24 Weeks, 10.3% Weight Loss: MindRank Pharma’s First AI-Designed Oral Small Molecule GLP-1 Receptor Agonist MDR-001 Achieves Success in Phase IIb Clinical Trial
MindRank
AI Drug Developer
Hangzhou, June 19, 2025 — MindRank, a company focused on using AI-driven new drug development, announced that its self-developed oral small-molecule GLP-1RA new drug MDR-001 tablets have reached the clinical endpoint in a multicenter 24-week Phase IIb clinical trial conducted among Chinese obese or overweight subjects led by Professor Linnong Ji from Peking University People's Hospital. The research results show that obese or overweight subjects receiving MDR-001 tablets for 24 weeksThe weight loss in the treatment group reached up to 10.3%,The weight loss in the placebo group was 2.5% (P<0.00001), and the average weight loss range adjusted for placebo was-7.1% to -7.8%, with excellent safety and tolerability.
Phase IIb Study in Overweight or Obese Subjects
This Phase IIb clinical trial is a multicenter, randomized, double-blind, placebo-controlled study that has enrolled a total of 317 adult subjects who are obese or overweight with inadequate control through diet and exercise and have at least one weight-related comorbidity. The baseline characteristics of the subjects in each group were generally comparable.The average weight was 90.1kg, with a BMI of 32.3kg/m².2, accounting for 53.5% of women.Subjects were randomized in equal proportions to receive MDR-001 tablets at doses of 90mg, 120mg, 150mg, or 180mg twice daily or placebo for 24 weeks. The primary endpoint of the study was the percentage change in body weight from baseline at 24 weeks of treatment.
Efficacy Results (24 Weeks)
Weight Decrease from Baseline in All Dose Groups of Oral MDR-001 Tablets-8.2% to -10.3%,Absolute weight loss of 7.4 to 9.2 kg, compared to 2.4 kg in the placebo group (P<0.00001). 70.9% to 85.4% of subjects lost ≥5% of their weight, and 34.5% to 48.1% of subjects lost ≥10%. Meanwhile, MDR-001Demonstrates excellent performance in improving multiple parameters related to metabolic and cardiovascular diseases.Including indicators such as waist circumference, blood lipids, and blood pressure, which are expected to bring comprehensive clinical benefits to patients.
Safety and Tolerability Results (24 Weeks)
In this study, MDR-001 tablets demonstrated good safety and tolerability, with no drug-related serious adverse events (SAE) occurring during the trial period. The main adverse events in each treatment group of MDR-001 were gastrointestinal reactions, including nausea, vomiting, and diarrhea, most of which were mild to moderate and occurred primarily 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, approximately 20% of the subjects in the dosing group had a history of abnormal liver function and elevated transaminases; no trend of increased transaminases was observed in any group.Compared with the placebo group, the transaminase levels in the MDR-001 treatment group were significantly reduced from baseline.Moreover, the cardiac safety profile was favorable,No risk of increased heart rate was observed. Only 2 cases (0.8%) discontinued treatment due to treatment-emergent adverse events (TEAE).Much lower than the 15%-50% discontinuation rate in GLP-1 class drug clinical trials[1,2]No other significant safety signals were identified during the study period.
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MDR-001 Project Leading PI
Peking University People's HospitalDirector of Endocrinology
"Ji Linong"Professor
MDR-001 has completed the proof-of-concept in obese and overweight populations, demonstrating excellent weight loss efficacy and good safety. As obesity is a significant risk factor for various cardiometabolic diseases, there is an urgent clinical need for safe and effective long-term weight management solutions. Oral small-molecule GLP-1 receptor agonists represent an important therapeutic advancement in this field. We look forward to advancing this highly promising innovative drug into Phase III clinical trials, providing a better treatment option for those in need of pharmaceutical weight loss.
MindRank
Founder/CEOZhangming Niu
Co-FounderZhang Long
MDR-001 Demonstrates Excellent Efficacy and Safety in Phase IIb Clinical Trials, Fully Validating the Outstanding Capability of the New Drug R&D Team and the High Efficiency of the Self-developed AI Drug Discovery Platform Molecule Pro™.Meanwhile, the company has also made good progress in the clinical trial exploring the once-daily dosing regimen of MDR-001.Based on these positive clinical results, we are confident in the upcoming Phase III clinical study and hope to bring this innovative oral weight-loss therapy to patients worldwide as soon as possible.
References:
[1] Nauck, M. A., Quast, D. R., Wefers, J., & Meier, J. J. (2021). GLP-1 receptor agonists in the treatment of type 2 diabetes–state-of-the-art. Molecular metabolism, 46, 101102.
[2] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-topline-phase-2b-results-oral-glp-1r
About MindRank
MindRank is a clinical-stage AI-driven innovative drug discovery company. The company's vision is to continuously deliver differentiated and high-clinical-value drug candidates by promoting the integration of various cutting-edge technologies in artificial intelligence and new drug research and development, thereby enabling more diseases to be treatable and allowing more lives to regain health.
The company has a self-developed, internationally leading industrial-grade one-stop AI-driven innovative drug research and development platform, including the knowledge graph-based data mining platform PharmKG™, the protein dynamic simulation and structure prediction platform Molecule Dance™, and the one-stop AI drug design platform Molecule Pro™.
MindRank's AI pharmaceutical solutions were rated as one of the "11 most important AI drug R&D breakthrough achievements globally from 2018 to 2020" by the authoritative European and American institution Deep Pharma Intelligence. In 2023, it was included in Forbes' "Forbes Asia 100 to Watch" list, with only 11 start-up companies from mainland China making the list. In 2024, it was selected for Fortune magazine's IMPACT Enterprise List as one of "China's most socially influential start-up companies."
MindRank's Self-Developed One-Stop AI Pharmaceutical Platform
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