Elecsys GDF-15 Sample Measurement in Phase 2 in Heart Failure Study
Research type
Research Study
Full title
Measurements of Samples from the GOTHICS collaboration using Elecsys® GDF-15 and Elecsys® GDF-15 RxDx Immunoassay on Heart Failure Indication Trial ID: RD006074 Version 2.0
IRAS ID
321497
Contact name
Ekaterina Bauer
Contact email
Research summary
The Pharma Partner (PP) is developing an anti-Growth Differentiation Factor‑15 (GDF-15) drug, which is a humanized
monoclonal Antibody (Ab). It binds to the GDF-15 protein preventing its interaction with its GDNF family receptor α–like
(GFRAL) receptor. The associated pharma trial investigates the effects of the candidate drug on subjects with Heart
Failure (HF) and elevated concentrations of GDF-15 with a focus on symptoms, function, health-related quality of life
(HRQL), and circulating biomarkers. The primary objective of the PP’s trial is to compare the effect of the candidate
drug versus placebo on HF disease-specific health status in participants with HF.
The PP has entered into a collaboration with Roche Diagnostics for a support of the determination of GDF-15
concentrations in patient samples with Elecsys GDF-15 assay. Roche Diagnostics will provide Elecsys GDF-15 assay
and support the measurements of the provided patient samples.REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0300
Date of REC Opinion
17 Feb 2023
REC opinion
Further Information Favourable Opinion