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NCT Number: NCT07587710

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Summit Clinical Research s.r.o., Bratislava, Slovakia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0487-0111

Drug

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

Primary outcomes

  1. 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

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

Secondary outcomes

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

    Time frame: From pre-dose on Day 1 until Day 5

    Measured as nanomoles per liter (nmol/L)

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

    Time frame: From pre-dose on Day 1 until Day 5

    Measured as hour

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

    Time frame: From pre-dose on Day 1 up to Day 28

    Measured as hour

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

    Time frame: From pre-dose on Day 1 up to Day 28

    Liter

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

    Time frame: From pre-dose on Day 1 up to Day 28

    Measured as liter per hour (L/h)

  6. Number of treatment emergent adverse events (TEAEs)

    Time frame: From pre-dose on Day 1 up to Day 28

    Measured as number of events

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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