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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy Volunteers

Treatments: Drug: Cagrilintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05564104

NN9838-4692

U1111-1271-9259 (Other Identifier)

2022-000138-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 6 patient groups

Part A: Participants with normal hepatic function

Experimental group

Description:

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

Treatment:

Drug: Cagrilintide

Part A: Participants with mild hepatic impairment

Experimental group

Description:

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.

Treatment:

Drug: Cagrilintide

Part A: Participants with moderate hepatic impairment

Experimental group

Description:

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.

Treatment:

Drug: Cagrilintide

Part A: Participants with severe hepatic impairment

Experimental group

Description:

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.

Treatment:

Drug: Cagrilintide

Part B: Sequence 1

Experimental group

Description:

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).

Treatment:

Drug: Cagrilintide

Part B: Sequence 2

Experimental group

Description:

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).

Treatment:

Drug: Cagrilintide