A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body

NCT ID: NCT05564104

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2024-12-19

Brief Summary

The study is divided into two parts - Part A and Part B. Cagrilintide in combination with semaglutide, 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 (Part A) and also how the medicine is absorbed and used by the body in healthy participants (Part B). In Part A, this will be tested by comparing the blood levels of cagrilintide in participants with reduced liver function to those of participants with normal liver function and in Part B, it will be tested how this medicine is absorbed and used by comparing blood levels between participants who take the study medicine in different ways. 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. In Part A, 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) and in Part B, all participants will receive the same study medicine, taken in two different ways. Participants will get cagrilintide injected into your vein (intravenously) and injected under the skin (subcutaneously). Which treatment participants get first is decided by chance. The study will last up to 10 weeks in Part A and 91 days in Part B. 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) in Part A and in Part B, participants will stay in the clinic twice for a total of 12 days (10 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.

Conditions

Hepatic Impairment; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Participants with normal hepatic function

Participants with normal hepatic function will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1.

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection as well as intravenously in the form of solution for injection.

Part A: Participants with mild hepatic impairment

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.

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection as well as intravenously in the form of solution for injection.

Part A: Participants with moderate hepatic impairment

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.

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection as well as intravenously in the form of solution for injection.

Part A: Participants with severe hepatic impairment

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.

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection as well as intravenously in the form of solution for injection.

Part B: Sequence 1

Healthy participants will receive a single dose of cagrilintide Dose 1 intravenously (i.v) at the first dosing visit (Day 1), followed by a single dose of cagrilintide Dose 2 s.c. at the second dosing visit (Day 53).

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection as well as intravenously in the form of solution for injection.

Part B: Sequence 2

Healthy participants will receive a single dose of cagrilintide Dose 2 s.c. at the first dosing visit (Day 1), followed by a single dose of cagrilintide Dose 1 i.v at the second dosing visit (Day 53).

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection as well as intravenously in the form of solution for injection.

Interventions

Cagrilintide

Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection as well as intravenously in the form of solution for injection.

Intervention Type: DRUG

Other Intervention Names

NNC0174-0833

Eligibility Criteria

Inclusion Criteria

• Male or female.
• Part A: Aged 18-80 years (both inclusive) at the time of signing informed consent.
• Part B: Aged 18-60 years (both inclusive) at the time of signing informed consent.
• Part A: Body mass index (BMI) between 18.5-39.9 kilograms per meter square (kg/m^2) (both inclusive).
• Part B: BMI between 25-30 kg/m2 (both inclusive).
• Specific inclusion criterion only for Part A 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Pharmaceutical Research Associates CZ, s.r.o.

Prague, , Czechia

APEX Research

München, , Germany

Summit Clinical Research s.r.o.

Bratislava, , Slovakia

Summit Clinical Research s.r.o.

Malacky, , Slovakia

Countries

Czechia; Germany; Slovakia

Other Identifiers

U1111-1271-9259

Identifier Type: OTHER

Identifier Source: secondary_id

2022-000138-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9838-4692

Identifier Type: -

Identifier Source: org_study_id