ChiCTR2500107600 版本V1.0 版本创建时间2025/08/14 17:20:10 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500107600 

最近更新日期：

Date of Last Refreshed on：

2025-08-14 17:19:51 

注册时间：

Date of Registration：

2025-08-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

去氧胆酸注射液在中国颏下脂肪堆积过多人群中皮下脂肪层注射治疗的随机、盲法、平行、阳性对照的I期临床试验

Public title：

Randomized, blind, parallel, and positive-controlled Phase I clinical trials of subcutaneous fat layer injection treatment in people with excess subcutaneous fat accumulation in Chinese jaws

注册题目简写：

English Acronym：

NBT-QYDS-002

研究课题的正式科学名称：

去氧胆酸注射液在中国颏下脂肪堆积过多人群中皮下脂肪层注射治疗的随机、盲法、平行、阳性对照的I期临床试验

Scientific title：

Randomized, blind, parallel, and positive-controlled Phase I clinical trials of subcutaneous fat layer injection treatment in people with excess subcutaneous fat accumulation in Chinese jaws

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

李玮 

研究负责人：

龙笑 

Applicant：

Li Wei 

Study leader：

Long Xiao  

申请注册联系人电话：

Applicant telephone：

+86 13520464757

研究负责人电话：

Study leader's telephone：

+86 138 1019 3175

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

liwei@imeik.com

研究负责人电子邮件：

Study leader's E-mail：

pumclongxiao@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市朝阳区世茂大厦C座22层

研究负责人通讯地址：

王府井帅府园1号（100730）

Applicant address：

22/F, Block C, Shimao Building, Chaoyang District, Beijing

Study leader's address：

No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京诺博特生物科技有限公司

Applicant's institution：

Beijing Norbert Biotechnology Co., Ltd.

研究负责人所在单位：

中国医学科学院北京协和医院

Affiliation of the Leader：

Peking Union Medical College Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

KS20250654

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中国医学科学院北京协和医院药物临床试验伦理委员会

Name of the ethic committee：

Ethics Committee for Clinical Trials of Drugs at Peking Union Medical College Hospital Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2025-05-12 00:00:00

伦理委员会联系人：

董粤

Contact Name of the ethic committee：

DongYue

伦理委员会联系地址：

王府井帅府园1号（100730）

Contact Address of the ethic committee：

No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 69154183

伦理委员会联系人邮箱：

Contact email of the ethic committee：

dongyue@pumch.cn

研究实施负责（组长）单位：

中国医学科学院北京协和医院

Primary sponsor：

Peking Union Medical College Hospital

研究实施负责（组长）单位地址：

王府井帅府园1号（100730）

Primary sponsor's address：

No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国医学科学院北京协和医院

具体地址：

王府井帅府园1号（100730）

Institution
hospital：

Peking Union Medical College Hospital

Address：

No.1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing

经费或物资来源：

北京诺博特生物科技有限公司

Source(s) of funding：

Beijing Norbert Biotechnology Co., Ltd.

Target disease：

Improved appearance of moderate to severe to heavy bulge or fullness of under the chin of adults

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的： 评价去氧胆酸注射液在中国颏下脂肪堆积过多人群中皮下脂肪层注射治疗的安全性。 次要目的： 评价去氧胆酸注射液在中国颏下脂肪堆积过多人群中皮下脂肪层注射治疗的药代动力学特征及临床疗效。  

Objectives of Study：

Main objectives: Evaluation of the safety of subcutaneous fat layer injection treatment in people with excessive fat accumulation under the Chinese jaw. Secondary Purpose: Evaluation of the pharmacokinetic characteristics and clinical efficacy of subcutaneous fat layer injection treatment in people with excessive fat accumulation under the Chinese jaw.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄：18-65周岁（包括18、65周岁），性别不限； 2.研究者根据CR-SMFRS量表评定为颏下脂肪堆积过多造成中、重度凸起或丰满外观，即颏下脂肪评分为2和3分的受试者； 3.根据研究者判断，拥有足够颏下脂肪以供安全进行皮下脂肪层注射（至少完成20针）； 4.根据研究者的判断，至少筛选前6个月体重稳定，即6个月内体重波动不超过±10%； 5.受试者能够完全了解本项临床试验，具有良好的依从性，且对治疗效果有合理的预期； 6.女性受试者自筛选前两周内未发生无保护性行为；男性受试者（或其伴侣）或女性受试者在整个试验期间及试验结束后3个月内无生育计划或捐精捐卵计划，并能够采取有效避孕措施； 7.自愿参加本试验，并签署知情同意书。

Inclusion criteria

1. Age: 18-65 years old (including 18 or 65 years old), regardless of gender; 2. The researchers rated the appearance of excessive fat accumulation under the edible, heavy bulging or fullness according to the CR-SMFRS scale, that is, subjects with a chin fat score of 2 and 3 points; 3. According to the researcher, have enough chin fat for safe subcutaneous fat injection (at least 20 stitches); 4. According to the researcher's judgment, at least 6 months before screening weight stability, that is, weight fluctuations of not more than ±10% within 6 months; 5. Subjects can fully understand this clinical trial, have good compliance, and have reasonable expectations for treatment effect; 6. Female subjects did not have unprotected sex within two weeks before screening; male subjects (or their partners) or female subjects did not have a fertility plan or sperm donation plan during the entire trial period and within 3 months after the end of the trial, and were able to take effective contraception; 7. voluntarily participate in this trial and sign the informed consent form.

排除标准：

1.既往对去氧胆酸或试验用药品其他组分有过敏反应，对于表面或局部麻醉药有过敏史（例如：利多卡因、苯佐卡因，普鲁卡因等），或过敏体质； 2.既往接受过任何干预方式来治疗颏下脂肪或既往在颈部或颏下区域接受过任何可能影响本试验评估的治疗： a) 既往接受过颏下部位的外科手术（例如埋线手术等）、抽脂治疗或注射过与试验用药品相类似的溶脂药物（例如磷脂酰胆碱等）； b) 筛选前12个月内，接受过颈部或颏下部位的皮肤填充剂（如玻尿酸、胶原蛋白等）、能量类设备治疗（如超声刀、射频、激光等）、微针治疗等； c) 筛选前6个月内颈部或颏下部位接受过强脉冲光治疗； d) 筛选前6个月内接受过颈部或颏下部位肉毒毒素注射治疗，或无创紧肤治疗。 3.计划在研究期间接受颏下部位美容操作，包括但不限于真皮填充、面部拉皮、光电治疗、水光针、微针、化学脱皮术或祛疤手术等； 4.既往有下巴或颈部区域手术史，或颏下有明显的疤痕、感染、癌性或癌前病变、和/或有未痊愈伤口、颌后缩（由于下颏发育不全或者先天性缺少下前牙以及翼外肌功能不全等而造成的一种下颏后退的错牙合畸形），经研究者评估可能影响评价结果； 5.患有皮炎、痤疮等颏颈部皮肤病或瘢痕体质（既往有瘢痕增生的倾向或者瘢痕疙瘩），经研究者判断可能会影响评价结果； 6.既往接受过溶脂治疗效果不佳或发生严重不良反应的受试者； 7.发现有其他原因（例如甲状腺肿大、淋巴结肿大、颈淋巴结病、马德龙病、静息状态下颈阔肌突出等）造成颏下区域增大影响颏下脂肪状况的评估，经研究者判断不宜参加本试验者； 8.糖化血红蛋白（HbA1c）≥6.5%或空腹血糖≥7.0 mmol/L； 9.肝功能受损者，即丙氨酸氨基转移酶（ALT）或天门冬氨酸氨基转移酶（AST）>2倍正常值上限，或总胆红素（TBIL）>2倍正常值上限； 10.肾功能不全者，即通过KDIGO 2012分类定义的CKD-EPI肌酐方程计算的估测肾小球滤过率（eGFR<30ml/min/1.73m2）； 11.筛选时体重指数BMI≤17 kg/m2或者≥40 kg/m2； 12.有吞咽困难症状或病史； 13.研究者判断的颏下皮肤重度松弛的受试者； 14.筛选前2周内使用过会延长凝血时间的药物（例如，阿司匹林、非甾体抗炎药、氯吡格雷、华法林等），或试验期间需要服用任何抗凝血功能的药物（包括但不限于华法林、肝素）； 15.筛选前4周内在颏下皮肤使用过外用药物（如：糖皮质激素、维A酸软膏），或预期在试验过程中（至最后一次注射完成后12周）需要在颏下部位使用这些药物； 16.根据研究者判断，颏下脂肪溶解后会造成颏下皮肤松弛度（Submental skin laxity grade，SMSLG）为4级或具有其他解剖学特征（例如，颈阔肌下脂肪凸出，颈部或下巴区域皮肤松弛，颈阔肌带凸出），从而造成不可接受的美容效果； 17.不能耐受静脉穿刺，有晕针晕血史，存在临床表现显著异常； 18.既往或目前受试者存在可能对此临床试验产生不利影响的心血管系统、胃肠道系统、呼吸系统、内分泌系统、血液和淋巴系统、免疫系统、代谢系统、骨骼系统、肝脏、肾脏、恶性肿瘤（在过去5年内被诊断为恶性肿瘤）等疾病或中枢神经系统障碍以及精神障碍而不能充分理解和合作的受试者； 19.计划在本试验期间进行任何可能会导致体重发生显著变化（≥10%）的手术或服用任何可能会导致体重发生显著变化（≥10%）的药物（例如，全身性皮质类固醇激素、减肥药、减肥手术）或其他可能影响到颏下脂肪的手术或治疗； 20.生命体征、体格检查、实验室检查（血常规、尿常规、血生化、传染性疾病筛查、凝血功能）、妊娠检查（育龄期女性）、药物滥用筛查、12导联心电图检查，结果显示异常并经研究者判断有临床意义，研究者认为不宜参加本试验者； 21.筛选前3个月内每天饮用过量茶、咖啡和/或富含咖啡因的饮料（8杯以上，1杯=250ml）者； 22.筛选前3个月内每周饮酒量大于14单位（1单位酒精≈360ml啤酒或45ml酒精含量为40%的烈酒或150ml葡萄酒），或PK采血期间不能禁酒； 23.筛选前3个月内每日吸烟量大于5支，或PK采血期间不能停止使用任何烟草类产品； 24.首次给药前48h内摄入过影响CYP450代谢酶的食物，比如杨桃、木瓜、火龙果、葡萄柚或其制品，或PK采血期间不能中断； 25.筛选前3个月内献血（包括血液成分）或大量失血（≥200ml）； 26.筛选前6个月内有药物滥用史或使用过毒品； 27.筛选前存在传染性疾病，如：梅毒、艾滋病、乙肝等（梅毒螺旋体抗体（Ant-TP）、HIV抗原/抗体（HIV Ag/Ab）、乙肝表面抗原（HBsAg）、丙肝抗体（HCV）检查结果一项或以上为阳性者）； 28.妊娠或哺乳期女性，或妊娠试验结果为阳性； 29.筛选前3个月内参加过其他任何的药物临床试验； 30.研究者认为不宜参与本试验的其它情况。

Exclusion criteria：

1. Have an allergic reaction to the previous antioxychoic acid or other components of the test drug, have a history of allergies to the surface or local anesthesia (e.g. lidocaine, benzocaine, Prucaine, etc.), or allergic to the substance; 2. Have previously received any intervention to treat under-the- Dennis Fat or any treatment that may have been evaluated in the neck or lower wards area that may have been administered in the past: a) Surgery at the lower geese site (e.g., buried wire surgery, etc.), liposuction treatment or injection of lipid-soluble drugs similar to those used in the test (e.g. phosphatidylcholine, etc.); b) within 12 months before screening, skin fillers (e., hyaluronic acid, lyco., etc.); 3. Plans to receive cosmetic operations on sub- Dennis sites during the study period, including but not limited to dermal filling, facial peeling, photoelectric therapy, water photonics, microneedles, chemical peeling or scar surgery; 4. Have a previous history of surgery in the jaw or neck area, or a significant scar, infection, cancer or precancerous lesions under the jaw, and/or unhealed wounds, jaw contractions (a type of deteriorating denture due to insufficiency in the development of the edible or congenital lack of lower vertebral dentures and insufficiency of the fins), after evaluation by the investigator may affect the evaluation results; 5. with dermatitis, acne and other phlegm of the neck skin disease or scar physique (previously has a tendency to proliferate or scars), which may affect the evaluation results as determined by the researcher; 6. Subjects who have previously received poor lipolytic treatment or serious adverse reactions; 7. found that there are other causes (such as goiter, lymph node swelling, cervical lymph node disease, Madron disease, resting state of the neck broad muscle, etc.) caused by the increase in the area of the lower denture affect the evaluation of the fat condition under the denture, after the researcher judged that it is not appropriate to participate in this test; 8. glycated hemoglobin (HbA1c) >=6.5% or fasting blood sugar >= 7.0 mmol/L; 9. Those with impaired liver function, i.e. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal values, or the upper limit of the normal value of total bilirubin (TBIL) > 2 times the upper limit of normal values; 10. renal insufficiency, that is, the estimated glomerular filtration rate calculated by the CKD-EPI creatinine equation defined by the KDIGO 2012 classification (eGFR <30 ml/min/1.73m^2); 11. Body mass index BMI <= 17 kg/m^2 or >=40 kg/m^2 at screening; 12. have symptoms or medical history of swallowing; 13. Subjects judged by the researchers with severe loosening of the skin under their chin; 14. Medications that prolong the clotting time (e.g. aspirin, non-steroidal anti-inflammatory drugs, clopidogrel, warfarin, etc.) within 2 weeks prior to screening, or any anticoagulant drugs (including but not limited to warfarin, heparin) that are required during the trial; 15. Use topical medications (e.g. glucocorticoids, vitamin A-acid ointments) on the skin under the jaw within 4 weeks prior to screening, or expect to use these drugs at the lower end of the test (12 weeks after the last injection); 16. According to the researchers, the dissolution of the densate will cause the submental skin laxity grade (SMSLG) of the subcutaneous skin laxity (SMSLG) of the lower chin or other anatomical characteristics (for example, the bulge of fat under the neck, swelling of the neck or chin area, and the protruding of the neck and broadety tract), resulting in an unacceptable cosmetic effect; 17. Can not tolerate venous puncture, has a history of halo halo, there is clinical abnormality; 18. Subjects who have been or are not sufficiently understood and cooperating with diseases such as cardiovascular, gastrointestinal system, respiratory system, endocrine system, blood and lymphatic system, immune system, metabolic system, skeletal system, liver, kidney, malignant tumor (diagnosed as a malignant tumor) or a mental disorder that may adversely affect clinical trials; 19. plan to perform any surgery during this trial that may cause significant changes in weight (>=10%) or take any medication that may cause significant changes in weight (e.g., systemic corticosteroid hormones, weight loss drugs, bariatric surgery) or other surgery or treatment that may affect the fat under the chin; 20. vital signs, physical examination, laboratory examination (blood routine, urine routine, blood biochemistry, infectious disease screening, blood clotting function), pregnancy test (women of childbearing age), drug abuse screening, 12 lead electrocardiogram examination, the results show abnormality and the investigator judged clinical significance, the researcher believes that it is not appropriate to participate in this trial; 21. Those who drank excessive tea, coffee and/or caffeine-rich beverages per day (8 or more, 1 cup = 250 ml) per day for the first 3 months of screening; 22. Drink more than 14 units per week (one unit of alcohol ≈ 360 ml beer or 45ml of spirits or 150 ml of wine) in the 3 months prior to screening, or alcohol during PK blood collection; 23. smoking more than 5 cigarettes per day in the 3 months prior to screening, or no use of tobacco products during PK blood collection; 24. within 48 hours before the first dose of food that affects the CYP450 metabolic enzyme, such as popcorn, papaya, dragon fruit, grapefruit or its products, or can not be interrupted during PK blood collection; 25. Blood donation (including blood components) or large blood loss (>=200 ml) within 3 months before screening; 26. Have a history of substance abuse or use of drugs within 6 months before screening; 27. infectious diseases such as syphilis, AIDS, hepatitis B, etc. (syphilis spirosis antibodies (Ant-TP), HIV antigen/antibody (HIV Ag/Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) test results are positive); 28. a pregnant or lactating woman, or a pregnancy test result is positive; 29. Have participated in any other drug clinical trials within 3 months prior to screening; 30. Other circumstances in which the investigators consider it inappropriate to participate in this trial.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2026-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-08-31 00:00:00 至 To 2026-01-31 00:00:00  

干预措施：

Interventions：

组别：

C组

样本量：

10

Group：

C group

Sample size：

干预措施：

给予受试者试验药去氧胆酸注射液，浓度为 10mg/ml 的去氧胆酸注射液，每个注射点皮下注射0.2m注射液，每两个注射点间隔1.5cm。

干预措施代码：

Intervention：

Administer the experimental drug deoxycholic acid injection to the subjects, with a concentration of 10mg/ml deoxycholic acid injection. Subcutaneous inject 0.2m of the injection at each injection point, with a 1.5cm interval between each two injection points.

Intervention code：

组别：

A组

样本量：

10

Group：

A group

Sample size：

干预措施：

给予受试者试验药去氧胆酸注射液，浓度为 10mg/mL 的去氧胆酸注射液，每溯个注射点皮下注射0.2ml注射液,每两个注射点间隔1.0cm

干预措施代码：

Intervention：

Administer the experimental drug deoxycholic acid injection to the subjects, with a concentration of 10mg/mL deoxycholic acid injection. Subcutaneous inject 0.2ml of the injection at each injection point, with a 1.0cm interval between each two injection points

Intervention code：

组别：

D组

样本量：

10

Group：

D group

Sample size：

干预措施：

给予受试者阳性对照药去氧胆酸注射液（Belkyra）去氧胆酸注射液；

干预措施代码：

Intervention：

Give the subject a positive control drug deoxycholic acid injection (Belkyra) deoxycholic acid injection;

Intervention code：

组别：

B组

样本量：

10

Group：

B group

Sample size：

干预措施：

给予受试者试验药去氧胆酸注射液,浓度为 10mg/m 的去氧胆酸注射液，每个注射点皮下注射 0.1ml注射颢液，每两个注射点间隔1.0cm。

干预措施代码：

Intervention：

Administer the experimental drug deoxycholic acid injection to the subjects, with a concentration of 10mg/m deoxycholic acid injection. Subcutaneous inject 0.1ml of the injection solution at each injection point, with a 1.0cm interval between every two injection points.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

中国医学科学院北京协和医院 

单位级别：

三级甲等 

Institution
hospital：

Peking Union Medical College Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京医院 

单位级别：

三级甲等 

Institution
hospital：

Beijing Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

药代动力学指标

指标类型：

次要指标

Outcome：

Pharmacokinetics indicators

Type：

Secondary indicator

测量时间点：

首次治疗后24h评价

测量方法：

首次治疗结束后24h药代动力学评价参数：Cmax，AUC0-t，AUC0-∞，Tmax，T1/2，MRT0-t，MRT0-∞，CL/F，Vz/F，Kel。

Measure time point of outcome：

24 hours of evaluation after the first treatment

Measure method：

Evaluation parameters of 24h pharmacokinetics after the first treatment: Cmax, AUC0-t, AUC0-∞, Tmax, T1/2, MRT0-t, MRT0-∞, CL/F, Vz/F, Kel.

指标中文名：

末次治疗后12周，卡尺测量证实的颏下脂肪厚度相对基线的变化

指标类型：

次要指标

Outcome：

12 weeks after the last treatment, the change in submental fat thickness confirmed by caliper measurement relative to baseline

Type：

Secondary indicator

测量时间点：

末次治疗后12周

测量方法：

使用脂肪卡尺测量

Measure time point of outcome：

12 weeks after the last treatment

Measure method：

Measure with a fat caliper

指标中文名：

后续治疗期和随访期内评价颏下皮肤松弛度

指标类型：

次要指标

Outcome：

Evaluation of submental skin laxity during subsequent treatment and follow-up periods

Type：

Secondary indicator

测量时间点：

后续治疗期和随访期

测量方法：

通过“颏下皮肤松弛度量表（SMSLG）”评价

Measure time point of outcome：

during the subsequent treatment and follow-up periods

Measure method：

SMSLG

指标中文名：

末次治疗后12周，受试者满意度自评量表（SSRS）评分为4-6分的受试者比例

指标类型：

次要指标

Outcome：

12 weeks after the last treatment, the proportion of subjects with a Self Rating Satisfaction Scale (SSRS) score of 4-6

Type：

Secondary indicator

测量时间点：

末次治疗后12周

测量方法：

受试者满意度自评量表（SSRS）

Measure time point of outcome：

12 weeks after the last treatment

Measure method：

Self Rating Satisfaction Scale (SSRS)

指标中文名：

末次治疗后12周，超声证实的颏下脂肪体积相对基线减少至少10%的受试者比例

指标类型：

次要指标

Outcome：

12 weeks after the last treatment, the proportion of subjects whose submental fat volume confirmed by ultrasound decreased by at least 10% relative to baseline

Type：

Secondary indicator

测量时间点：

末次治疗后12周

测量方法：

使用超声测量

Measure time point of outcome：

12 weeks after the last treatment

Measure method：

Use ultrasonic measurement

指标中文名：

末次治疗后4周及12周，受试者报告的颏下脂肪影响量表（PR-SMFIS）总分及PR-SMFIS量表各维度评分相对基线的变化

指标类型：

次要指标

Outcome：

4 weeks and 12 weeks after the last treatment, the total score of the submental fat impact scale (PR-SMFIS) and the changes in the scores of each dimension of the PR-SMFIS scale reported by the subjec

Type：

Secondary indicator

测量时间点：

末次治疗后4周及12周

测量方法：

受试者报告的颏下脂肪影响量表（PR-SMFIS）

Measure time point of outcome：

4 weeks and 12 weeks after the last treatment

Measure method：

Patient Reported Submental Fat Impact Scale (PR-SMFIS)

指标中文名：

注射治疗当天及注射治疗后第1周±2天评价疼痛视觉模拟评分

指标类型：

主要指标

Outcome：

Evaluate pain visual analog score on the day of injection therapy and within 1 week +/- 2 days after injection therapy

Type：

Primary indicator

测量时间点：

当天给药注射过程中（在注射结束后5min内完成）和注射后30min（在注射结束后30min~35min内完成）及

测量方法：

使用VAS评分表进行测量

Measure time point of outcome：

completed within 5 minutes and 30-35 minutes after injection，1 week ± 2 days after injection therap

Measure method：

Use VAS scoring table for measurement

指标中文名：

后续治疗期和随访期内评价特定不良反应发生情况

指标类型：

次要指标

Outcome：

Evaluate the occurrence of specific adverse reactions during subsequent treatment and follow-up periods

Type：

Secondary indicator

测量时间点：

后续治疗期和随访期

测量方法：

由研究者进行收集

Measure time point of outcome：

during the subsequent treatment and follow-up periods

Measure method：

Collected by investigator

指标中文名：

注射治疗后第1周±2天评价颏下皮肤松弛度

指标类型：

主要指标

Outcome：

Evaluation of submental skin laxity on the first week +/- 2 days after injection therapy

Type：

Primary indicator

测量时间点：

注射治疗后第1周±2天

测量方法：

通过“颏下皮肤松弛度量表（SMSLG）”评价

Measure time point of outcome：

1 week ± 2 days after injection therapy

Measure method：

Evaluate through the "SMSLG"

指标中文名：

注射治疗当天及注射治疗后第1周±2天评价所有不良事件的发生情况（不良事件种类、发生率等）

指标类型：

主要指标

Outcome：

Evaluation of the occurrence of all adverse events (type of adverse events, incidence, etc.) on the day of injection treatment and the first week after injection treatment +/- 2 days

Type：

Primary indicator

测量时间点：

注射治疗当天及注射治疗后第1周±2天

测量方法：

Measure time point of outcome：

On the day of injection therapy and the first week +/- 2 days after injection therapy

Measure method：

指标中文名：

末次治疗后4周及12周，临床医生报告的颏下脂肪评定量表（CR-SMFRS）评分和受试者报告的颏下脂肪评定量表（PR-SMFRS）评分较基线同时改善至少2分的受试者比例

指标类型：

次要指标

Outcome：

At 4 and 12 weeks after the last treatment, the under-daised fat assessment scale (CR-SMFRS) score reported by clinicians and the under-daised fat rating scale (PR-SMFRS) score reported by the partici

Type：

Secondary indicator

测量时间点：

末次治疗后4周及12周

测量方法：

临床医生报告的颏下脂肪评定量表（CR-SMFRS）评分和受试者报告的颏下脂肪评定量表（PR-SMFRS）

Measure time point of outcome：

At 4 and 12 weeks after the last treatment

Measure method：

the under-daised fat assessment scale (CR-SMFRS) score reported by clinicians and the under-daised fat rating scale (PR-SMFRS) score reported by the participants

指标中文名：

末次治疗后4周及12周，临床医生报告的颏下脂肪评定量表（CR-SMFRS）评分和受试者报告的颏下脂肪评定量表（PR-SMFRS）评分较基线同时改善至少1分的受试者比例

指标类型：

次要指标

Outcome：

4 and 12 weeks after the last treatment, clinicians reported a lower-hijab fat assessment scale (CR-SMFRS) score and a participant-reported under-the-daised fat assessment scale (PR-SMFRS) score compa

Type：

Secondary indicator

测量时间点：

末次治疗后4周及12周

测量方法：

临床医生报告的颏下脂肪评定量表（CR-SMFRS）评分和受试者报告的颏下脂肪评定量表（PR-SMFRS）

Measure time point of outcome：

At 4 and 12 weeks after the last treatment

Measure method：

the under-daised fat assessment scale (CR-SMFRS) score reported by clinicians and the under-daised fat rating scale (PR-SMFRS) score reported by the participants

指标中文名：

后续治疗期和随访期内评价疼痛视觉模拟评分（VAS评分）

指标类型：

次要指标

Outcome：

Visual Analog Scale (VAS) score for pain assessment during subsequent treatment and follow-up periods

Type：

Secondary indicator

测量时间点：

后续治疗期和随访期

测量方法：

评价疼痛视觉模拟评分（VAS评分）

Measure time point of outcome：

during subsequent treatment and follow-up periods

Measure method：

Visual Analog Scale (VAS)

指标中文名：

后续治疗期和随访期内评价所有不良事件的发生情况

指标类型：

次要指标

Outcome：

Evaluate the occurrence of all adverse events during the subsequent treatment and follow-up periods

Type：

Secondary indicator

测量时间点：

后续治疗期和随访期

测量方法：

Measure time point of outcome：

during the subsequent treatment and follow-up periods

Measure method：

指标中文名：

末次治疗后12周，磁共振成像（MRI）测量证实的颏下脂肪体积相对基线减少至少10%的受试者比例

指标类型：

次要指标

Outcome：

12 weeks after the last treatment, the proportion of subjects whose submental fat volume was confirmed to have decreased by at least 10% relative to baseline by magnetic resonance imaging (MRI) measure

Type：

Secondary indicator

测量时间点：

末次治疗后12周

测量方法：

磁共振成像（MRI）

Measure time point of outcome：

12 weeks after the last treatment,

Measure method：

Magnetic Resonance Imaging (MRI)

指标中文名：

末次治疗后12周，受试者整体满意度调查问卷（SGQ）评分有效响应的受试者比例。

指标类型：

次要指标

Outcome：

The proportion of subjects who responded effectively to the Overall Satisfaction Questionnaire (SGQ) 12 weeks after the last treatment.

Type：

Secondary indicator

测量时间点：

末次治疗后12周

测量方法：

受试者整体满意度调查问卷（SGQ）

Measure time point of outcome：

12 weeks after the last treatment

Measure method：

Overall Subject Satisfaction Questionnaire (SGQ)

指标中文名：

安全性

指标类型：

次要指标

Outcome：

safety

Type：

Secondary indicator

测量时间点：

后续治疗期和随访期

测量方法：

实验室检查、生命体征、体格检查、12导联心电图

Measure time point of outcome：

during the subsequent treatment and follow-up periods

Measure method：

Laboratory examination, vital signs, physical examination, 12 lead electrocardiogram

指标中文名：

注射治疗当天及注射治疗后第1周±2天评价特定不良反应发生情况

指标类型：

主要指标

Outcome：

Evaluate the occurrence of specific adverse reactions on the day of injection therapy and on the first week +/- 2 days after injection therapy

Type：

Primary indicator

测量时间点：

注射治疗当天及注射治疗后第1周±2天

测量方法：

Measure time point of outcome：

On the day of injection therapy and the first week +/- 2 days after injection therapy

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

在筛选时，每名受试者将使用筛选号进行识别，以S+三位阿拉伯数字表示，如S001。筛选合格的受试者将获得一个随机号，随机号由字母“R”+三位阿拉伯数字表示，如R001，按照其实际入组先后顺序从小到大获得随机号，纳入试验的受试者将随机接受试验药物或对照药品。受试者的随机号由与本试验无关的独立统计师产生，独立统计师应用SAS（9.4或更高版本）的PLAN过程，采用区组随机法按1：1：1：1比例生成随机号

Randomization Procedure (please state who generates the random number sequence and by what method)：

At the time of screening, each subject will be identified using a screening number, expressed in S+ three Arabic numerals, such as S001. Screening qualified subjects will receive a random number, randomized number represented by the letter "R" + three Arabic numerals, such as R001, in the order of their actual enrollment from small to large to obtain a random number, and the participants included in the trial will receive the trial drug or control drug at random. The randomization of the subjects was generated by an independent statistician unrelated to this trial, and the independent statistician applied the SAS (9.4 or later) PLAN process, using the group randomization method to generate the random number in a 1:1 ratio.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

单盲，对评估者设盲。

Blinding：

Single blind study with blinded-evaluators

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

本项目使用国内公网能查看到的电子采集和管理系统(Electronic Data Capture, EDC)管理临床试验，并共享试验数据，做到试验过程的透明化，并提高临床试验的管理水平和质量。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

This project uses Electronic Data Capture (EDC) that can be viewed on the domestic public network to manage clinical trials, share trial data, achieve transparency in the trial process, and improve the management level and quality of clinical trials.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据记录于病例报告表及edc中

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data are recorded in the CRF and edc

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-08-14 17:19:51