A double-blind, randomized, placebo-controlled, phase 2 trial examined the efficacy and safety of monlunabant in adults with diabetic kidney disease - PubMed
4 hours ago
- #Clinical trial
- #Monlunabant
- #Diabetic kidney disease
- 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.