MDR-001

Sept. 29, 2025 -- MindRank AI Ltd., a clinical-stage artificial intelligence (AI)-empowered drug discovery company, today announced the positive topline results of its oral small-molecule GLP-1 receptor agonist MDR-001 in adults with overweight or obesity. Using an optimized once-daily (QD) regimen, MDR-001 achieved a body weight reduction of 8.9% over 12 weeks, compared to 0.6% in the placebo group (Pwith a favorable safety and tolerability profile. This clinical study was "A randomized, double-blind, placebo-controlled Phase Ib trial to evaluate the efficacy and safety of small molecule MDR-001 tablets administered orally for 12 weeks in adults with overweight or obesity." The study was designed to optimize titration strategies to improve gastrointestinal tolerability, and maximize weight loss efficacy during long-term treatment. This dose regimen was achieved by employing a rapidly titrating to the target dose utilizing a once-daily (QD) administration. A total of 24 adults with obesity or overweight, all with inadequate response to diet and exercise and at least one weight-related comorbidity, were enrolled. Baseline characteristics were generally well balanced across treatment groups. The mean body weight was 84.9 kg. Subjects were randomized 2:1 to receive MDR-001 240 mg once daily or placebo over 12 weeks. The primary endpoint was the percentage change in body weight from baseline to Week 12. MDR-001 achieved a mean body weight reduction of -8.9% compared with -0.6% in placebo group (P Safety and Tolerability (12-week) MDR-001 demonstrated favorable safety and tolerability. No serious adverse events (SAEs), no adverse events of special interest (AESIs), no treatment discontinuations, study withdrawals, or dose reductions were reported. The most common adverse events were gastrointestinal, including nausea (62.5%), vomiting (43.8%), diarrhea (12.5%), and constipation (6.3%). These were predominantly mild-to-moderate, occurred mainly during the first six weeks of titration, and were predictable and manageable. No clinically meaningful changes were observed in liver enzymes (AST, ALT, etc.), heart rate, creatinine, lipase, amylase, glucose, or QT interval, and no new safety signals emerged. In June 2025, MDR-001 BID dosing regimen achieved primary endpoints in the Phase IIb clinical trial, the results demonstrated that MDR-001 achieved a weight loss of up to 10.3% over 24 weeks with favorable safety and tolerability profiles in participants with overweight or obesity. MindRank is a clinical stage artificial intelligence (AI)-empowered drug discovery company. By leveraging its proprietary AI platforms (PharmKG™, Molecule Dance™ and Molecule Pro™), the company aims to significantly accelerate the drug discovery process and deliver small molecule medicines with differentiations and clinical benefits. Leading asset MDR-001, an AI-designed oral GLP-1RA small molecule, has successfully completed a phase 2b clinical study. The content above comes from the network. if any infringement, please contact us to modify.

杭州，2025年9月29日—专注于使用人工智能驱动新药研发的「德睿智药」宣布，其自主研发的口服小分子GLP-1RA新药MDR-001片，在治疗超重或肥胖受试者的每日一次（QD）给药方案下，12周时减重达8.9%，安慰剂组减重为0.6%，经安慰剂调整后减重为8.3%（P<0.001），且安全性、耐受性优异。 12周每日一次给药方案 该研究为“一项在超重或肥胖受试者中评价口服小分子MDR-001片治疗的有效性和安全性的随机、双盲、安慰剂对照的12周临床研究”。该研究旨在探索每日一次策略，通过快递滴定方式实现目标剂量。 超重或减肥受试者基线指标 本研究累计入组24例饮食和运动控制不佳、且伴有至少一种体重相关合并症的成人肥胖或超重受试者。各组受试者的基线特征总体平衡，平均体重为84.9kg，以2:1比例随机接受MDR-001片每日一次240 mg或安慰剂治疗12周。研究的主要终点为治疗12周时体重相较基线变化的百分比。 有效性 （12周） MDR-001组体重较基线降低-8.9%，安慰剂组下降-0.6%（P<0.001），减重趋势持续快速下降，未观察到平台期。MDR-001组中93.8%的受试者减重≥5%，37.5%受试者减重≥10%。同时，MDR-001在多个代谢和心血管疾病相关参数方面表现出显著改善，包括腰围、血脂、血压以及血糖等指标，有望为患者带来全面的临床获益。 安全性和耐受性 （12周） MDR-001片表现出良好的安全性和耐受性。试验期间无严重不良事件（SAE），无特别关注的不良事件（AESI），无终止治疗，无退出试验及无降低剂量情况。最常见的不良事件为胃肠道反应（GIAE），包括恶心（62.5%）、呕吐（43.8%）、腹泻（12.5%），便秘（6.3%），多为轻中度，主要发生在前6周滴定期内，后均归为痊愈。 整个研究期间，未观察到 AST/ALT 升高、心率增加、肌酐升高、脂肪酶或淀粉酶升高、低血糖或QT间期延长，也未发现新的安全性信号。 此前已完成24周IIb期临床试验 今年6月，德睿智药MDR-001 IIb期BID给药方案研究中成功达到临床终点，研究结果显示，肥胖或超重受试者在接受治疗24周后，MDR-001组减重高达10.3%，且安全性和耐受性表现优异。 END 关于德睿智药 德睿智药是一家临床阶段AI驱动的创新药物研发公司。公司愿景是 通过推动人工智能和新药研发领域多种前沿技术渗透融合，持续输出兼具差异化和高临床价值的候选药物，从而让更多疾病有药可医，让更多生命重获健康。 公司拥有自研国际领先的工业级一站式AI驱动创新药物研发平台，包括基于知识图谱的数据挖掘平台PharmKG™，蛋白质动态模拟、结构预测平台Molecule Dance™和一站式AI药物设计平台Molecule Pro™。 公司AI医药解决方案曾被欧美权威机构Deep Pharma Intelligence评为“2018-2020全球最重要的11个AI药物研发突破性成就”之一。2023年入选福布斯“Forbes Asia 100 to Watch”榜单，中国大陆仅11家初创公司上榜。2024年入选《财富》杂志IMPACT企业榜“中国最具社会影响力创业公司”。 德睿智药自研一站式AI制药平台 相关阅读： 24周，减重10.3%！德睿智药首款AI设计小分子GLP-1受体激动剂MDR-001 IIb期临床取得成功 德睿智药自研WEE1/YES1双重抑制剂获美国FDA临床批件 AI大模型赋能新药研发情报洞察，德睿智药完成对默沙东中国知识图谱项目关键交付 德睿智药完成超两千万美元A+轮融资，加速推进创新药物管线以及AI平台商业化 德睿智药入选2023福布斯亚太区最值得关注企业100强 AI大语言模型助力抗衰老创新疗法研发，德睿智药获Dynamic Resilience基金支持 更多信息请访问网站：www.mindrank.ai 合作：bd@mindrank.ai   pr@mindrank.ai 其他：info@mindrank.ai