Rationale, design and baseline characteristics of the TRANSCEND-CKD trial of retatrutide in patients with chronic kidney disease
Abstract
Background and hypothesis: Retatrutide is an agonist of the glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 and glucagon receptors that reduced weight and hemoglobin A1c (HbA1c) in individuals with obesity and type 2 diabetes (T2D). Retatrutide may also address key chronic kidney disease (CKD)-related pathophysiological pathways. Mechanism-of-action studies are needed to understand its effects on kidney function.
Methods: TRANSCEND-CKD is a double-blind, placebo-controlled, Phase 2b mechanistic study evaluating the efficacy of retatrutide in adults with overweight/obesity and CKD [estimated glomerular filtration rate (eGFR) 25-75 mL/min/1.73 m2], with and without T2D. Participants were randomized 1:1 to once-weekly retatrutide maximum tolerated dose up to 12 mg or matched placebo. The primary objective is to evaluate the effect of retatrutide versus placebo on change in measured glomerular filtration rate (mGFR) by iohexol clearance from baseline to Week 24. Additional objectives include changes in magnetic resonance imaging-assessed kidney hemodynamic and volumetric measurements, including perirenal and renal sinus fat.
Results: Of 367 participants screened, 146 were randomized to study interventions. The mean age was 65.1 years [standard deviation (SD) 10.6], 45.2% were female and 69.9% were White. The mean weight was 101.1 kg (SD 20.6) and body mass index 35.7 kg/m2 (SD 6.1). Participants with T2D (37.7%) had a mean HbA1c of 7.1% (SD 1.1%), while…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 367 participants or records.
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