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Not yet recruitingPhase 1

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

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

2

Recruiting sites

Enrollment

35

estimated

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

Primary endpoint

AUC0-∞

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07587710
Org study IDNN9490-8156
Secondary ID2025-521647-20European Medical Agency (EMA)
Secondary IDU1111-1320-4875World Health Organization (WHO)

Timeline

Milestones

Study start2026-05-13estimated
Study first posted2026-05-14actual
Last update posted2026-05-14actual
Primary completion2027-12-01estimated
Study completion2027-12-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

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

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

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

Tmax

descriptive

Secondary/protocol endpoint

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

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

Half-life

descriptive

Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

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

descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.