Ribupatide

1、研究机构：江苏恒瑞医药股份有限公司、福建盛迪医药有限公司、北京拓界生物医药科技有限公司、Kailera Therapeutics 2、别名：HRS-9531、KAI-9531、BJTJ-0001、Ribupatide、利鲁帕肽、瑞波肽 3、靶点：GLP1R、GIPR 4、剂型及给药途径：皮下注射剂; 注射给药；注射剂; 注射给药 5、结构序列 6、交易 交易名称 交易类型 转让方 受让方 交易时研发状态 权益类型 权益地区 权益适应症 交易金额 交易时间 恒瑞医药关于签署授权许可协议暨对外投资的公告 授权/许可 NewCo 江苏恒瑞医药股份有限公司 Kailera Therapeutics 临床III期 开发/商业化权 美国，欧洲，韩国，日本，其他 首付款：100百万美元里程碑付款：5935百万美元特许权使用费：低个位数至低两位数比例的销售提成  2024-05-17 7、专利布局 公开（公告）号 专利主题 发明名称 申请日 法律状态 CN114222755B 化合物 Glp-1和gip受体双重激动剂化合物及其应用 2021-05-28 CN118530333A 化合物 GLP-1和GIP受体双重激动剂化合物及其应用 2021-05-28 实质审查 CN118754965A 化合物 GLP-1和GIP受体双重激动剂化合物及其应用 2021-05-28 实质审查 CN118103391A 制剂 Glp-1受体和gip受体双重激动剂的药物组合物及其用途 2022-11-11 实质审查 CN122374036A 用途 GLP-1类似物治疗代谢疾病的方法及医药用途 2024-12-12 实质审查 WO2026037397A1 用途 GLP-1类似物的医药用途 2025-08-15 8、研究历程 2026年09月08日，由Kailera Therapeutics Inc在美国开展临床一期试验，用于治疗肾功能不全、终末期肾脏病、肥胖症和超重。（NCT07793929） 2026年08月14日，由江苏恒瑞医药股份有限公司、福建盛迪医药有限公司和北京拓界生物医药科技有限公司在中国大陆开展临床二期试验，用于治疗非酒精性脂肪性肝炎。（CTR20262382; NCT07660848） 2026年07月01日，由福建盛迪医药有限公司在中国大陆开展临床三期试验，用于治疗膝关节炎。（CTR20262669; NCT07709910） 2026年07月01日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗体重。（NCT06506175） 2026年06月09日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗膝关节炎。（CXHL2600399; CXHL2600400; CXHL2600398） 2026年05月29日，由福建盛迪医药有限公司在中国大陆开展临床三期试验，用于治疗动脉粥样硬化。（CTR20261494） 2026年03月31日，由福建盛迪医药有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗膝关节炎，为中国化药一类。（CXHL2600399; CXHL2600400; CXHL2600398） 2026年03月19日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗动脉粥样硬化。（CXHL2600039; CXHL2600040; CXHL2600041） 2026年03月04日，由Kailera Therapeutics Inc在美国开展临床二期试验，用于治疗肥胖症。（NCT07458269） 2026年02月12日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗慢性肾功能不全。（CXHL2501355; CXHL2501356） 2026年01月12日，由Kailera Therapeutics Inc在阿根廷、澳大利亚和保加利亚等国家和地区开展临床三期试验，用于治疗糖尿病、肥胖症和超重。（NCT07284901） 2026年01月08日，由福建盛迪医药有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗动脉粥样硬化，为中国化药一类。（CXHL2600039; CXHL2600040; CXHL2600041） 2025年12月25日，由福建盛迪医药有限公司在中国大陆开展临床三期试验，用于治疗体重。（NCT07670884; CTR20254840; CTR20262454） 2025年12月18日，由Kailera Therapeutics Inc在阿根廷、澳大利亚和保加利亚等国家和地区开展临床三期试验，用于治疗肥胖症和超重。（NCT07284875; NCT07284901; NCT07284979） 2025年12月10日，由福建盛迪医药有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗慢性肾功能不全，为中国化药一类。（CXHL2501355; CXHL2501356） 2025年12月02日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗非酒精性脂肪性肝炎。（CXHL2500998; CXHL2500997; CXHL2500996） 2025年09月12日，由福建盛迪医药有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗非酒精性脂肪性肝炎，为中国化药一类。（CXHL2500998; CXHL2500997; CXHL2500996） 2025年09月02日，由福建盛迪医药有限公司向中国国家药品监督管理局NMPA提交上市申请。（CXHS2500110; CXHS2500112; CXHS2500111; CXHS2500107; CXHS2500106; CXHS2500109; CXHS2500108; CXHS2500114; CXHS2500113） 2025年08月14日，由福建盛迪医药有限公司在中国大陆开展临床三期试验，用于治疗糖尿病。（CTR20252475） 2025年07月25日，由福建盛迪医药有限公司在中国大陆开展临床三期试验，用于治疗阻塞性睡眠呼吸暂停综合征。（CTR20251645; NCT06994650; CTR20252002; NCT06974851） 2025年07月14日，由Kailera Therapeutics Inc在美国开展临床一期试验。（NCT07044401） 2025年04月10日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗阻塞性睡眠呼吸暂停综合征。（CXHL2500155; CXHL2500157; CXHL2500156） 2025年04月07日，由福建盛迪医药有限公司在中国大陆开展临床二期试验，用于治疗体重。（NCT06841445） 2025年03月01日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗体重减轻。（NCT07540754; NCT06855147） 2025年02月07日，由福建盛迪医药有限公司向中国国家药品监督管理局NMPA提交IND申请，用于治疗阻塞性睡眠呼吸暂停综合征，为中国化药一类。（CXHL2500155; CXHL2500157; CXHL2500156） 2024年10月31日，由福建盛迪医药有限公司在中国大陆开展临床三期试验，用于治疗二型糖尿病。（CTR20243938; NCT06650007; NCT07060456; CTR20243947; NCT06649344） 2024年09月25日，由福建盛迪医药有限公司在中国大陆开展临床二期试验，用于治疗多囊卵巢综合征。（CTR20243161） 2024年09月01日，由福建盛迪医药有限公司开展临床二期试验，用于治疗多囊卵巢综合征。（NCT06595797） 2024年08月01日，由福建盛迪医药有限公司开展临床二期试验，用于治疗体重。（NCT06565871） 2024年06月04日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗肥胖症和超重。（CTR20241924; NCT07559136; CTR20250659; NCT07150962; NCT06762600; NCT06792955; NCT06435676; CTR20261513; CTR20261414） 2024年05月16日，由Hercules CM NewCo开展临床前研究试验。（https://static.sse.com.cn/disclosure/listedinfo/announcement/c/new/2024-05-17/600276_20240517_URE4.pdf） 2024年05月13日，由福建盛迪医药有限公司在中国大陆开展临床三期试验，用于治疗肥胖症和超重。（CTR20241527; CTR20251645; CTR20262669; NCT06994650; NCT06396429; NCT07285902; NCT07709910; CTR20252002; NCT06974851） 2024年05月06日，由福建盛迪医药有限公司在中国大陆开展临床二期试验，用于治疗舒张期心力衰竭。（NCT06391710） 2024年02月28日，由福建盛迪医药有限公司在中国大陆开展临床一期试验。（CTR20240324） 2023年08月12日，由福建盛迪医药有限公司在中国大陆开展临床二期试验，用于治疗二型糖尿病。（NCT05966272; NCT07599410; CTR20232258; CTR20261854） 2023年06月15日，由福建盛迪医药有限公司在中国大陆开展临床二期试验，用于治疗超重。（CTR20243163; CTR20231528; CTR20233008; CTR20241326; CTR20250596） 2023年06月13日，由福建盛迪医药有限公司在中国大陆开展临床二期试验，用于治疗肥胖症。（NCT05881837; CTR20231528; CTR20233008; NCT06054698; CTR20241326） 2023年05月20日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗糖尿病。（CTR20231383; CTR20250659; CTR20253484; NCT07540754; CTR20244613; CTR20261414; CTR20243984） 2021年12月06日，由福建盛迪医药有限公司在中国大陆开展临床一期试验，用于治疗二型糖尿病。（CTR20241924; CTR20212968; CTR20242520; NCT06506175; NCT06246175; NCT06435676; NCT06723691; NCT05893576; NCT06654960; CTR20222184; NCT05152277; NCT06855147; NCT05516966） 2021年08月09日，由福建盛迪医药有限公司向中国国家药品监督管理局NMPA提交IND申请，为中国化药一类。（CXHL2101377） 9、临床试验 登记号 试验标题 试验药 适应症 原始适应症 申办/合作机构 试验状态 试验分期 开始日期 完成日期 国家/地区 NCT07793929 A Phase 1, Open Label, Parallel Group Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics of Ribupatide in Healthy Participants and in Participants Living With Severe Renal Impairment or End Stage Kidney Disease 瑞普泊肽 终末期肾脏病 | 肥胖 End Stage Renal Disease | Renal Impairment | Obesity | Overweight Kailera Therapeutics, Inc. Not yet recruiting 临床1期 2026-09-08 2028-02-08 美国 NCT07709910 A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis 瑞普泊肽 肥胖 | 膝关节炎 Participants With Obesity and Knee Osteoarthritis 福建盛迪医药有限公司 Not yet recruiting 临床3期 2026-07-01 2028-12-01 中国 NCT07670884 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects 瑞普泊肽 (片剂) 肥胖 Chronic Management of Body Weight 福建盛迪医药有限公司 Recruiting 临床3期 2026-07-24 2027-11-30 中国 NCT07660848 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) HRS-4729 (注射剂) | 瑞普泊肽 (注射剂) 代谢功能障碍相关脂肪性肝炎 Metabolic Dysfunction-Associated Steatohepatitis (MASH) 福建盛迪医药有限公司 Recruiting 临床2期 2026-08-14 2028-07-01 中国 NCT07599410 A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus. 瑞普泊肽 (片剂) 2型糖尿病 T2DM 福建盛迪医药有限公司 Recruiting 临床2期 2026-07-14 2027-07-01 中国 NCT07551492 A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) 瑞普泊肽 (皮下注射) 动脉粥样硬化 Atherosclerotic Cardiovascular Disease 福建盛迪医药有限公司 Recruiting 临床3期 2026-05-29 2031-06-28 中国 CTR20261513 在青少年肥胖参与者中评估HRS9531注射液多次给药的安全性、耐受性、药代动力学和药效学的随机、双盲、安慰剂对照的I期临床研究 瑞普泊肽 (注射液) 肥胖 青少年超重或肥胖 福建盛迪医药有限公司 Recruiting 临床1期 2026-06-03 - 中国 NCT07540754 A Multi-center, Single-dose, Parallel-group, Open-label Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function 瑞普泊肽 (注射剂) 体重下降 | 糖尿病 Diabetes Mellitus | Weight Loss 福建盛迪医药有限公司 Recruiting 临床1期 2026-05-26 2027-02-01 中国 NCT07458269 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes 瑞普泊肽 (皮下注射) 糖尿病 | 肥胖 Obesity Kailera Therapeutics, Inc. Active, not recruiting 临床2期 2026-03-04 2027-06-01 美国 NCT07284901 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes 瑞普泊肽 2型糖尿病 | 糖尿病 | 肥胖 Obesity With Diabetes | Overweight With Diabetes Kailera Therapeutics, Inc. Recruiting 临床3期 2026-01-12 2028-04-24 新西兰 | 美国 | 阿根廷 | 捷克 | 波兰 | 英国 | 保加利亚 | 澳大利亚 | 德国 | 西班牙 NCT07284979 A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes 瑞普泊肽 糖尿病 | 肥胖 Obesity Kailera Therapeutics, Inc. Recruiting 临床3期 2025-12-30 2028-04-01 美国 | 波兰 | 英国 | 保加利亚 | 澳大利亚 NCT07285902 A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of HRS9531 Injection Versus Semaglutide Injection in Subjects With Obesity 瑞普泊肽 (注射剂) 肥胖 Obesity 福建盛迪医药有限公司 Active, not recruiting 临床3期 2025-12-25 2027-03-01 中国 NCT07284875 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes 瑞普泊肽 糖尿病 | 肥胖 Obesity | Overweight Kailera Therapeutics, Inc. Recruiting 临床3期 2025-12-18 2028-03-01 新西兰 | 阿根廷 | 捷克 | 美国 | 波兰 | 英国 | 保加利亚 | 澳大利亚 | 德国 | 西班牙 ChiCTR2500113927 A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of HRS9531 injection in obese subjects with heart failure with preserved ejection fraction 瑞普泊肽 射血分数保留型心力衰竭 | 心脏衰竭 | 慢性心力衰竭 Obese with heart failure with preserved ejection fraction 首都医科大学附属北京安贞医院 Recruiting 临床2期 2024-02-01 2026-04-30 中国 NCT07150962 A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation 瑞普泊肽 (片剂) 超重 | 肥胖 Overweight or Obesity 福建盛迪医药有限公司 Recruiting 临床1期 2025-10-15 2026-09-01 中国 NCT07060456 A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin. 瑞普泊肽 2型糖尿病 Type 2 Diabetes 福建盛迪医药有限公司 Recruiting 临床3期 2025-07-25 2027-03-01 中国 NCT07044401 A Phase 1, Randomized, Open-label, Single-Dose, Crossover Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-9531 Subcutaneous Injection in Participants With a Range of Body Mass Indices 瑞普泊肽 (注射剂, 皮下注射) - Healthy Volunteers Kailera Therapeutics, Inc. Completed 临床1期 2025-07-14 2025-11-13 美国 NCT06994650 A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy 瑞普泊肽 (注射剂, 皮下注射) 阻塞性睡眠呼吸暂停综合征 | 肥胖 Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy 福建盛迪医药有限公司 Recruiting 临床3期 2025-08-13 2027-01-01 中国 NCT06974851 A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Not Receiving Positive Airway Pressure (PAP) Therapy 瑞普泊肽 (注射剂) 阻塞性睡眠呼吸暂停综合征 | 肥胖 Bstructive Sleep Apnea (OSA) and Obesity 福建盛迪医药有限公司 Recruiting 临床3期 2025-07-25 2026-12-01 中国 NCT06855147 A Single-center, Open-label, Phase Ⅰ Clinical Study of the Absorption, Metabolism, and Excretion of [14C]HRS9531 in Healthy Male Subjects 瑞普泊肽 (皮下注射) 2型糖尿病 | 体重下降 Type 2 Diabetes Mellitus | Weight Loss 福建盛迪医药有限公司 Completed 临床1期 2025-04-21 2025-06-17 中国 NCT06841445 A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Tablet in Obese Subjects 瑞普泊肽 (片剂) 肥胖 Chronic Management of Body Weight 福建盛迪医药有限公司 Completed 临床2期 2025-04-07 2026-01-08 中国 NCT06792955 A Single-center, Single-dose, Randomized, Open-label, Single-period, Parallel Bioequivalence Study of HRS9531 Injection Solution in Multi-dose Pens and Single-dose Pens in Overweight/Obese Subjects 瑞普泊肽 (溶液注射剂/注射剂) 肥胖 Overweight/Obesity 福建盛迪医药有限公司 Completed 临床1期 2025-02-11 2025-06-06 中国 NCT06762600 A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of HRS-4729 Injection in Healthy Subjects 对乙酰氨基酚 | HRS-4729 (注射剂, 皮下注射) | 瑞普泊肽 (注射剂, 皮下注射) 肥胖 Overweight or Obesity 福建盛迪医药有限公司 Completed 临床1期 2025-01-16 2026-03-12 中国 NCT06723691 A Single Center, Open-label, Two Cohorts, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects 阿托伐他汀钙 | 华法林钾 | 对乙酰氨基酚 | 地高辛 | 盐酸二甲双胍 | 瑞普泊肽 (注射剂) 2型糖尿病 Type 2 Diabetes 福建盛迪医药有限公司 Completed 临床1期 2024-12-18 2025-06-09 中国 ACTRN12624001397505 A Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy, overweight and obese participants to investigate safety, tolerability and pharmacokinetics of KAI-9531 subcutaneous injection 瑞普泊肽 代谢性疾病 Metabolic diseases | Metabolic diseases | Metabolic and Endocrine - Other metabolic disorders Kailera Therapeutics, Inc. | Avance Clinical Pty Ltd. Completed 临床1期 2024-12-17 2025-05-08 澳大利亚 NCT06654960 A Single Center, Open-label, Single Cohort, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Pharmacokinetics of Metformin in Healthy Subjects 盐酸二甲双胍 (片剂) | 瑞普泊肽 (注射剂) 2型糖尿病 Type 2 Diabetes 福建盛迪医药有限公司 Completed 临床1期 2024-11-05 2024-12-26 中国 NCT06650007 A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone 瑞普泊肽 (注射剂) 2型糖尿病 Diabetes Mellitus, Type 2 福建盛迪医药有限公司 Completed 临床3期 2024-11-08 2026-06-12 中国 NCT06649344 A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors 瑞普泊肽 (注射剂, 皮下注射) 2型糖尿病 Type 2 Diabetes 福建盛迪医药有限公司 Completed 临床3期 2024-10-31 2026-07-18 中国 NCT06595797 A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Polycystic Ovary Syndrome 瑞普泊肽 (注射剂) 多内分泌代谢卵巢综合征 Obese Subjects With Polycystic Ovary Syndrome (PCOS) 福建盛迪医药有限公司 Unknown status 临床2期 2024-09-01 2025-12-01 - NCT06565871 A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea (OSA) 瑞普泊肽 (注射剂, 皮下注射) 阻塞性睡眠呼吸暂停综合征 | 体重下降 | 肥胖 Weight Management 福建盛迪医药有限公司 Unknown status 临床2期 2024-08-01 2025-12-01 - NCT06506175 A Phase I Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants 瑞普泊肽 (片剂) 2型糖尿病 | 体重下降 Weight Management | Type 2 Diabetes 福建盛迪医药有限公司 Not yet recruiting 临床1期 2026-07-01 2026-09-01 中国 NCT06435676 A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects 瑞普泊肽 (片剂) 2型糖尿病 | 肥胖 Overweight or Obesity; Type 2 Diabetes 福建盛迪医药有限公司 Completed 临床1期 2024-06-04 2024-10-08 中国 NCT06396429 Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial 瑞普泊肽 (注射剂) 肥胖 Overweight or Obesity 福建盛迪医药有限公司 Completed 临床3期 2024-05-13 2025-07-07 中国 NCT06391710 A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction 瑞普泊肽 (注射剂, 皮下注射) 射血分数保留型心力衰竭 Heart Failure With Preserved Ejection Fraction 福建盛迪医药有限公司 Active, not recruiting 临床2期 2024-05-06 2026-01-01 中国 NCT06287437 A Single-center, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Effectiveness and Safety of Low-frequency Injection of HRS9531 in Control of Weight Regain in Obese Subjects With and Without Diabetes 瑞普泊肽 (注射给药) 2型糖尿病 | 糖尿病 | 肥胖 | 体重增加 Obesity 复旦大学附属中山医院 Unknown status 临床2期 2024-01-01 2025-12-31 中国 ChiCTR2400081361 A randomized, double-blind, placebo-controlled trial to investigate safety and efficacy of  HRS9531 in patients with PCOS of overweight or obese 瑞普泊肽 多内分泌代谢卵巢综合征 | 肥胖 Polycystic Ovary Syndrom - Not yet recruiting 临床2期 2024-03-01 2025-05-31 中国 NCT06246175 A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of HRS9531injection in Healthy Subjects and Subjects With Impaired Renal Function 瑞普泊肽 (注射剂) 2型糖尿病 | 肾功能不全 | 慢性肾病 Type 2 Diabetes 福建盛迪医药有限公司 Completed 临床1期 2024-02-28 2025-09-02 中国 NCT06054698 A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Overweight or Obese Subjects 瑞普泊肽 (注射剂) 肥胖 Overweight or Obesity 福建盛迪医药有限公司 Completed 临床2期 2023-10-16 2024-09-09 中国 NCT05966272 A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects 瑞普泊肽 (注射剂) 2型糖尿病 Type 2 Diabetes 福建盛迪医药有限公司 Completed 临床2期 2023-08-12 2024-09-24 中国 NCT05893576 A Relative Bioavailability Study of Single-dose, Randomized, Open-label, Single-period, Parallel Design of HRS9531 Injection Using Different Manufacturing Processes in Healthy Subjects 瑞普泊肽 (注射剂) 2型糖尿病 Type 2 Diabetes 福建盛迪医药有限公司 Completed 临床1期 2023-05-15 2023-09-04 中国 NCT05881837 A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes 瑞普泊肽 (注射剂) 肥胖 Overweight or Obesity 福建盛迪医药有限公司 Completed 临床2期 2023-06-13 2024-10-13 中国 NCT05516966 A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus 瑞普泊肽 (皮下注射) 2型糖尿病 Diabetes Mellitus, Type 2 福建盛迪医药有限公司 Completed 临床1期 2022-10-12 2023-05-24 中国 NCT05152277 A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered HRS9531 瑞普泊肽 (皮下注射) 2型糖尿病 Type 2 Diabetes 福建盛迪医药有限公司 Completed 临床1期 2021-12-06 2022-08-24 中国 10、临床结果 标题 登记号 来源 分期 适应症 评价人数 用药方案 结果 评价 发布日期 申办/合作机构 主要研究药物 来源链接 Synapse链接 速递丨减重19.2%！恒瑞医药披露GLP-1/GIP双重受体激动剂中国3期减重研究积极顶线结果 NCT06396429 NEWS 临床3期 超重 | 肥胖 567 HRS9531注射液 2 mg、4 mg、6 mg 体重下降(48周) = 17.7 %  积极 2025-07-16 福建盛迪医药有限公司 瑞普泊肽 https://mp.weixin.qq.com/s?__biz=MzUxMTY5MzM5OQ==&mid=2247578640&idx=3&sn=0546f86699099ed09898967b6df81cad&poc_token=HIa8eWijjEqvdNAAshbNlF0OBi4bdv9GpODIDkJm https://synapse.zhihuiya.com/clinical-result-detail/32885eeea2355aaa00e8505239a0a03a 速递丨减重19.2%！恒瑞医药披露GLP-1/GIP双重受体激动剂中国3期减重研究积极顶线结果 NCT06396429 NEWS 临床3期 超重 | 肥胖 567 Placebo 体重下降(48周): Incidence Rate Ratio = 16.3 积极 2025-07-16 福建盛迪医药有限公司 瑞普泊肽 https://mp.weixin.qq.com/s?__biz=MzUxMTY5MzM5OQ==&mid=2247578640&idx=3&sn=0546f86699099ed09898967b6df81cad&poc_token=HIa8eWijjEqvdNAAshbNlF0OBi4bdv9GpODIDkJm https://synapse.zhihuiya.com/clinical-result-detail/32885eeea2355aaa00e8505239a0a03a 853-P: Efficacy and Safety of a Novel Dual GLP-1/GIP Receptor Agonist (HRS9531), in Obese Adults without Diabetes—Up to 52-Week Treatment - ADA 临床1期 肥胖 249 HRS9531 体重 | 体重下降(32-week) = -3.45 %  积极 2025-06-20 - 瑞普泊肽 https://diabetesjournals.org/diabetes/article/74/Supplement_1/853-P/159922/853-P-Efficacy-and-Safety-of-a-Novel-Dual-GLP-1 | https://diabetesjournals.org/diabetes/article/74/Supplement_1/853-P/159922/853-P-Efficacy-and-Safety-of-a-Novel-Dual-GLP-1?searchresult=1 https://synapse.zhihuiya.com/clinical-result-detail/eaa892d82082d8522d00ad9328509a03 853-P: Efficacy and Safety of a Novel Dual GLP-1/GIP Receptor Agonist (HRS9531), in Obese Adults without Diabetes—Up to 52-Week Treatment - ADA 临床1期 肥胖 249 Placebo 体重 | 体重下降(32-week) = 0.74 %  积极 2025-06-20 - 瑞普泊肽 https://diabetesjournals.org/diabetes/article/74/Supplement_1/853-P/159922/853-P-Efficacy-and-Safety-of-a-Novel-Dual-GLP-1 | https://diabetesjournals.org/diabetes/article/74/Supplement_1/853-P/159922/853-P-Efficacy-and-Safety-of-a-Novel-Dual-GLP-1?searchresult=1 https://synapse.zhihuiya.com/clinical-result-detail/eaa892d82082d8522d00ad9328509a03 Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics Report Positive Topline Data from 8 mg Dose of Phase 2 Obesity Trial of GLP-1/GIP Receptor Dual Agonist HRS9531 NCT06054698 GlobeNewswire 临床2期 肥胖 61 HRS9531 8 mgHRS9531 8 mgHRS9531 8 mg 体重下降(36-week) = 22.8 %  积极 2025-01-13 福建盛迪医药有限公司 瑞普泊肽 https://www.globenewswire.com/news-release/2025/01/13/3008465/0/en/Jiangsu-Hengrui-Pharmaceuticals-and-Kailera-Therapeutics-Report-Positive-Topline-Data-from-8-mg-Dose-of-Phase-2-Obesity-Trial-of-GLP-1-GIP-Receptor-Dual-Agonist-HRS9531.html | https://diabetesjournals.org/diabetes/article/74/Supplement_1/874-P/160124/874-P-Efficacy-and-Safety-of-a-Novel-Dual-GLP-1?searchresult=1 | https://mp.weixin.qq.com/s?__biz=MjM5NDE0MzE2Mw==&mid=2651569129&idx=2&sn=8b690a710a95215e7e45ac7d7e63fc8b https://synapse.zhihuiya.com/clinical-result-detail/28a998922a4a3a04d328e22a28deaad9 Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics Report Positive Topline Data from 8 mg Dose of Phase 2 Obesity Trial of GLP-1/GIP Receptor Dual Agonist HRS9531 NCT06054698 GlobeNewswire 临床2期 肥胖 61 Placebo 体重下降(36-week) = -1.7 %  积极 2025-01-13 福建盛迪医药有限公司 瑞普泊肽 https://www.globenewswire.com/news-release/2025/01/13/3008465/0/en/Jiangsu-Hengrui-Pharmaceuticals-and-Kailera-Therapeutics-Report-Positive-Topline-Data-from-8-mg-Dose-of-Phase-2-Obesity-Trial-of-GLP-1-GIP-Receptor-Dual-Agonist-HRS9531.html | https://diabetesjournals.org/diabetes/article/74/Supplement_1/874-P/160124/874-P-Efficacy-and-Safety-of-a-Novel-Dual-GLP-1?searchresult=1 | https://mp.weixin.qq.com/s?__biz=MjM5NDE0MzE2Mw==&mid=2651569129&idx=2&sn=8b690a710a95215e7e45ac7d7e63fc8b https://synapse.zhihuiya.com/clinical-result-detail/28a998922a4a3a04d328e22a28deaad9 Efficacy and safety of HRS9531, a novel dual GLP-1/GIP receptor agonist, in patients with type 2 diabetes mellitus (T2DM): a phase 2 trial NCT05966272 EASD 临床2期 2型糖尿病 199 HRS9531 1.0 mg HbA1c(20-week) = -2.2 % (95%CI, -2.4 ~ -1.9) 积极 2024-09-09 福建盛迪医药有限公司 瑞普泊肽 https://cattendee.abstractsonline.com/meeting/20620/presentation/2886 https://synapse.zhihuiya.com/clinical-result-detail/3a4e54d35802e948428ee5aa4e89a3ea Efficacy and safety of HRS9531, a novel dual GLP-1/GIP receptor agonist, in patients with type 2 diabetes mellitus (T2DM): a phase 2 trial NCT05966272 EASD 临床2期 2型糖尿病 199 HRS9531 2.0 mg HbA1c(20-week) = -2.6 % (95%CI, -2.8 ~ -2.3) 积极 2024-09-09 福建盛迪医药有限公司 瑞普泊肽 https://cattendee.abstractsonline.com/meeting/20620/presentation/2886 https://synapse.zhihuiya.com/clinical-result-detail/3a4e54d35802e948428ee5aa4e89a3ea Efficacy and Safety of HRS9531, a Novel Dual GLP-1/GIP Receptor Agonist, in Obese Adults—A Phase 2 Trial NCT05881837 ADA 临床2期 肥胖 249 HRS9531 1.0 mg 体重变化(24-week) = -5.4 % (95%CI, -7.3 ~ -3.5) 积极 2024-06-21 福建盛迪医药有限公司 瑞普泊肽 https://diabetesjournals.org/diabetes/article/73/Supplement_1/1861-LB/155203/1861-LB-Efficacy-and-Safety-of-HRS9531-a-Novel?searchresult=1 https://synapse.zhihuiya.com/clinical-result-detail/aed308e9a2d58eea888eea5a3ea22e09 Efficacy and Safety of HRS9531, a Novel Dual GLP-1/GIP Receptor Agonist, in Obese Adults—A Phase 2 Trial NCT05881837 ADA 临床2期 肥胖 249 HRS9531 3.0 mg 体重变化(24-week) = -13.4 % (95%CI, -15.2 ~ -11.5) 积极 2024-06-21 福建盛迪医药有限公司 瑞普泊肽 https://diabetesjournals.org/diabetes/article/73/Supplement_1/1861-LB/155203/1861-LB-Efficacy-and-Safety-of-HRS9531-a-Novel?searchresult=1 https://synapse.zhihuiya.com/clinical-result-detail/aed308e9a2d58eea888eea5a3ea22e09 Safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a dual GLP-1/GIP receptor agonist HRS9531 in T2DM patients NCT05516966 IDF 临床1期 2型糖尿病 63 HRS9531  0.3 mg AE = 84.1% (mostly mild)   积极 2023-12-04 福建盛迪医药有限公司 瑞普泊肽 https://conference.idf.org/cmPortal/Generic/idf23/config/normal/pagetype/eposters/#/PosterDetail/965 https://synapse.zhihuiya.com/clinical-result-detail/22480e0923e3e85090aa8aaa2204e582 Safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a dual GLP-1/GIP receptor agonist HRS9531 in T2DM patients NCT05516966 IDF 临床1期 2型糖尿病 63 HRS9531  1.5 mg AE = 84.1% (mostly mild)   积极 2023-12-04 福建盛迪医药有限公司 瑞普泊肽 https://conference.idf.org/cmPortal/Generic/idf23/config/normal/pagetype/eposters/#/PosterDetail/965 https://synapse.zhihuiya.com/clinical-result-detail/22480e0923e3e85090aa8aaa2204e582 763-P: Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of a Dual GLP-1/GIP Receptor Agonist (HRS9531) in Healthy Subjects—A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose (SAD and MAD) Study NCT05152277 ADA 临床1期 2型糖尿病 90 HRS9531(SAD) AE = The most common adverse events were abdominal distension and nausea in SAD, and urine ketone body present and nausea in MAD; all considered mild to moderate in severity (mostly mild).   积极 2023-06-20 福建盛迪医药有限公司 瑞普泊肽 https://diabetesjournals.org/diabetes/article/72/Supplement_1/763-P/149410/763-P-Safety-Tolerability-Pharmacokinetics-PK-and?searchresult=1 | https://diabetesjournals.org/diabetes/article/72/Supplement_1/763-P/149410/763-P-Safety-Tolerability-Pharmacokinetics-PK-and https://synapse.zhihuiya.com/clinical-result-detail/988488954502ad22eed922a00e052285 763-P: Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of a Dual GLP-1/GIP Receptor Agonist (HRS9531) in Healthy Subjects—A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose (SAD and MAD) Study NCT05152277 ADA 临床1期 2型糖尿病 90 HRS9531(MAD) AE = The most common adverse events were abdominal distension and nausea in SAD, and urine ketone body present and nausea in MAD; all considered mild to moderate in severity (mostly mild).   积极 2023-06-20 福建盛迪医药有限公司 瑞普泊肽 https://diabetesjournals.org/diabetes/article/72/Supplement_1/763-P/149410/763-P-Safety-Tolerability-Pharmacokinetics-PK-and?searchresult=1 | https://diabetesjournals.org/diabetes/article/72/Supplement_1/763-P/149410/763-P-Safety-Tolerability-Pharmacokinetics-PK-and https://synapse.zhihuiya.com/clinical-result-detail/988488954502ad22eed922a00e052285 11、转化医学 研究 亮点 主题 期刊/会议 出版日期 药物 适应症 机构 2648-P: A Phase 1, Randomized, Double-Blind, Single-Ascending Dose Study of KAI-9531, a Novel Dual GLP-1/GIP Receptor Agonist in Development for People Living with Overweight/Obesity - 1期临床研究 ADA 2026 2026-06-20 瑞普泊肽 肥胖 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 Tablet, an Oral Dual GLP-1/GIP Receptor Agonist, in Healthy Participants—A Phase 1 Study - 1期临床研究 ADA 2025 2025-06-20 瑞普泊肽 代谢性疾病 - Safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a dual GLP-1/GIP receptor agonist (HRS9531) in healthy subjects 本研究旨在评估双重GLP-1/GIP受体激动剂HRS9531在健康受试者中的安全性、耐受性、药代动力学和药效动力学。结论显示，HRS9531耐受性良好，药代动力学良好，并显著降低血糖和减轻体重。这些数据支持HRS9531在治疗T2DM和肥胖等代谢相关疾病的进一步临床开发。研究结果显示，HRS9531剂量依赖性降低空腹血糖和体重，并且在安全性和耐受性方面呈现良好表现。 1期临床研究 EASD 2023 2023-10-04 瑞普泊肽 代谢性疾病 江苏恒瑞医药股份有限公司 | Central Hospital Affiliated to Shandong First Medical University, Jinan, China Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of a Dual GLP-1/GIP Receptor Agonist (HRS9531) in Healthy Subjects—A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose (SAD and MAD) Study 本研究旨在评估双重GLP-1/GIP受体激动剂HRS9531在健康受试者中的安全性、耐受性、药代动力学和药效动力学。研究结果显示，HRS9531在单剂和多剂情况下均表现出良好的耐受性和安全性，药物暴露与剂量成正比，能显著降低空腹血糖水平，并导致明显的体重减轻。因此，这些数据支持HRS9531在2型糖尿病和肥胖等代谢相关疾病的临床进一步开发。 1期临床研究 ADA 2023 2023-06-20 瑞普泊肽 代谢性疾病 江苏恒瑞医药股份有限公司 12、适应症及进展 适应症 进展 最新进展日期 2型糖尿病 申请上市 2026-09-10 肥胖 申请上市 2026-10-01 动脉粥样硬化 III期 2026-06-08 膝骨关节炎 III期 2026-07-17 阻塞型睡眠呼吸暂停 III期 2026-01-29 多囊卵巢综合征 II期 2026-06-09 代谢功能障碍相关脂肪性肝炎 II期 2026-08-25 射血分数保持的心力衰竭 II期 2025-12-04 糖尿病 I期 2026-05-29 慢性肾脏病 批准临床 2026-02-12 降低心血管风险 批准临床 2026-03-19 肥胖合并症 批准临床 2026-06-10