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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency dept. 2834 · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-05
Primary Completion
2024-09-06
Completion
2024-12-19
FDA Drug
Yes

Countries

  • Czechia
  • Germany
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564104 on ClinicalTrials.gov