A double-blind, randomized, placebo-controlled, phase 2 trial examined the efficacy and safety of monlunabant in adults with diabetic kidney disease - PubMed

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A phase 2 trial evaluated monlunabant, a cannabinoid receptor 1 inverse agonist, in adults with diabetic kidney disease (DKD).
Participants were randomized to receive monlunabant (10 mg or 25 mg) or placebo daily for 16 weeks.
Primary endpoint: Change in urine albumin-to-creatinine ratio (UACR) from baseline to week 16.
Secondary endpoints included changes in urine protein-to-creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR).
No significant differences in UACR, UPCR, or eGFR were observed between monlunabant and placebo groups.
Most common adverse events were mild to moderate gastrointestinal disorders (nausea, vomiting, diarrhea).
Study did not establish proof of concept for monlunabant in DKD due to lack of significant efficacy versus placebo.
High variability and placebo response affected interpretation of results.

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