December 10,MindRankA project has been registered on the ClinicalTrials official websiteMDR-001 TargetsObesity or OverweightPhase III clinical trial of the subject. Public information shows that this is the initiation of the drug.First Phase III。Source:ClinicalTrials Official Website
This is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study aimed at evaluating the efficacy and safety of the oral small-molecule drug MDR-001 tablets as an adjunct to lifestyle intervention in overweight or obese participants over 52 weeks. The goal of this clinical trial is to determine whether the oral drug MDR-001 can improve weight management in overweight or obese adult participants.
MDR-001 is a one-stop solution developed by MindRank using its self-developed Molecule Pro™.AI Drug Discovery PlatformInnovative drug pipeline designed with assistance.
June 19,MindRank AnnouncesMDR-001 Tablets in ChinaObesity or OverweightA Multicenter 24-Week Phase IIb Clinical Trial Conducted in SubjectsAchieve clinical endpoints.The research results show that,Oral MDR-001 Tablets in Various Dose GroupsWeight decreased by -8.2% to -10.3% from baseline, with an absolute weight loss of 7.4 to 9.2 kg, compared to 2.4 kg in the placebo group.70.9% to 85.4% of subjects lost ≥5% of their weight, and 34.5% to 48.1% of subjects lost ≥10% of their weight.At the same time, MDR-001 inImprove Multiple Parameters Related to Metabolic and Cardiovascular Diseases...performed well in various aspects, including waist circumference, blood lipids, blood pressure and other indicators, which is expected to bring comprehensive clinical benefits to patients.In terms of safety,MDR-001 tablets demonstrated good safety and tolerability, with no serious adverse events related to drug treatment during the trial.（SAE）MDR-001: The main adverse events in each treatment group were gastrointestinal reactions, including nausea, vomiting, and diarrhea, mostly mild to moderate and concentrated within the first 6 weeks of the titration period, with a median recovery time of approximately 1-5 days.The overall liver safety of the subjects was good. Notably, the dosing group in this study included approximately 20% of subjects with a history of abnormal liver function and elevated transaminases. No trend of increased transaminases was observed in any of the groups, and compared to the placebo group,MDR-001 Treatment Group Showed Significant Reduction in Transaminase Levels from Baseline。
In addition, the cardiac safety of the subjects was good, and no risk of increased heart rate was observed. There were only 2 cases.（0.8%）Due to adverse events occurring during treatment（TEAE）Treatment discontinuation was significantly lower than the 15%-50% discontinuation rates observed in clinical trials of GLP-1 class drugs. No other significant safety concerns were identified during the study period.
Screenshot source: Insight database
Insight Database Compiled a Monthly List of New Drugs Entering Phase III for the First Time Globally in 2025，Scan the QR code below ?, reply with the keywordPhase III of New DrugCan be obtained for free(Updated once at the beginning of each month, currently updated to November)。Cover Source:Enterprise LogoDisclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If needed, please consult and contact正规医疗机构.PR Article Coordination: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
