A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Behaves in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function

Study Overview
=================
Brief Summary
-----------------
Cagrilintide is under development for weight management. In the development of cagrilintide, it is important to see if liver function influences how the body absorbs, breaks down, and eliminates cagrilintide. This will be tested in this study by comparing the blood levels of cagrilintide in people with reduced liver function to those of people with normal liver function. Cagrilintide is a long-acting study medicine that resembles one of the body's own hormones called amylin that is involved in regulation of food intake and body weight. It is the hope that cagrilintide can help participants with weight management. Both the participant and the study doctor will know what treatment is being provided to the participant. All participants will receive a single dose of 0.9 milligrams (mg)cagrilintide. The study medicine will be given in the form of an injection in a skinfold of the belly (subcutaneous). The study will last up to 10 weeks. If participants are eligible for this study, they will come to the clinic a total of 7 times and stay in the clinic for 7 days (6 nights). Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective contraception and will be counselled on the use of contraception.

Official Title
-----------------
A Study Investigating the Pharmacokinetic Properties of Cagrilintide in Participants With Various Degrees of Hepatic Impairment

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: Cagrilintide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female. Aged 18-80 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 18.5-39.9 kilograms per meter square (kg/m^2) (both inclusive). Specific inclusion criterion only for participants with hepatic impairment: 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with normal hepatic function<br>Participants with normal hepatic function will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1. | Drug: Cagrilintide<br>* Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.<br>* Other names: NNC0174-0833;|
| Experimental: Participants with mild hepatic impairment<br>Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1. | Drug: Cagrilintide<br>* Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.<br>* Other names: NNC0174-0833;|
| Experimental: Participants with moderate hepatic impairment<br>Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1. | Drug: Cagrilintide<br>* Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.<br>* Other names: NNC0174-0833;|
| Experimental: Participants with severe hepatic impairment<br>Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1 | Drug: Cagrilintide<br>* Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.<br>* Other names: NNC0174-0833;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-infinity (∞), single dose (SD), cagri: The area under the cagrilintide plasma concentration-time curve fromtime 0 to infinity after a single dose | Measured in nanomoles * hours per liter (nmol*h/L) | From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 840 hours (post dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,SD,cagri: Maximum observed plasma cagrilintide concentration after a single dose | Measured in nanomoles * hours per liter (nmol*h/L). | From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose) | 
| Tmax,SD,cagri: Time to maximum observed plasma cagrilintide concentration after a single dose | Measured in hours (h). | From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose) | 
| T½ SD,cagri:Terminal half-life for cagrilintide after a single dose | Measured in hours (h). | From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 840 hours (post dose) | 
| CL/F SD,cagri:Apparent clearance of cagrilintide after a single dose | Measured in liters per hour (L/h). | From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 840 hours (post dose) |