DRUG
NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.
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
Status
Not yet recruiting
Phase
Phase 1
Enrollment
35
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 14, 2026
Study start
May 13, 2026
Primary completion
Dec 1, 2027
Study completion
Dec 1, 2027
Results posted
Not reported
Registry updated
May 14, 2026
Outcomes
What the study measures.
Primary outcomes
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
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)
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
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
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
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)
Number of treatment emergent adverse events (TEAEs)
Time frame · From pre-dose on Day 1 up to Day 28
Measured as number of events
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
2 registered sites.
Slovakia. Showing up to 24 locations stored in the fast local snapshot.
Summit Clinical Research s.r.o.
Bratislava, Slovakia
Summit Clinical Research s.r.o.
Malacky, Slovakia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Amycretin.
NCT IDStudyPhase / statusEnrollmentUpdated
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AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
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A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
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AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
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600
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AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Novo Nordisk · Obesity · Overweight
Phase 3
Recruiting
400
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AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
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Recruiting
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.