J1I-MC-GZBU
Research type
Research Study
Full title
A Phase 2b, Double-Blind Study to Investigate the Effect of LY3437943 on Renal Function in Participants with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes
IRAS ID
1008419
Contact name
Veronica Acevedo
Contact email
Sponsor organisation
Eli Lilly and Co.
Research summary
Obesity affects a large number of people worldwide and is associated with increased obesity related diseases and death. Obesity is associated with over 200 health complications, including several identified for developing cardiovascular disease and metabolic disease. In 2015, excess body weight accounted for approximately 4 million deaths and 120 million disability-adjusted life years worldwide.
LY3437943 is a novel peptide which shows potent agonist activity at GIP (glucose-dependent insulinotropic polypeptide), GLP-1 (glucagon-like peptide-1), and glucagon receptors. GIP, GLP-1, and glucagon have roles in the regulation of carbohydrate and lipid metabolism, and energy balance. Each hormone carries unique metabolic regulatory actions, providing an opportunity to combine their receptor signalling in a single molecule. In addition, glucagon receptors are present in the kidney and liver, and glucagon receptor binding and activation may have potentially important physiological roles in regulation of renal function and hemodynamic.
Study GZBU is a Phase 2b study that aims to investigate the mechanism(s) of action of
LY3437943 in the kidney, in participants with overweight or obesity and coexisting CKD, with or without T2D. Study GZBU will investigate the effects of 24 weeks of treatment with LY3437943 on renal hemodynamic, including measurement of glomerular filtration rate using Iohexol clearance, as well as blood flow to kidneys, filtration fraction, renal oxygenation, renal injury, renal function, renal and abdominal adipose tissue, and renal diffusion, assessed using non-invasive Magnetic Resonance Imaging techniques.Participants will be randomly assigned to receive either LY3437943 or placebo.
Patient participation is expected to last up to 33 weeks. The patient will actually receive treatment for approximately 24 weeks. Approximately 120 participants will be enrolled in the study globally, including approximately 19 participants from the UK.REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0729
Date of REC Opinion
18 Oct 2023
REC opinion
Further Information Favourable Opinion