Recently, "MindRank" announced the Phase IIb clinical data of its AI-designed oral GLP-1 receptor agonist MDR-001.Fierce Biotech, the world's top biopharmaceutical industry mediaReport.
The following is translated from Fierce Biotech:
In June 2025, Hangzhou Derui Zhiyao (MindRank) announced the results of the Chinese Phase IIb study of its AI-designed oral GLP-1R agonist MDR-001.This data indicates that its efficacy is on par with orforglipron, an oral GLP-1R agonist in Phase III clinical trials under Eli Lilly.
Although the weight loss in Eli Lilly's trial was greater, its patients took orforglipron for two more weeks than the participants in MindRank's study, and their baseline weight was 20% higher. Measuring patient weight after 26 weeks, compared to the 24-week mark in the MDR-001 study, might explain the apparent advantage of Eli Lilly’s orforglipron, as the weight loss effects of GLP-1 drugs tend to deepen over time.
Notably, the MDR-001 clinical study specifically enrolled approximately 20% of high-risk participants with a history of liver dysfunction or elevated transaminases.No trend of ALT/AST elevation was observed in any dose group; instead, a decrease in mean transaminase levels from baseline was noted.This is relatively rare in the current oral GLP-1RA track.
In this Phase IIb randomized, double-blind study led by Professor Linnong Ji from Peking University People's Hospital, 317 adults were randomly assigned to receive one of four doses of the oral GLP-1 candidate drug MDR-001 or a placebo.
The candidate drug is taken twice daily, which puts it at a disadvantage compared to competitors like orforglipron that are taken once daily. Nevertheless, data from the Phase IIb clinical trial indicates that MDR-001 remains a competitive drug in the field of oral weight-loss medications.
The average weight loss for patients in the MDR-001 group after 24 weeks was between 8.2% and 10.3%, compared to only 2.5% in the placebo group. This range aligns with data from Eli Lilly, which reported that in the Phase IIb clinical trial of orforglipron, patients experienced weight reductions of 8.6% to 12.6%.
MindRank stated that 70.9% to 85.4% of patients lost at least 5% of their body weight. 34.5% to 48.1% of patients lost at least 10% of their body weight. In Eli Lilly's Phase IIb trial, up to 90% and 71% of patients lost at least 5% and 10% of their body weight, respectively.
MindRank Avoided the Safety Issues That Led to the Failure of Pfizer's Oral GLP-1 Project.This biotech company reported that a significant decrease in overall transaminase levels from baseline was observed even in approximately 20% of subjects with a history of liver dysfunction or elevated transaminases. No drug-related serious adverse events (SAEs) were clinically observed, and only 0.8% of patients discontinued treatment due to adverse events.
It is reported that,MindRank is actively advancing the preparations for Phase III clinical trials and has made positive progress in exploring a once-daily dosing regimen.
Pfizer Abandoned Its Self-Developed Oral GLP-1 in April This Year Due to Potential Drug-Induced Liver Injury Found in Clinical Trials. The International Pharmaceutical Giant Has Discussed Rejoining the International Weight-Loss Competition Through Transactions.
GlobalData predicts that the global GLP-1R agonist market is experiencing significant growth and is expected to exceed $125 billion by 2033.
Report Link:https://www.fiercebiotech.com/biotech/mindrank-reports-10-weight-loss-oral-glp-1-drug-phase-2b