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

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564104
• Other study ID #: NN9838-4692
• Secondary ID: U1111-1271-92592
• Status: Recruiting
• Phase: Phase 1
• Start date: April 5, 2023
• Est. completion date: January 3, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: January 3, 2025
• Est. primary completion date: January 3, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Cagrilintide
Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.

Locations

Country	Name	City	State
Germany	APEX Research	München
Slovakia	Summit Clinical Research s.r.o.	Bratislava
Slovakia	Summit Clinical Research s.r.o.	Malacky

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC 0-infinity (8), 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	Cmax,SD,cagri: Maximum observed plasma cagrilintide concentration after a single dose	Measured in nanomoles per liter (nmol/L).	From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)
Secondary	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)
Secondary	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)
Secondary	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)