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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Cagrilintide
Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.
Other Names:
|
| Experimental: 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. |
Drug: Cagrilintide
Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.
Other Names:
|
| Experimental: 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. |
Drug: Cagrilintide
Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.
Other Names:
|
| Experimental: 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 |
Drug: Cagrilintide
Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- AUC 0-infinity (∞), single dose (SD), cagri: The area under the cagrilintide plasma concentration-time curve fromtime 0 to infinity after a single dose [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)]
Measured in nanomoles * hours per liter (nmol*h/L)
Secondary Outcome Measures
- Cmax,SD,cagri: Maximum observed plasma cagrilintide concentration after a single dose [From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)]
Measured in nanomoles * hours per liter (nmol*h/L).
- Tmax,SD,cagri: Time to maximum observed plasma cagrilintide concentration after a single dose [From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)]
Measured in hours (h).
- T½ SD,cagri:Terminal half-life for cagrilintide after a single dose [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)]
Measured in hours (h).
- CL/F SD,cagri:Apparent clearance of cagrilintide after a single dose [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)]
Measured in liters per hour (L/h).
Eligibility Criteria
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:
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Known or suspected hypersensitivity to study intervention(s) or related products.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | München | Germany | 81241 | |
| 2 | Novo Nordisk Investigational Site | Bratislava | Slovakia | 83101 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9838-4692
- U1111-1271-9259
- 2022-000138-41