepatic Impairment and Participants With Normal Hepatic Function

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC0487-0111

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Slovakia
  • Bratislava, Slovakia, 83101
    • Summit Clinical Research s.r.o.
  • Malacky, Slovakia, 901 22
    • Summit Clinical Research s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe hepatic impairment; Participants will receive single dose of NNC0487-0111 subcutaneously.	Drug: NNC0487-0111; NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.
Experimental: Moderate hepatic impairment; Participants will receive single dose of NNC0487-0111 subcutaneously.	Drug: NNC0487-0111; NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.
Experimental: Mild hepatic impairment; Participants will receive single dose of NNC0487-0111 subcutaneously.	Drug: NNC0487-0111; NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.
Experimental: Normal hepatic impairment; Participants will receive single dose of NNC0487-0111 subcutaneously.	Drug: NNC0487-0111; NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax: Maximum observed plasma NNC0487-0111 concentration after a single dose	Measured as nanomoles per liter (nmol/L)	From pre-dose on Day 1 until Day 5
tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single dose	Measured as hour	From pre-dose on Day 1 until Day 5
t½,: Terminal half-life for NNC0487-0111 after a single dose	Measured as hour	From pre-dose on Day 1 up to Day 28
Vz/F: Apparent volume of distribution of NNC0487-0111 after a single dose	Liter	From pre-dose on Day 1 up to Day 28
CL/F: Apparent clearance of NNC0487-0111 after a single dose	Measured as liter per hour (L/h)	From pre-dose on Day 1 up to Day 28
Number of treatment emergent adverse events (TEAEs)	Measured as number of events	From pre-dose on Day 1 up to Day 28

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): May 13, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: NN9490-8156; U1111-1320-4875 (Other Identifier: World Health Organization (WHO)); 2025-521647-20 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No