Introduction and Objective: HDM1002, a novel, orally bioavailable non-peptide full agonist of GLP-1RA, demonstrated promising weight loss in phase 1 trial. This phase 2 study evaluated the efficacy and safety of HDM1002 in Chinese overweight and obese adults without diabetes mellitus.Methods: In this randomized, double-blind, placebo-controlled, multicenter study (NCT06500299), 185 participants (pts) (BMI 28-40 kg/m²) were randomized (1:1:1:1) to receive oral HDM1002 at target doses of 100 mg BID, 200 mg BID and 400 mg QD or placebo (PBO) for 12 weeks. The primary endpoint was percentage change in body weight (BW) from baseline (BL) at week 12.Results: At BL, mean BMI is 31.76 kg/m², mean BW is 90.02 kg; 54.1% of pts were female. At week 12, the least-squares (LS) mean percentage changes in BW from BL were -4.63% with HDM1002 100 mg BID, -6.08% with 200 mg BID, and -6.83% with 400 mg QD vs. -2.88% with PBO. The percentage of participants who achieved weight reduction of 5% or more was 46.8%, 63.0%, and 56.5% with 100 mg BID, 200 mg BID, or 400 mg QD of HDM1002, respectively, and 30.4% with placebo. Additionally, HDM1002 also showed reductions in waist circumference, BMI, SBP, ALT and HbA1c compared with in PBO from BL at week 12. TEAEs occurred in 76.6-93.5% of pts on HDM1002 and 58.7% on placebo. Most common TEAEs with HDM1002 were gastrointestinal events (nausea: 40.4-71.7%, vomiting: 25.5-73.9%, diarrhea: 13.0-23.9%), which were all mild to moderate in severity, and occurred more frequently during titration. No trends in elevated liver enzymes were observed. Of all 185 pts, 180 (97.3%) pts completed treatment, 181 (97.8%) pts completed study.Conclusion: In obese adults without diabetes, HDM1002 showed statistically significant reductions in BW at wk 12 compared with PBO, and exhibited an acceptable safety profile consistent with other GLP-1 RAs.
X. Li: None. L. Zhao: None. Y. Lu: None. Z. Cheng: None. C. Li: None. H. Lang: None. Z. Li: None. J. Tian: None. B. Liu: None. J. Xu: Employee; Current; Huadong Medicine Co., Ltd. Stock/Shareholder; Current; Huadong Medicine Co., Ltd. L. Shen: None. L. Zhong: Employee; Current; HuaDong Pharmaceutical Co., Ltd. H. Lu: Employee; Current; Huadong Medicine Co., Ltd. W. Tu: Employee; Current; Huadong Pharmaceutical Co., Ltd.
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