MindRank Pharma Reports Positive Phase I/II Clinical Results for Once-Daily Oral GLP-1RA MDR-001: 8.9% Weight Loss at 12 Weeks

This study is "A 12-week, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of orally administered small molecule MDR-001 tablets in overweight or obese subjects." The study aims to explore a once-daily strategy to achieve the target dose through rapid titration.

This study enrolled a total of 24 adult subjects with obesity or overweight who had poor dietary and exercise control and were accompanied by at least one weight-related comorbidity. The baseline characteristics of the subjects in each group were generally balanced.The average weight was 84.9 kgPatients were randomly assigned in a 2:1 ratio to receive either MDR-001 tablets at a dose of 240 mg once daily or placebo for 12 weeks. The primary endpoint of the study was the percentage change in body weight from baseline at week 12.

MDR-001 Group Shows -8.9% Weight Reduction from Baseline, Placebo Group -0.6% (P<0.001), with Continuous Rapid Decline in Weight Loss Trend and No Plateau Observed. In the MDR-001 group, 93.8% of participants achieved weight loss ≥5%, and 37.5% achieved weight loss ≥10%. Additionally, MDR-001 demonstrated significant improvements in multiple metabolic and cardiovascular disease-related parameters, including waist circumference, blood lipids, blood pressure, and blood glucose levels, offering potential comprehensive clinical benefits for patients.

MDR-001 tablets demonstrated good safety and tolerability. No serious adverse events (SAE), no adverse events of special interest (AESI), no treatment discontinuation, no withdrawal from the trial, and no dose reduction occurred during the study period. The most common adverse events were gastrointestinal reactions (GIAE), including nausea (62.5%), vomiting (43.8%), diarrhea (12.5%), and constipation (6.3%), mostly mild to moderate in severity, primarily occurring during the initial 6-week titration period, with all cases resolving completely thereafter.

Throughout the study period, no AST/ALT elevation, increased heart rate, elevated creatinine, elevated lipase or amylase, hypoglycemia, or QT interval prolongation was observed, and no new safety signals were identified.

This Year6Month, MindRankMDR-001 IIbPeriodBIDSuccessfully reached the clinical endpoint in the dosing regimen study. The study results showed that obese or overweight subjects who received treatment24Weeks later,MDR-001Group weight loss up to10.3%, and demonstrated excellent safety and tolerability.

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