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 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN9838-4692U1111-1271-92592022-000138-41
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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

  Measured in nanomoles \* hours per liter (nmol\*h/L)

  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)

Secondary Outcomes (14)

• Part A: 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)

• Part A: 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)

• Part A: 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)

• Part A: 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)

• Part B: AUC0-∞,SD,cagri: The area under the cagrilintide plasma concentration-time curve from time 0 to infinity after a single dose

  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)

Study Arms (6)

Part A: Participants with normal hepatic function

EXPERIMENTAL

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

Part A: Participants with mild hepatic impairment

EXPERIMENTAL

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

Part A: Participants with moderate hepatic impairment

EXPERIMENTAL

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

Part A: Participants with severe hepatic impairment

EXPERIMENTAL

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

Part B: Sequence 1

EXPERIMENTAL

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).

Drug: Cagrilintide

Part B: Sequence 2

EXPERIMENTAL

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).

Drug: Cagrilintide

Interventions

Cagrilintide 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.

Also known as: NNC0174-0833

Part A: Participants with mild hepatic impairment; Part A: Participants with moderate hepatic impairment; Part A: Participants with normal hepatic function; Part A: Participants with severe hepatic impairment; Part B: Sequence 1; Part B: Sequence 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (4)

Pharmaceutical Research Associates CZ, s.r.o.

Prague, 17000, Czechia

Location

APEX Research

München, 81241, Germany

Location

Summit Clinical Research s.r.o.

Bratislava, 83101, Slovakia

Location

Summit Clinical Research s.r.o.

Malacky, 901 22, Slovakia

Location

MeSH Terms

Interventions

cagrilintide

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: April 5, 2023
• Primary Completion: September 6, 2024
• Study Completion: December 19, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1); SL (2); DE (1)