Abstract
<title>Abstract</title> <p> <bold>Background and aims</bold> : Henagliflozin (SHR3824) is a novel sodium–glucose cotransporter-2 (SGLT2) inhibitor approved in China for type 2 diabetes mellitus (T2DM). Its efficacy and safety relative to placebo have not been quantitatively synthesized. We addressed this gap with a systematic review and meta-analysis. <bold>Methods</bold> : We searched PubMed, Embase, Web of Science, Scopus, ClinicalTrials.gov, the Cochrane Library, and the Chinese Clinical Trial Registry through June 2026 for randomized controlled trials comparing henagliflozin with placebo in adults with T2DM. Two reviewers independently screened studies, extracted data, and assessed risk of bias using the Cochrane RoB 2 tool. The primary outcome was change in glycated hemoglobin (HbA1c). Random-effects meta-analysis was performed in Review Manager 5.4, and certainty of evidence was rated with GRADE. <bold>Results</bold> : Three RCTs (n = 1,077; all conducted in Chinese adults) met the inclusion criteria. Henagliflozin reduced HbA1c by 0.8% versus placebo (95% CI: −0.93 to − 0.63; I² = 65%; moderate-certainty evidence). Fasting plasma glucose, postprandial plasma glucose, body weight, and systolic and diastolic blood pressure were also significantly improved. Overall adverse events did not differ between groups (RR 1.06, 95% CI: 0.96 to 1.17; low-certainty evidence). <bold>Conclusions</bold> : In Chinese adults with T2DM, henagliflozin produced glycemic, weight, and blood-pressure benefits consistent with the SGLT2 inhibitor class effect, with a short-term safety profile comparable to placebo. Larger and longer trials in diverse populations are needed to confirm cardio-renal benefits and long-term safety. </p>