DataSheet1_Effect of anti-obesity agent HSG4112 on overweight and obese patients following 12 weeks of oral treatment: a study protocol for a randomised, double-blind, placebo-controlled, parallel-group, phase 2a clinical trial.pdf

Background: Glaceum Inc. has proposed HSG4112, a structural analogue of glabridin, as a novel anti-obesity compound. Animal studies and phase I human trials have shown that HSG4112 improves energy consumption, normalises weight, and is safe and drug-resistant. Based on these results, the company plans to conduct a phase 2a clinical trial to determine the safety and efficacy of HSG4112 in overweight and obese patients. Methods: A 16-week randomised, double-blind, placebo-controlled, parallel-group trial will be conducted at five large hospitals in South Korea to assess the safety and efficacy of HSG4112 in overweight and obese patients. Participants who meet the inclusion/exclusion criteria will be assigned a subject number and randomly assigned to one of the four treatment groups (one group receiving a placebo) in a 1:1:1:1 ratio. The study’s primary outcome will be to monitor the change in body weight (kg) from baseline to the end of treatment while monitoring safety and tolerability. Discussion: This trial will evaluate the efficacy and safety of HSG4112 in overweight and obese adults. Upon proving the safety and effectiveness of the newly developed mechanism, it might significantly improve the perception of the product among medical personnel and obese patients. Furthermore, it may aid in managing chronic conditions that require long-term treatment.Trial registration:ClinicalTrials.gov, identifier [NCT05197556].

背景：Glaceum Inc. 提出将 HSG4112 作为一种新型抗肥胖化合物，其作为槲皮素的结构类似物。动物实验及 I 期临床试验结果表明，HSG4112 能够改善能量消耗，恢复正常体重，且具有安全性及耐药性。基于这些研究结果，该公司计划开展 IIa 期临床试验，以确定 HSG4112 在超重和肥胖患者中的安全性和有效性。方法：一项为期 16 周的随机、双盲、安慰剂对照、平行分组试验将在韩国五家大型医院进行，旨在评估 HSG4112 在超重和肥胖患者中的安全性和有效性。符合纳入/排除标准的参与者将被分配一个编号，并以 1:1:1:1 的比例随机分配至四个治疗组（其中一组接受安慰剂）。研究的主要结果将是监测从基线至治疗结束时的体重变化（千克），同时监测安全性和耐受性。讨论：本试验旨在评估 HSG4112 在超重和肥胖成人中的有效性和安全性。在证实新开发机制的安全性和有效性后，这或许将显著提升医疗人员及肥胖患者对该产品的认知。此外，它可能有助于管理需要长期治疗的慢性疾病。临床试验注册：ClinicalTrials.gov，标识符 [NCT05197556]。