Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT05564104Other idNN9838-4692Other idU1111-1271-9259Other id2022-000138-41

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 32 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 3 countries
Czechia, Germany, Slovakia
Start: 5 Apr 2023
Primary completion: 6 Sept 2024
Completion: 19 Dec 2024
First posted: 3 Oct 2022
Last update posted: 12 Dec 2025
Conditions: Hepatic Impairment · Healthy Volunteers

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 1
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
NCT05564104
5 Apr 2023 to 19 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CagrilintideDrug

Arms6

Experimental
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.
Experimental
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.
Experimental
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.
Experimental
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.
Experimental
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).
Experimental
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).

Primary outcomes1

Outcomes the sponsor listed as primary.

Part A: AUC 0-infinity (∞), single dose (SD), cagri: The area under the cagrilintide plasma concentration-time curve fromtime 0 to infinity after a single dose
Time frame · 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)
Registry description
Measured in nanomoles \* hours per liter (nmol\*h/L)

Secondary outcomes(14)

Part A: Cmax,SD,cagri: Maximum observed plasma cagrilintide concentration after a single dose
Time frame · From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)
Registry description
Measured in nanomoles per liter (nmol/L).
Part A: Tmax,SD,cagri: Time to maximum observed plasma cagrilintide concentration after a single dose
Time frame · From 00 hours (pre-dose), 04, 08, 12, 18, 24, 30, 36, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)
Registry description
Measured in hours (h).
Part A: T½ SD,cagri:Terminal half-life for cagrilintide after a single dose
Time frame · 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)
Registry description
Measured in hours (h).
Part A: CL/F SD,cagri:Apparent clearance of cagrilintide after a single dose
Time frame · 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)
Registry description
Measured in liters per hour (L/h).
Part B: AUC0-∞,SD,cagri: The area under the cagrilintide plasma concentration-time curve from time 0 to infinity after a single dose
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)
Registry description
Measured in nmol\*h/L
Part B: AUC0-last,SD,cagri: The area under the cagrilintide plasma concentration-time curve from time 0 to last quantifiable observation
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)
Registry description
Measured in nmol\*h/L
Part B: Cmax,SD,cagri: Maximum observed plasma cagrilintide concentration after a single dose
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)
Registry description
Measured in nmol/L
Part B: tmax,SD,cagri: Time to maximum observed plasma cagrilintide concentration after a single dose
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96 to 120 hours (post dose)
Registry description
Measured in hours (h)
Part B: t½ SD,cagri: Terminal half-life for cagrilintide after a single dose
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)
Registry description
Measured in hours (h).
Part B: CL/F SD,cagri: Apparent clearance of cagrilintide after a single s.c. dose
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)
Registry description
Measured in L/h.
Part B: CL SD,cagri: Apparent clearance of cagrilintide after a single i.v. dose
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)
Registry description
Measured in L/h.
Part B: V z/F,cagri: Volume of distribution of cagrilintide after a single s.c. dose
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)
Registry description
Measured in liters (L).
Part B: V z,cagri: Volume of distribution of cagrilintide after a single i.v. dose
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)
Registry description
Measured in liters (L).
Part B: MRT SD,cagri: Mean residence time of cagrilintide
Time frame · From 00 hours (pre-dose), 05 mins, 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 30 mins, 02, 02 hours 30 mins, 03, 04, 05, 06, 08, 10, 12, 16, 18, 20, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 120, 168, 336, 504, 672 to 912 hours (post dose)
Registry description
Measured in hours (h).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

7 results

Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.

Nielsen et al. 2026Clinical pharmacokineticscited by 1

PMID 42228334PMC13356073DOI 10.1007/s40262-026-01654-0PUB-42228334

Free to read · publisher termsCC BY-NC7 results

Read at source See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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