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公司提出HSG4112作为甘草素（glabridin）的结构类似物，是一种新型抗肥胖化合物。动物研究与I期人体试验结果显示，HSG4112可提升能量消耗、使体重恢复正常，且安全性良好、不易产生耐药性。基于上述结果，该公司计划开展IIa期临床试验，以评估HSG4112在超重及肥胖患者中的安全性与有效性。
方法：本研究为一项为期16周的随机、双盲、安慰剂对照平行组试验，将在韩国五家大型医院开展，旨在评估HSG4112在超重及肥胖患者中的安全性与有效性。符合纳入/排除标准的受试者将获得受试者编号，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干预）。本研究的主要终点为监测从基线至治疗结束时的体质量（千克）变化，同时同步监测安全性与耐受性。
讨论：本试验将评估HSG4112在超重及肥胖成人群体中的有效性与安全性。若能证实该全新作用机制的安全性与有效性，或将显著提升医疗人员及肥胖患者对该产品的认可度。此外，其或可助力需长期治疗的慢性病症的管理。
试验注册：临床试验.gov（ClinicalTrials.gov），标识符为[NCT05197556]。