DOI: Published online: July 24, 2025 1 Institute of Medical Research, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea 2 Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea Correspondence to Seok-Woo Hong, PhD Institute of Medical Research, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea Email: [email protected] Won-Young Lee, MD Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea Email: [email protected] *Jinmi Lee and Eun-Jung Rhee contributed equally to this work as co-first authors

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METAOD005: A Phase IIb (randomized, double-blind, placebo-controlled) study to assess the efficacy (reduction in body weight), safety and tolerability of 12 weeks treatment with daily doses (1, 5, 10, 20 or 30 mg AOD9604) administered orally (capsules) in 300 healthy, clinically obese males, and females of non-child bearing potential, with a BMI 35 kg/m 2