China-based MindRank’s oral glucagon-like peptide-1 receptor agonist (GLP-1RA) has achieved up to 10.5% weight loss in a Phase IIb trial.
The biotech claims that MDR-001 is the first artificial intelligence (AI)-designed oral GLP-1RA to report positive Phase IIb data.
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In the randomised, placebo-controlled study (NCT06606483), patients receiving MDR-001 achieved mean body weight reductions ranging from 8.2% to 10.3% compared to 2.5% in the placebo group, accounting for placebo-adjusted weight loss ranging from 7.1% to 7.8%.
In MindRank’s study, 70.9% to 85.4% of patients achieved a weight loss of at least 5% while 34.5% to 48.1% achieved a loss of at least 10%. There was also improvement recorded in waist circumference, blood pressure, and lipid profiles.
MDR-001 was well tolerated, with most events being gastrointestinal-related such as nausea and vomiting. There were no serious treatment-related adverse events (AEs) reported. Another manageable safety profile of an oral GLP-1RA marks an important development in the field.
The twice-daily GLP-1RA was investigated in patients from China who were overweight or obese over 24 weeks.
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By GlobalDataPeking University People’s Hospital’s endocrinology and metabolism director and the study’s lead principal investigator Linong Ji said: “MDR-001 has demonstrated compelling efficacy, tolerability, and metabolic benefit in this trial.”
MindRank is now preparing to launch Phase III trials of the candidate while also working on a once-daily option.
This raw weight loss is relatively comparable to Eli Lilly’s oral candidate, orforglipron, which boasted weight reductions ranging between 8.6% to 12.6% compared to 2.0% for placebo at the 26-week primary endpoint time stamp of a Phase II trial (NCT05051579).
Lilly’s candidate also completed a Phase III study in April 2025, with more readouts expected in the coming months.
According to GlobalData analysis, the global GLP-1RA market is experiencing substantial growth and is projected to reach $125bn by 2033.
GlobalData is the parent company of Clinical Trials Arena.
