Mindrank Announces Positive 12-Week Once-Daily (QD) Results For AI-Designed Oral GLP-1 Agonist MDR-001 In Adults With Obesity

(MENAFN- GlobeNewsWire - Nasdaq) HANGZHOU, China and LONDON, Sept. 29, 2025 (GLOBE NEWSWIRE) -- 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 (P<0.001), yielding a placebo-adjusted mean weight loss of 8.3%, with a favorable safety and tolerability profile.

Phase Ib (12-week) QD Study Design
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.

Efficacy (12-week)
MDR-001 achieved a mean body weight reduction of -8.9% compared with -0.6% in placebo group (P<0.001). Weight loss continued with no evidence of plateauing. Clinically meaningful weight loss was observed in the MDR-001 group, with 93.7% and 37.5% of participants losing ≥5% and ≥10% of baseline weight, respectively, compared with 0% in the placebo group. Furthermore, MDR-001 demonstrated improvements in multiple metabolic and cardiovascular disease-related parameters, including waist circumference, lipid profile, blood pressure, and glycemic control, indicating broad clinical benefit.

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.

Phase IIb BID Results Recap
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.

About MindRank
MindRank is a clinical stage artificial intelligence (AI)-empowered drug discovery company. By leveraging its proprietary AI platforms (PharmKGTM, Molecule DanceTM and Molecule ProTM), 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.

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