What question did this study set out to answer?

This study aims to evaluate the efficacy and safety of HDM1002 in patients with type 2 diabetes inadequately controlled on diet and exercise or metformin.

June 8, 2026

1218-OR: Efficacy and Safety of a Novel Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist (HDM1002) in Type 2 Diabetes Mellitus Patients Inadequately Controlled on Diet and Exercise or Metformin

Key Points

This study aims to evaluate the efficacy and safety of HDM1002 in patients with type 2 diabetes inadequately controlled on diet and exercise or metformin.
Randomized, double-blind phase 2 study
Patients received HDM1002 or placebo for 12 weeks
Primary endpoint was change in HbA1c from baseline at 12 weeks.
All doses of HDM1002 significantly reduced HbA1c compared to placebo (P < 0.05)
HDM1002 400 mg QD achieved a mean HbA1c reduction of -1.29%
The 400 mg group had -2.14 kg change in body weight vs -0.78 kg for placebo.

Abstract

Introduction and Objective: HDM1002 is an oral small molecule GLP-1RA under development for the treatment of T2DM and obesity. This study evaluated the efficacy and safety of HDM1002 in Chinese adult with T2DM inadequately controlled on diet and exercise(D 0.05). 12-week subgroup analysis: HDM1002 200/400 mg QD reduced HbA1c by 1.60/1.90% in D Current; Huadong Medicine Co., Ltd. L. Shen: None. L. Zhong: Employee; Current; HuaDong Pharmaceutical Co., Ltd. J. Xu: Employee; Current; Huadong Medicine Co., Ltd. Stock/Shareholder; Current; Huadong Medicine Co., Ltd.

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