Study S000141

A Study Investigating the Pharmacokinetic Properties of Cagrilintide in Participants With Various Degrees of Hepatic Impairment and Assessing the Absolute Bioavailability of Subcutaneous Cagrilintide in Healthy Volunteers

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT05564104
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 32
Start: 2023-04-05
Primary completion: 2024-09-06
Lead sponsor: Novo Nordisk A/S
Conditions: Hepatic Impairment; Healthy Volunteers
Interventions: DRUG:Cagrilintide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1271-9259; EUDRACT_NUMBER:2022-000138-41

Registered primary outcomes

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 [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)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0003002	Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Nielsen MJF, Clinical pharmacokinetics	2026	Other trial	PMID 42228334 DOI	cites ClinicalTrials.gov:NCT05564104; registry reference DERIVED:42228334