A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in patients with type 2 diabetes mellitus inadequately controlled with metformin and dapagliflozin

开始日期2026-02-01

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

NCT06174779

/ Active, not recruiting临床3期

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus

开始日期2024-01-03

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

NCT03770728

/ Terminated临床3期

A 30-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea

Primary Objective:
To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU).
Secondary Objectives:
* To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control.
* To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight.
* To evaluate the safety of once weekly injection of efpeglenatide.

开始日期2019-08-01

申办/合作机构

Sanofi

[+1]

100 项与 Efpeglenatide 相关的临床结果

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100 项与 Efpeglenatide 相关的转化医学

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100 项与 Efpeglenatide 相关的专利（医药）

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项与 Efpeglenatide 相关的文献（医药）

2026-01-01·DIABETES OBESITY & METABOLISM

Comparison of the renal outcomes of novel antidiabetic agents in patients with type 2 diabetes with chronic kidney disease: A systematic review and network meta‐analysis of randomized controlled trials

Review

作者: Rong Lin MD ; Kuo-Liong Chien PhD ; Ming-Chieh Shih PhD ; Chia-Li Hsu MD ; Hon-Yen Wu PhD

Abstract:

Aims:

To investigate the renal outcomes of dipeptidyl peptidase 4 (DPP‐4) inhibitors, glucagon‐like peptide‐1 (GLP‐1) receptor agonists, and sodium‐glucose transport protein‐2 (SGLT‐2) inhibitors in patients with type 2 diabetes mellitus (T2DM) with chronic renal disease (CKD).

Materials and Methods:

PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov were searched through July 2025 for randomized controlled trials with ≥24 weeks of follow‐up in patients with T2DM and CKD. Outcomes included composite renal outcome, estimated glomerular filtration rate (eGFR), and urinary albumin‐to‐creatinine ratio (UACR). A network meta‐analysis was conducted, and the certainty of evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation used to evaluate evidence certainty (GRADE).

Results:

Twenty RCTs enrolling 80,670 participants were included. Compared with placebo, several agents significantly reduced composite renal outcomes, with dapagliflozin 10 mg showing the greatest efficacy (OR 0.55, 95% CI 0.42–0.72; high‐certainty evidence), followed by canagliflozin, empagliflozin, efpeglenatide, sotagliflozin 400 mg, semaglutide, and dulaglutide 1.5 mg. Canagliflozin 100–300 mg significantly reduced UACR, whereas dapagliflozin had no effect. None of the novel antidiabetic agents significantly altered eGFR. Certainty of evidence ranged from high for placebo‐controlled comparisons to low or very low for indirect estimates.

Conclusions:

In patients with T2DM and CKD, SGLT2 inhibitors provide the most consistent renal protection, while GLP‐1 receptor agonists offer additional but variable benefits. Dapagliflozin showed the greatest efficacy, and canagliflozin most strongly reduced albuminuria, highlighting meaningful heterogeneity across agents. DPP‐4 inhibitors conferred no renal benefit. Overall, evidence from placebo‐controlled trials was robust, whereas certainty was lower for indirect estimates, highlighting the need for drug‐specific evaluation in clinical practice.

2025-11-01·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Cardiovascular Effects and Tolerability of GLP-1 Receptor Agonists

Review

作者: Federici, Massimo ; Angiolillo, Dominick J ; Bernardi, Marco ; Sciarretta, Sebastiano ; Simeone, Beatrice ; Benenati, Stefano ; Ortega-Paz, Luis ; Rocco, Erica ; Greco, Ernesto ; Spadafora, Luigi ; Mehran, Roxana ; Crea, Filippo ; Laudani, Claudio ; Sarto, Gianmarco ; Frati, Giacomo ; D'Amario, Domenico ; Galli, Mattia

BACKGROUND:

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have demonstrated significant cardiovascular (CV) benefits, particularly in patients with diabetes mellitus, but the safety and efficacy of different GLP-1 RAs across diverse populations remain insufficiently defined.

OBJECTIVES:

Previous meta-analyses of GLP-1 RAs have been limited by restricted populations, omission of recent trials, or incomplete safety synthesis; this study integrates the latest evidence across 21 randomized controlled trials and diverse populations using advanced meta-analytic methods.

METHODS:

Randomized controlled trials comparing GLP-1 RAs vs controls or placebo were included. Analyses were conducted in prespecified subgroups based on the GLP-1 RA used. Prespecified subgroups according to diabetes mellitus, kidney function, obesity, or heart failure were also performed. Main outcomes comprised mortality (all-cause and CV), trial-defined major adverse cardiovascular events (MACE) and serious adverse events. GRADE (Grading of Recommendations Assessment, Development and Evaluation) and trial sequential analyses were performed to evaluate certainty and conclusiveness of findings, respectively.

RESULTS:

A total of 21 trials encompassing 99,599 patients were included. Eight different GLP-1 RAs were used (lixisenatide, liraglutide, exenatide, semaglutide, efpeglenatide, dulaglutide, albiglutide, and tirzepatide), each administered at therapeutic doses and compared vs placebo or controls. Mean follow-up duration was 2.4 years. We found conclusive, high-certainty evidence that GLP-1 RAs reduced all-cause death (incidence rate ratio [IRR]: 0.88; 95% CI: 0.84-0.92; needed to treat [NNT] = 121), CV death (IRR: 0.87; 95% CI: 0.81-0.92; NNT = 170), and MACE (IRR: 0.87; 95% CI: 0.83-0.91; NNT = 66), compared with controls. GLP-1 RAs reduced serious adverse events (-9%), myocardial infarction (-15%), acute kidney failure (-9%), heart failure (-15%), and infections (-10%), but increased gastrointestinal (+63%) and gallbladder (+26%) disorders. There were no differences in stroke, pancreatitis, or neoplasm between groups. Results were mostly consistent across subgroups. Analysis by GLP-1 RA type revealed potential differences in efficacy and safety profiles.

CONCLUSIONS:

GLP-1 RAs reduce mortality and MACE in high-risk populations, highlighting benefits beyond glycemic control. These come at increased gastrointestinal and gallbladder risks. Variation in efficacy and tolerability supports tailoring GLP-1 RA therapy to individual patient characteristics and treatment goals. (PROSPERO [GLP-1 RAs Reduce Mortality and Cardiovascular Events Across the Spectrum of Treated Patients: A Systematic Review and Meta-Analysis]; CRD420251032222).

2025-08-01·DIABETES CARE

Effect of Efpeglenatide on Heart Failure Outcomes: A Participant-Level Exploratory Analysis of the Randomized AMPLITUDE-O Trial

Letter

作者: Lopes, Renato D. ; Del Prato, Stefano ; Branch, Kelley R.H. ; Pratley, Richard ; Rosenstock, Julio ; Lam, Carolyn S.P. ; Sattar, Naveed ; Islam, Shofiqul ; Gerstein, Hertzel C.

项与 Efpeglenatide 相关的新闻（医药）

2026-01-28

·PRNewswire

Hanmi Secures Export Deal with Mexican Partner Sanfer for GLP-1 Obesity Drug and More

Hanmi Signs Exclusive Partnership with New Mexican Partner Laboratorios Sanfer, Covering Efpeglenatide and Diabetes Treatments SEOUL, South Korea, Jan. 27, 2026 /PRNewswire/ -- Hanmi is accelerating its global market entry with efpeglenatide, Korea's first domestically developed GLP-1 class obesity and metabolic disease treatment. Hanmi Pharmaceutical, the core operating company of Hanmi Science, announced on January 28 that it has signed an exclusive distribution agreement with Mexican pharmaceutical company Laboratorios Sanfer for efpeglenatide, its GLP-1 obesity therapy, as well as the Dapalon Family, Hanmi's flagship diabetes treatment portfolio (Dapalon Tab. and Dapalon Duo SR Tab.). Under the agreement, Hanmi will supply efpeglenatide and the Dapalon Family, while Laboratorios Sanfer will be responsible for regulatory approval, marketing, distribution, and sales within Mexico. Mexico is one of the countries with the highest obesity rates globally, with obesity prevalence reaching 36.86%, while diabetes prevalence stands at 16.4%.[1] As demand in the market extends beyond weight loss and maintenance therapy to include blood glucose management, the agreement reflects confidence in efpeglenatide's global scalability and strategic value. Founded in 1941, Sanfer is Mexico's largest privately held pharmaceutical company. Leveraging its extensive sales and distribution network across Latin America and its in-house R&D capabilities, Sanfer has established itself as a leading pharmaceutical company in the region. The company operates in more than 20 countries across Latin America as well as in the United States and recently strengthened its position as Mexico's largest biopharmaceutical company through the acquisition of Probiomed. The partnership is expected to gradually expand collaboration across efpeglenatide and other metabolic disease treatments, including additional product launches and joint marketing strategies over the mid- to long term. Ricardo Amtmann, CEO of Sanfer, stated, "As a leading pharmaceutical company in Mexico and Latin America, our vision is to improve patients' lives through innovative, high-quality products. With healthcare costs accounting for 34.6% of household spending in Mexico, improving accessibility to innovative treatments is critical.[2] Hanmi's efpeglenatide and diabetes treatment portfolio meet these needs." He added, "Through this partnership, we aim to contribute to addressing the rapidly growing challenges of obesity and diabetes in Mexico." Jae-hyun Park, CEO of Hanmi Pharmaceutical, said, "This agreement marks an important milestone that demonstrates Hanmi's formulation capabilities and R&D competitiveness on the global stage. As the Mexican government places greater emphasis on standardizing healthcare services and strengthening the management of chronic diseases, we find it especially meaningful that Hanmi's independently developed, Korea's first GLP-1–based obesity and metabolic disease treatment, together with our innovative diabetes treatment portfolio, will be able to contribute to improving the health of the Mexican population." Meanwhile, Hanmi completed its regulatory application for efpeglenatide to the Ministry of Food and Drug Safety on December 17, 2025. In September 2025, the company also submitted an IND for a Phase 3 clinical trial evaluating combination therapy with SGLT-2 inhibitors and metformin, which was approved on January 21, 2026. Hanmi is pursuing an expansion of efpeglenatide's indications from obesity into diabetes, with obesity approval targeted for the second half of 2026 and an additional diabetes indication planned for 2028. Contact info: Official Websites: , [email protected], +82-02-410-0467 SOURCE Hanmi Pharmaceutical 21% more press release views with Request a Demo

并购临床3期

2025-04-13

·医学新视点

糖尿病患者心肾风险降低多达58%！三联疗法或为临床治疗新选择

▎药明康德内容团队编辑胰高血糖素样肽-1受体激动剂（GLP-1RA）已被证实具有很大治疗潜力，包括降糖、减重，以及降低重大心血管不良事件风险和改善糖尿病患者肾脏预后。近期研究证据显示，GLP-1RA或有益于改善射血分数保留型心力衰竭（HFpEF）的患者的肾脏结局。部分大型临床试验亚组分析结果表明，GLP-1RA和钠-葡萄糖共转运蛋白2抑制剂（SGLT-2i）联合治疗，可减少糖尿病患者心力衰竭住院和肾脏疾病复合事件发生率。在此基础上加用非甾体盐皮质激素受体拮抗剂（MRA）非奈利酮，可能进一步强化心肾保护作用，相关研究结果显示，三联治疗预估可将心血管不良事件风险和慢性肾病进展风险分别降低35%和58%。但GLP-1RA+SGLT-2i+非奈利酮三联疗法的临床效益及适用人群仍需更多研究验证。GLP-1RA可降低糖尿病患者主要不良心血管事件发生风险和肾脏不良结局风险糖尿病是心血管疾病和慢性肾病最重要的危险因素之一。相比于无糖尿病患者，糖尿病患者罹患动脉粥样硬化性心血管疾病的风险高出2~4倍。慢性肾病是糖尿病的主要微血管并发症，会增加心血管疾病和死亡的风险。控制血糖水平有助于预防慢性肾病微血管并发症和心血管事件的发生。对于糖尿病合并心血管疾病或存在多种心血管和肾脏风险的患者，GLP-1RA是治疗可选择用药之一。LEADER试验纳入了2型糖尿病合并心血管高风险的患者9340例，研究人员将患者随机分配接受利拉鲁肽或安慰剂治疗。研究结果显示，平均随访3.8年，相比于安慰剂组，利拉鲁肽组患者的主要不良心血管事件（心血管死亡、非致死性心肌梗死或非致死性卒中的复合终点）减少了13%（HR=0.87）。SUSTAIN-6试验则显示，在2型糖尿病合并心血管高风险患者中，相比于安慰剂组，司美格鲁肽组（皮下注射，每周0.5 mg或1 mg）心血管不良事件风险降低26%（HR=0.74），卒中风险降低了26%。后续Harmony Outcomes、REWIND、AMPLITUDE-O等研究也证实了GLP-1RA在降低2型糖尿病合并心血管高风险患者心血管不良事件、心肌梗死和卒中风险方面的作用。GLP-1RA不仅具有降糖的作用，也具有减重效应。SELECT试验在肥胖[体重指数（BMI）≥27 kg/m2]合并心血管疾病但无糖尿病的患者中开展，探索使用GLP-1RA对于预防心血管事件发生的作用。研究结果显示，在平均3.3年的观察期内，相比于安慰剂，皮下注射司美格鲁肽可使患者体重较基线降低9.39%、心血管不良事件风险降低20%（HR=0.80），尤其是心肌梗死风险降低28%（HR=0.72）。该研究结果提示，GLP-1RA心血管保护作用与减重相关，而非降糖作用。荟萃分析结果表明，GLP-1RA可将糖尿病合并心血管高风险患者的心力衰竭住院率降低约10%。但关于GLP-1RA降低心力衰竭住院风险的研究结果并不完全一致。FIGHT试验纳入因急性心力衰竭住院的射血分数降低的心力衰竭患者300例。所有患者中位左心室射血分数为25%；82%患有缺血性心脏病、59%患有2型糖尿病。结果显示，利拉鲁肽组与安慰剂组死亡（HR=1.10）和心力衰竭再住院（HR=1.30）风险无显著差异，不同糖尿病状态亚组分析结果也相似。因此，关于射血分数降低的心力衰竭患者能否从GLP-1RA用药中获益，仍有待更多证据进行验证。GLP-1RA改善肾脏结局获益的证据多来源于次要结局或探索性分析，其机制可能与大量蛋白尿进展抑制有关，但对其他临床重要肾脏终点的影响尚不明确，包括肾小球滤过率（eGFR）下降速度、开始肾脏替代治疗的时间等。FLOW试验评估皮下注射司美格鲁肽对2型糖尿病患者慢性肾病影响，研究纳入患者3533例，随机接受司美格鲁肽或安慰剂治疗。主要结局为首次肾功能衰竭的时间（持续eGFR<15 ml/min/1.73m2或开始慢性肾脏替代治疗）。研究结果显示，司美格鲁肽组eGFR较基线下降≥50%或因肾脏或心血管原因死亡风险较低（HR=0.76）。肾脏替代治疗的开始时间延迟，但未达到统计学意义（HR=0.84）。因此，司美格鲁肽或可影响2型糖尿病合并慢性肾病患者的临床肾脏终点。GLP-1RA和SGLT-2i的潜在互补证据一项比较GLP-1RA与SGLT-2i疗效的荟萃分析中，纳入5项GLP-1RA相关和3项SGLT-2i相关试验，涉及77242例患者。与安慰剂组相比，GLP-1RA组的心血管不良事件风险降低了12%（HR=0.88），SGLT-2i组的心血管不良事件风险降低了11%（HR=0.89），这表明GLP-1RA和SGLT-2i降低心血管不良事件风险的程度相似。此外，多项荟萃分析结果显示，无论是否患有糖尿病，SGLT2i在射血分数降低的心力衰竭和射血分数保留的心力衰竭中都能将心力衰竭住院降低约30%。GLP-1RA联合SGLT-2i能否进一步降低糖尿病患者的心血管和肾脏事件的发生？理论上来说是可行的，但尚缺乏相关试验来直接验证联合疗法的效果。此前，AMPLITUDE-O试验和Harmony Outcomes试验分别有15.2%（n=618）和6.1%（n=575）的患者在基线时使用SGLT-2i。AMPLITUDE-O试验事后分析发现，基线时SGLT-2i使用者和未使用者的心血管不良事件风险分别降低了30%和26%（HR=0.70和0.74，相互作用P=0.70）、心力衰竭住院风险分别降低了77%和30%（HR=0.23和0.70，相互作用P=0.35）、复合肾脏结局风险分别降低了48%和30%（HR=0.52和0.70，相互作用P=0.38）。Harmony Outcomes试验事后分析未对肾脏结局进行探讨，但也观察到了类似的结果。DECLARE-TIMI 58试验中，4.4%患者基线时使用GLP-1RA，结果显示，SGLT-2i（达格列净）可降低心血管不良事件、心力衰竭住院和复合肾脏结局的风险，这种作用与基线是否使用GLP-1RA无关。从现有研究来看，GLP-1RA和SGLT-2i的作用机制基本上是独立的，但仍需要进一步研究，以评估二者联合治疗是否能够带来更大的临床益处。GLP-1RA+SGLT-2i+非奈利酮的三联治疗策略FIDELIO-DKD、FIGARO-DKD及FIDELITY试验表明，非奈利酮可减少慢性肾病合并糖尿病患者的心血管和肾脏事件发生率，这主要得益于非奈利酮可降低心力衰竭住院风险。这3项大型临床试验的FINE-HEART汇总分析中，非奈利酮降低了心力衰竭住院、白蛋白尿进展复合终点（排除心血管事件影响）、心血管不良事件和全因死亡的风险。参与者中，基线分别有5.8%和8.9%的患者使用GLP-1RA和SGLT-2i，无论这些药物的使用情况如何，非奈利酮对心血管死亡的治疗效果都是一致的。非奈利酮对心血管和肾脏事件的临床益处也不太可能受到GLP-1RA或SGLT-2i联合治疗的影响。但关于非奈利酮联合GLP-1RA和SGLT-2i的附加作用的临床证据仍然有限。有学者将GLP-1RA、SGLT-2i和非奈利酮的相关临床试验数据进行交叉试验分析，以估计三联治疗的效果。研究结果显示，在糖尿病和蛋白尿患者中，相比于常规治疗，三联治疗组的心血管不良事件、心力衰竭住院和慢性肾病进展的风险分别降低了35%（HRs=0.65）、55%（HRs=0.45）和58%（HRs=0.42）。从结果来看，潜在原因是GLP-1RA、SGLT-2i和非甾体MRA的作用机制通常互补和独立、可能部分重叠。因此，这三类药物结合时的效果可能相加。此外，研究还发现，对于50岁以上的患者，相比于单独使用常规疗法，采用三联疗法治疗的患者心血管不良事件、心力衰竭住院和慢性肾病的无事件生存期分别延长了3.2年、3.2年和5.5年。这提示，相比传统疗法或单独用药，GLP-1RA、SGLT-2i和非奈利酮的三联疗法具有更强的心肾保护作用。鉴于现有证据，三联疗法有望提供额外的心脏保护，但需要开展进一步的随机对照试验，以明确三联疗法是否具有相加或协同作用。总结和未来前景联合用药可能进一步增强治疗效果，根据患者情况选择合适药物是未来心血管-肾脏代谢综合征领域的精准治疗方向。2型糖尿病和/或肥胖患者可能受益于联合用药，并改善心血管和肾脏结局。GLP-1RA+SGLT-2i+非奈利酮的方案，可能在心血管和肾脏保护方面具有互补作用。但治疗策略的制定仍需考虑到以下几方面的差异：1）明确从联合治疗中获益的人群；2）明确加强治疗的理想时机和优先级，因为目前的证据不足以弥补这一空白；3）患者接受联合治疗如何维持长期依从性和安全性。本文作者：泰达国际心血管病医院郑刚推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料（可上下滑动查看）[1] Wong ND, Sattar N. Cardiovascular risk in diabetes mellitus: epidemiology, assessment and prevention. Nat Rev Cardiol. 2023;20(10):685–95. [2] Vaduganathan M, Mensah GA, Turco JV, et al. The global burden of cardiovascular diseases and risk: a compass for future health. J Am Coll Cardiol. 2022;80(25):2361–71. [3] Cea Soriano L, Johansson S, Stefansson B, et al. Cardiovascular events and all-cause mortality in a cohort of 57,946 patients with type 2 diabetes: associations with renal function and cardiovascular risk factors. Cardiovasc Diabetol. 2015;14:38. [4] de Boer IH, Khunti K, Sadusky T, et al. Diabetes management in chronic kidney disease: a consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO). Diabetes Care. 2022;45(12):3075–90. [5] American Diabetes Association Professional Practice C: 11. Chronic kidney disease and risk management: standards of care in diabetes-2024. Diabetes Care 2024, 47(Suppl 1):S219-S230. [6] Bornfeldt KE. Does elevated glucose promote atherosclerosis? Pros and Cons Circ Res. 2016;119(2):190–3. [7] Gaede P, Vedel P, Larsen N, et al. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383–93. [8] Ueki K, Sasako T, Okazaki Y, et al. Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial. Lancet Diabetes Endo crinol. 2017;5(12):951–64. [9] Gaede P, Lund-Andersen H, Parving HH, et al. Effect of a mul tifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580–91. [10] Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Associa tion (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753–86. [11] Agarwal R, Filippatos G, Pitt B, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43(6):474–84. [12] Bjorkegren JLM, Lusis AJ. Atherosclerosis: recent developments. Cell. 2022;185(10):1630–45. [13] Abel ED, Gloyn AL, Evans-Molina C, et al. Diabetes mellitus-progress and opportunities in the evolving epidemic. Cell. 2024;187(15):3789–820. [14] Ritchie RH, Abel ED. Basic mechanisms of diabetic heart disease. Circ Res. 2020;126(11):1501–25. [15] van Raalte DH, Bjornstad P, Cherney DZI, et al. Combination therapy for kidney disease in people with diabetes mellitus. Nat Rev Nephrol. 2024;20(7):433–46. [16] Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–22. [17] Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular out comes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834–44. [18] Hernandez AF, Green JB, Janmohamed S, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-con trolled trial. Lancet. 2018;392(10157):1519–29. [19] Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo controlled trial. Lancet. 2019;394(10193):121–30. [20] Gerstein HC, Sattar N, Rosenstock J, et al. Cardiovascular and renal outcomes with efpeglenatide in type 2 diabetes. N Engl J Med. 2021;385(10):896–907. [21] Ussher JR, Drucker DJ. Glucagon-like peptide 1 receptor agonists: cardiovas cular benefits and mechanisms of action. Nat Rev Cardiol. 2023;20(7):463–74. [22] Giugliano D, Scappaticcio L, Longo M, et al. GLP-1 receptor agonists and cardiorenal outcomes in type 2 diabetes: an updated meta-analysis of eight CVOTs. Cardiovasc Diabetol. 2021;20(1):189. [23] Sattar N, Lee MMY, Kristensen SL, et al. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of randomised trials. Lancet Diabetes Endocrinol. 2021;9(10):653–62. [24] Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015;373(23):2247–57. [25] Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389(24):2221–32. [26] Sawami K, Tanaka A, Node K. Anti-obesity therapy for cardiovascular disease prevention: potential expected roles of glucagon-like peptide-1 receptor agonists. Cardiovasc Diabetol. 2022;21(1):176. [27] Margulies KB, Hernandez AF, Redfield MM, et al. Effects of liraglutide on clinical stability among patients with advanced heart failure and reduced ejection fraction: a randomized clinical trial. JAMA. 2016;316(5):500–8. [28] Jorsal A, Kistorp C, Holmager P, et al. Effect of liraglutide, a glucagon like peptide-1 analogue, on left ventricular function in stable chronic heart failure patients with and without diabetes (LIVE)-a multicentre, double-blind, randomised, placebo-controlled trial. Eur J Heart Fail. 2017;19(1):69–77. [29] Kosiborod MN, Abildstrom SZ, Borlaug BA, et al. Semaglutide in patients with heart failure with preserved ejection fraction and obesity. N Engl J Med. 2023;389(12):1069–84. [30] Kosiborod MN, Petrie MC, Borlaug BA, et al. Semaglutide in patients with obesity-related heart failure and type 2 diabetes. N Engl J Med. 2024;390(15):1394–407. [31] Perkovic V, Tuttle KR, Rossing P, et al. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. N Engl J Med. 2024;391(2):109–21. [32] Kosiborod MN, Deanfield J, Pratley R, et al. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024;404(10456):949–61. [33] Petrie MC, Borlaug BA, Butler J, et al. Semaglutide and NT-proBNP in obesity-related HFpEF. J Am Coll Cardiol. 2024;84(1):27–40. [34] Verma S, Petrie MC, Borlaug BA, et al. Inflammation in obesity-related HFpEF: The STEP-HFpEF Program. J Am Coll Cardiol. 2024;84(17):1646–62.免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。分享，点赞，在看，传递医学新知

临床结果临床成功

2024-11-06

·PipelineReview

Hanmi Unveils Novel Obesity Drug 'HM17321' : A Game-Changer in Overcoming GLP-1-Associated Muscle Loss

Fat Loss Augmentation + Lean Mass Increase Hanmi Presents Three Breakthrough Findings on Novel Obesity Drugs at 2024 ObesityWeek High Quality Obesity Management by Targeting the CRF2 Receptor: Enhanced Fat Loss with Lean Mass Increase Improved Weight Loss and Muscle Preservation with HM15275 Combination Therapy SEOUL, South Korea I November 6, 2024 I Hanmi Pharm. Co., Ltd. has announced promising research results for its novel obesity treatment, HM17321. This groundbreaking drug not only augments fat loss but also significantly increases lean muscle mass, marking it as a potential game-changer in obesity management. HM17321 addresses a key limitation in current GLP-1-based therapies, which often lead to muscle loss as a side effect of significant weight reduction. “HM17321 is the novel concept of obesity drug developed combining advanced artificial intelligence and structural modeling technology with Hanmi’s innovative R&D expertise,” said Dr. In Young Choi, Head of Hanmi’s R&D Center. “It selectively reduces fat while increasing muscle, establishing a new paradigm for high quality obesity treatment. The drug shows significant promise as both monotherapy and combination therapy to improve weight loss potency and quality,” he added. As a peptide-based therapy, HM17321 is anticipated to provide a more cost-effective alternative to antibody-based muscle-preserving drugs, such as myostatin-targeting monoclonal antibodies (mAbs), while also demonstrating enhanced compatibility with incretin-based obesity treatments. Hanmi unveiled its latest findings at 2024 ObesityWeek, an annual obesity-focused conference held in San Antonio, Texas, from November 3 to 6. Hanmi presented two preclinical studies in poster format, underscoring HM17321’s double-action(fat loss and lean muscle gain) benefits and a development strategy that highlights both quantitative and qualitative improvements in weight loss. Unlike conventional incretin-based drugs, HM17321 targets the CRF2 (Corticotropin-Releasing Factor 2) receptor to selectively reduce fat while enhancing muscle mass. This unique approach sets it apart from existing therapies. Current GLP-1-based obesity medications are effective in achieving 15-20% weight loss, but up to 40% of this loss can come from muscle, accompanied by a reduction in basal metabolic rate and a high risk of rapid weight regain (the “yo-yo” effect) after discontinuation. Hanmi reported at the conference that, in animal models, HM17321 achieved weight loss levels comparable to semaglutide, a prominent GLP-1-based therapy, but with the added benefit of increased lean body and muscle mass. This capability makes HM17321 a first-in-class drug, providing a differentiated strategy to high quality weight management by focusing on both fat loss and muscle enhancement simultaneously. In addition to HM17321, Hanmi presented a separate study on the combined use of HM17321 with HM15275, a next-generation anti-obesity drug (LA-GLP/GIP/GCG), and semaglutide. The combination therapy demonstrated a substantial reduction in body weight and fat mass compared to monotherapies, effectively preventing the muscle loss that accompanies significant weight loss treatments. These findings underscore HM17321’s role in improving the quality of weight loss by reducing fat, increasing muscle mass, and enhancing muscle function, making it advantageous in both monotherapy and combination therapies. Hanmi also presented follow-up nonclinical data on HM15275(LA-GLP-1/GIP/GCG), previously unveiled at the American Diabetes Association (ADA) conference. This novel anti-obesity candidate not only demonstrates potential for over 25% weight loss with minimal muscle loss but also offers therapeutic benefits for metabolic diseases. At 2024 ObesityWeek, Hanmi highlighted HM15275’s mechanism of action, which facilitates favorable metabolic phenotype change and enhances energy metabolism alongside dietary control. These effects clearly highlight how HM15275 could distinguish itself from current incretin-based obesity drugs, which primarily rely on appetite suppression. HM15275 is currently in Phase 1 clinical trials in the United States, with plans to progress to Phase 2 trials by 2025, positioning it as a ‘best-in-class’ candidate in obesity treatment. Reflecting on these innovative R&D achievements, Dr. Choi stated, “This year, Hanmi has fortified its leadership in obesity treatment through the unveiling of HM17321 and HM15275. These innovations continue the momentum started by efpeglenatide within our H.O.P project. Our commitment to pioneering R&D will drive unprecedented advancements in obesity treatment, addressing challenges once thought insurmountable.” Official Website: www.hanmipharm.com SOURCE: Hanmi Pharmaceutical

临床1期临床结果

100 项与 Efpeglenatide 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11947	-	-	DB15650

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肥胖	临床3期	韩国	Hanmi Pharmaceutical Co., Ltd.	2024-01-03
2型糖尿病	临床3期	美国	Hanmi Pharmaceutical Co., Ltd.	2017-12-05
2型糖尿病	临床3期	美国	Sanofi	2017-12-05
2型糖尿病	临床3期	德国	Sanofi	2017-12-05
2型糖尿病	临床3期	德国	Hanmi Pharmaceutical Co., Ltd.	2017-12-05
2型糖尿病	临床3期	波兰	Sanofi	2017-12-05
2型糖尿病	临床3期	波兰	Hanmi Pharmaceutical Co., Ltd.	2017-12-05
2型糖尿病	临床3期	乌克兰	Hanmi Pharmaceutical Co., Ltd.	2017-12-05
2型糖尿病	临床3期	乌克兰	Sanofi	2017-12-05
2型糖尿病	临床3期	英国	Sanofi	2017-12-05

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03496298 (AMPLITUDE-O, Pubmed \| Circulation)	临床3期	2型糖尿病	4,076	Placebo	製鬱顧製範選夢鬱構餘(窪淵築繭構鏇襯網鹹積) = 襯鏇積齋觸糧鑰鏇淵餘鏇積顧衊鏇範醖淵觸範 (鑰築範壓齋壓鬱壓醖醖 )	-	2023-02-20
				Efpeglenatide 4 mg	製鬱顧製範選夢鬱構餘(窪淵築繭構鏇襯網鹹積) = 願醖艱窪憲積齋餘遞鬱鏇積顧衊鏇範醖淵觸範 (鑰築範壓齋壓鬱壓醖醖 )
NCT03353350 (AMPLITUDE-M, Pubmed)	临床3期	2型糖尿病	406	Efpeglenatide 2 mg	蓋膚鏇鬱鹽齋築鹽顧願(鏇壓餘糧憲鏇鹹構鑰築) = 遞簾艱獵夢夢願繭齋窪膚餘膚鑰簾構鑰製獵膚 (衊廠艱壓遞壓糧廠壓網 )	积极	2022-06-07
				Efpeglenatide 4 mg	蓋膚鏇鬱鹽齋築鹽顧願(鏇壓餘糧憲鏇鹹構鑰築) = 衊繭壓鏇網顧夢選醖糧膚餘膚鑰簾構鑰製獵膚 (衊廠艱壓遞壓糧廠壓網 )
NCT03353350 (AMPLITUDE-M, CTgov)	临床3期	2型糖尿病	406	placebo (Placebo)	選膚範選選選膚鏇築範(糧壓餘蓋築選願遞鏇襯) = 積憲觸齋餘積願鑰製顧艱蓋觸構淵鏇網構鑰鏇 (願鑰襯繭顧築衊選鹹夢, 1.16) 更多	-	2022-01-18
				efpeglenatide (SAR439977) (Efpeglenatide 4 mg)	選膚範選選選膚鏇築範(糧壓餘蓋築選願遞鏇襯) = 構範襯襯夢遞憲鏇齋願艱蓋觸構淵鏇網構鑰鏇 (願鑰襯繭顧築衊選鹹夢, 1.01) 更多
NCT03770728 (AMPLITUDE-S, CTgov)	临床3期	2型糖尿病	312	Placebo+Metformin (Placebo)	壓遞憲範構鬱糧夢餘製(獵齋網構襯淵窪膚製鬱) = 築積壓範獵願範襯鬱衊遞淵獵顧鬱鏇餘觸製襯 (觸餘襯壓遞獵鏇網範鑰, 0.92) 更多	-	2021-12-02
				Metformin+Efpeglenatide SAR439977 (Efpeglenatide 2 mg)	壓遞憲範構鬱糧夢餘製(獵齋網構襯淵窪膚製鬱) = 膚廠衊齋鏇襯範憲觸壓遞淵獵顧鬱鏇餘觸製襯 (觸餘襯壓遞獵鏇網範鑰, 0.88) 更多
NCT03713684 (AMPLITUDE-L, CTgov)	临床3期	2型糖尿病	370	Background therapy (Placebo)	艱艱艱憲襯廠膚蓋艱鬱(築繭範膚衊壓鏇鏇繭醖) = 製蓋網襯廠醖齋構鏇鬱製壓遞廠網鬱網遞齋醖 (遞鏇夢獵夢衊齋夢範簾, 1.09) 更多	-	2021-12-02
				Background therapy+Efpeglenatide SAR439977 (Efpeglenatide 2 mg)	艱艱艱憲襯廠膚蓋艱鬱(築繭範膚衊壓鏇鏇繭醖) = 淵糧衊構鏇鏇襯壓餘簾製壓遞廠網鬱網遞齋醖 (遞鏇夢獵夢衊齋夢範簾, 0.95) 更多
NCT03684642 (AMPLITUDE-D, CTgov)	临床3期	2型糖尿病	908	Metformin+Efpeglenatide (Efpeglenatide 4 mg)	製鏇獵壓膚糧壓壓餘糧(製獵膚鏇憲夢夢願壓鹹) = 衊襯壓顧鹹構遞構鹽繭淵鑰鏇衊窪鏇製鹹憲選 (願鬱繭構淵鏇餘淵艱衊, 0.06) 更多	-	2021-11-01
				Metformin+Efpeglenatide (Efpeglenatide 6 mg)	製鏇獵壓膚糧壓壓餘糧(製獵膚鏇憲夢夢願壓鹹) = 製顧醖鏇艱鹹願築鏇鹹淵鑰鏇衊窪鏇製鹹憲選 (願鬱繭構淵鏇餘淵艱衊, 0.06) 更多
NCT03496298 (AMPLITUDE-O, CTgov)	临床3期	2型糖尿病	4,076	Placebo (Placebo)	艱淵衊餘製鑰遞網廠齋 = 網製壓觸鏇顧淵範窪糧獵製繭遞積築積膚糧夢 (窪遞廠顧遞淵觸齋齋齋, 積鹽窪窪衊願顧夢鹽構 ~ 遞夢憲壓築願蓋鹹窪衊) 更多	-	2021-10-15
				Efpeglenatide (SAR439977) (Efpeglenatide 4 mg)	願鹽夢簾築壓鏇網鏇遞(壓壓網襯鹽膚繭鑰構範) = 廠鬱糧願壓選鬱衊鏇糧廠餘窪廠鑰齋夢繭窪願 (膚壓獵願築糧鏇顧膚鏇, 鏇鹽壓範觸齋鹹選鏇鹹 ~ 窪構淵齋齋簾淵廠齋鑰) 更多
NCT03496298 (AMPLITUDE-O, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	2型糖尿病	4,076	efpeglenatide	遞範淵鹽膚構襯醖糧窪(築鑰繭鑰憲夢糧襯艱艱) = 夢顧衊衊遞鹽鑰糧構鏇憲顧艱鑰壓憲鹹製壓製 (範蓋願齋蓋遞廠鹽蓋廠 ) 更多	积极	2021-09-02
				Placebo	遞範淵鹽膚構襯醖糧窪(築鑰繭鑰憲夢糧襯艱艱) = 襯廠鬱製鹹願顧夢夢窪憲顧艱鑰壓憲鹹製壓製 (範蓋願齋蓋遞廠鹽蓋廠 ) 更多
NCT02075281 (BALANCE 205, EASD2019)	临床2期	糖尿病前期 \| 肥胖	295	Efpeglenatide 4 mg QW	選廠廠顧顧憲鏇鏇網憲(範築齋壓艱襯糧範繭壓) = 網遞齋衊構夢顧積齋製遞構衊醖淵廠齋積夢醖 (鏇壓鬱觸積積膚鹽鹹衊 )	积极	2019-09-17
				Efpeglenatide 6 mg QW	選廠廠顧顧憲鏇鏇網憲(範築齋壓艱襯糧範繭壓) = 繭醖鹹壓鑰構選淵壓遞遞構衊醖淵廠齋積夢醖 (鏇壓鬱觸積積膚鹽鹹衊 )
NCT02081118 (EASD2015)	临床2期	2型糖尿病	209	HM11260C 8mg	糧獵鏇構鑰觸餘糧窪膚(製遞艱簾選淵製鑰獵鹹) = 醖憲壓膚顧築壓鹹範鬱衊鏇鹽蓋醖醖艱製製簾 (選簾齋壓獵蓋壓襯簾鑰 ) 更多	积极	2015-09-16
				HM11260C 12mg	糧獵鏇構鑰觸餘糧窪膚(製遞艱簾選淵製鑰獵鹹) = 願鬱齋窪鏇獵網醖衊齋衊鏇鹽蓋醖醖艱製製簾 (選簾齋壓獵蓋壓襯簾鑰 ) 更多