MDR-001 / MindRank AI - LARVOL DELTA

A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight Participants (clinicaltrials.gov) - P1/2 | N=128 | Completed | Sponsor: MindRank AI Ltd | Recruiting ➔ Completed

Trial completion • Obesity

MDR-001, an AI-Enabled β-arrestin2-Biased Oral GLP-1RA: Efficacy and Safety in Chinese Adults with Overweight or Obesity (ADA 2026) - "MDR-001 significantly reduced BW and improved metabolic measures at W24; with consistent safety profile as other GLP-1 RAs. These promising data support further development of MDR-001 as a convenient oral therapy for obesity."

Clinical • Diabetes • Metabolic Disorders • Obesity • ARRB1

Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: MindRank AI Ltd

New P1 trial • Hepatitis C • Hepatology • Liver Failure

Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: MindRank AI Ltd

New P1 trial

MindRank…announced that the first patient has been dosed in the Phase III clinical trial of MDR-001, its AI-designed oral small-molecule GLP-1 receptor agonist (GLP-1RA) for the treatment of obesity and type 2 diabetes in China (GlobeNewswire) - "The Phase III study, MOBILE, is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the long-term efficacy and safety of MDR-001 in approximately 750 patients across 50 clinical centers in China."

Trial status • Obesity • Type 2 Diabetes Mellitus

A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Participants Who Are Obesity or Overweight (clinicaltrials.gov) - P3 | N=738 | Not yet recruiting | Sponsor: MindRank AI Ltd

New P3 trial • Genetic Disorders • Obesity

MindRank Announces Positive 12-week Once-Daily (QD) Results for AI-Designed Oral GLP-1 Agonist MDR-001 in Adults with Obesity (GlobeNewswire) - "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."

P1 data • Obesity

MindRank Presented Clinical Update on Oral GLP-1RA MDR-001 at LSX World Congress, Highlighting AI-Powered Innovation (GlobeNewswire) - "In its Phase IIb clinical trial, MDR-001 achieved a statistically significant weight reduction of 10.3% at 24 weeks compared to 2.5% with placebo (p<0.00001), with up to 48.1% of participants achieving≥10% weight loss, and placebo-adjusted weight loss ranged from 7.1% to 7.8%. MDR-001 also showed a promising safety and tolerability profile, with no treatment-related serious adverse events (SAEs) reported and a markedly lower discontinuation rate than the 15%–50% typically observed in clinical trials of GLP-1 therapies[1,2]. These findings suggest MDR-001 may offer superior patient adherence and promising clinical utility. The overall hepatic safety profile of the subjects was favorable."

P2b data • Obesity

Phase Ib Clinical Study on the Efficacy and Safety of MDR-001 in Patients Who Are Obesity or Overweight (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: MindRank AI Ltd

New P1 trial • Genetic Disorders • Obesity

10.3% weight loss in 24 weeks! Deruizhi Pharmaceuticals' AI-designed small molecule GLP-1 receptor agonist MDR-001 was successful in Phase IIb clinical trials [Google translation] (Sohu.com) - P2b | N=300 | NCT06606483 | Sponsor: MindRank AI Ltd | "In this multicenter Phase IIb clinical trial led by Professor Ji Linong of Peking University People's Hospital, 317 overweight or obese subjects participated in the study. The results showed that the average weight loss of subjects treated with MDR-001 tablets was 10.3%. In contrast, the placebo group only lost 2.5%. Such results are not only remarkable, but also bring new hope to obese patients...The results of the study showed that the effectiveness of MDR-001 is not only reflected in weight loss, but also in improving metabolic and cardiovascular disease-related indicators. For example, the subjects' waist circumference, blood lipids, blood pressure and other indicators have been significantly improved. Such comprehensive benefits make MDR-001 a very promising weight loss drug....In terms of safety, MDR-001 performed well. No serious adverse events related to drug treatment occurred during the trial."

P2b data • Obesity

A Phase I/IIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese/ Overweight Participants (clinicaltrials.gov) - P1/2 | N=131 | Recruiting | Sponsor: MindRank AI Ltd

New P1/2 trial • Obesity

A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: MindRank AI Ltd

New P2 trial • Genetic Disorders • Obesity