What does this research mean for the field?

The novel oral GLP-1 receptor agonist MDR-001 significantly reduces body weight and improves metabolic measures over 24 weeks in Chinese adults with overweight or obesity, demonstrating a safety profile consistent with other GLP-1 RAs. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This study evaluates the efficacy and safety of MDR-001, a novel oral GLP-1 receptor agonist for weight loss.

June 7, 2026

2620-P: MDR-001, an AI-Enabled β-arrestin2-Biased Oral GLP-1RA: Efficacy and Safety in Chinese Adults with Overweight or Obesity

Key Points

This study evaluates the efficacy and safety of MDR-001, a novel oral GLP-1 receptor agonist for weight loss.
Randomized, double-blind, phase 2b trial with 317 adults with obesity or overweight.
Participants received one of four BID doses of MDR-001 or placebo for 24 weeks.
Primary endpoint was percentage change in body weight at week 24.
MDR-001 doses achieved LSM weight reductions of -8.0% to -9.6% compared to -2.6% with placebo (p<0.0001).
Greater proportions of participants met weight loss targets of ≥5%, ≥10%, and ≥15% with MDR-001 vs placebo (p<0.01).
Most treatment-emergent adverse events were mild to moderate; only 0.8% discontinued due to adverse events.

Abstract

Introduction and Objective: This study assessed the efficacy and safety of MDR-001, a novel oral GLP-1 RA, in Chinese participants (pts) with overweight or obesity without diabetes. Methods: In this randomized, double-blind, phase 2b study, 317 adults with obesity (BMI ≥28 kg/m2) or overweight (BMI, 24 to 28 kg/m2) were randomized 1:1:1:1:1 to BID doses of MDR-001 at 90, 120, 150, 180 mg or placebo (PBO) for 24 weeks (W). Primary endpoint was the percentage change from baseline in body weight (BW) at W24. Results: At baseline, mean BW was 90.1 kg; BMI was 32.3 kg/m²; 53.5% were female. At W24, least-squares mean (LSM) percentage changes in BW were -8.0%, -9.1%, -9.6%, -9.3% with MDR-001 90, 120, 150, and 180 mg, respectively, vs -2.6% with PBO (all P.0001) (Figure A). The proportion of pts achieving ≥5%, ≥10%, and ≥15% weight loss target, reduction in WC, BMI, FPG, and ALT were significantly greater with all MDR-001 doses vs PBO (all P.01) (Figures B, C, D). Most TEAEs were GIAEs (pooled MDR-001: nausea, 44.5%; vomiting, 37.6%; diarrhea 22.0%; constipation, 4.7%), mostly mild to moderate; occurred mainly in dose escalation phase. Only 0.8% of pts discontinued MDR-001due to TEAEs. No drug-related serious AEs occurred. Conclusion: 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. Disclosure L. Ji: None. L. Gao: Consultant; Current; Innovent Biologics, Inc. L. Zhou: None. H. Cai: None. J. Zeng: None. Y. Zhao: None. L. Zhang: None. C. Meng: None. T. Pan: None. L. Lin: None. S. Liu: None. G. Yang: None. L. Zhang: None. Z. Niu: None.

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2620-P: MDR-001, an AI-Enabled β-arrestin2-Biased Oral GLP-1RA: Efficacy and Safety in Chinese Adults with Overweight or Obesity

Key Points

Abstract

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