2026年9月29日,礼来公司公布了新的3期临床试验结果,雷他鲁肽(Retatrutide)的副作用再次成为关注焦点。雷他鲁肽是一种尚在研究阶段的每周一次注射剂,目前尚未获得FDA批准,因此以下所有内容均来自临床试验,而非日常处方实践。本文将介绍试验中关于恶心、腹泻、皮肤异常感觉及停药情况的报告,以及医生通常用于监测此类药物使用者的血液检查项目。.
本文旨在帮助您平静地理解这些数据。临床试验结果描述的是在严密监督下参与试验的志愿者群体,无法预测您个人的具体情况。.
雷他鲁肽是什么,目前进展如何
雷他鲁肽可同时激活三种激素受体:GLP-1、GIP和胰高血糖素。司美格鲁肽仅作用于其中一种,替尔泊肽作用于两种,因此雷他鲁肽常被称为三重激动剂。在TRIUMPH项目中,患有肥胖症或超重(无论是否合并2型糖尿病)的成年人接受每周一次注射或安慰剂治疗,疗程约为80周。.
礼来公司最新公告显示,计划于2027年初向FDA提交申请。在监管机构批准之前,雷他鲁肽不可凭处方获取。.
3期临床试验中报告的雷他鲁肽副作用
消化系统反应最为常见
TRIUMPH-1试验共纳入2,339名无糖尿病的成年人,在12 mg剂量下,胃肠道症状是最常见的不良反应。以下是根据礼来公司试验结果的公开报道,与安慰剂组的对比汇总。.
| 副作用(TRIUMPH-1,12 mg) | 雷他鲁肽组 | 安慰剂组 |
|---|---|---|
| 恶心 | 42.4% | 14.8% |
| 腹泻 | 32.0% | 13.5% |
| 便秘 | 26.1% | 10.9% |
| 呕吐 | 25.3% | 4.8% |
上述不良事件被描述为轻度至中度。此前发表于《新英格兰医学杂志》的2期临床试验发现,这些反应与剂量相关,采用较低起始剂量可在一定程度上减轻症状。.
感觉异常:一个新出现的信号
感觉异常(Dysesthesia)是指皮肤出现异常或不适的感觉,如刺痛、灼热感或触觉过敏。这一现象在早期2期试验中未见报告。据BioSpace报道,在针对肥胖合并膝关节骨关节炎患者的TRIUMPH-4试验中,9 mg组有8.8%的受试者出现该症状,12 mg组为20.9%,而安慰剂组仅为0.7%。在TRIUMPH-1试验中,该症状被描述为轻度。礼来公司报告称,这些不良事件并未导致受试者停止治疗。.
停药情况
在TRIUMPH-1试验中,因副作用而停药的比例:4 mg组为4.1%,9 mg组为6.9%,12 mg组为11.3%,安慰剂组为4.9%。在TRIUMPH-4试验中,停药比例更高:9 mg组为12.2%,12 mg组为18.2%,安慰剂组为4%。礼来公司将此部分归因于参与者认为自身体重下降过多。.
TRIUMPH-2新结果的意义
TRIUMPH-2试验对1,152名患有2型糖尿病且合并肥胖或超重的成年人进行了为期80周的随访。在12 mg剂量下,平均体重减轻20.8%,而安慰剂组为4.0%;两个较高剂量组的糖化血红蛋白(A1C)下降约1.5至1.6个百分点,安慰剂组仅下降0.2个百分点。消化道反应仍是主要问题,12 mg组中腹泻发生率为33.6%,恶心发生率为28.0%,而安慰剂组分别为13.2%和8.0%。因副作用停药率为7.7%,安慰剂组为4.9%。.
有两点需要注意。上述数据来源于公司新闻稿,完整的同行评审论文尚未发表。此外,糖尿病患者的研究结果往往与非糖尿病患者有所不同。.
医生在GLP-1类药物治疗期间可能会开具的血液检查
目前没有任何血液检查能预测瑞他鲁肽是否适合您。下表列出了医生在使用GLP-1类药物或针对相关疾病时常用的检查项目。这仅反映一般临床实践和常识,并非瑞他鲁肽试验制定的监测方案,具体需要做哪些检查由您的主治医生决定。.
| 测试 | 为何可能开具此项检查 | 注意事项 |
|---|---|---|
| 糖化血红蛋白(HbA1c)与空腹血糖 | 追踪数周至数月内的血糖变化 | 试验显示2型糖尿病患者的A1C明显下降,其他降糖药物可能需要重新评估。. |
| 血脂检测 | 了解体重减轻对胆固醇和甘油三酯的影响 | 试验报告显示非HDL胆固醇和甘油三酯有所改善。. |
| ALT 和 AST | 检查肝酶,肝酶在脂肪肝病变中常见升高 | 我们查阅的公开摘要未详细说明肝酶的变化情况。. |
| 肌酐、eGFR及电解质 | 排查呕吐或腹泻后引起的脱水 | 如消化道症状持续存在,建议进行检查。. |
| 脂肪酶 | 排查严重且持续的上腹部疼痛 | 这不是常规筛查项目,单次结果不能单独诊断胰腺炎。. |
如需了解血糖控制的检测方式,请阅读我们的指南: 糖化血红蛋白(HbA1c)检测. 。肝酶的相关说明请参阅 我们关于ALT水平及其原因的指南, ,您可在就诊前提前阅读。许多实验室报告中会包含 eGFR值 用于评估肾脏过滤功能,您也可以阅读 我们关于淀粉酶和脂肪酶的解读文章 了解胰腺相关内容。如需深入了解胆固醇,请参阅 高级血脂检测.
最新科学进展
2023年发表于《新英格兰医学杂志》的首项大型2期临床试验显示,瑞他鲁肽能使肥胖成人实现显著的体重减轻,且消化道不良反应与剂量相关。研究还发现,心率会随剂量升高而加快,但随后会有所缓解。这对您意味着什么:从较低剂量开始可能更易耐受,您的医生可能会同时监测您的脉搏和血液检查结果。.
2026年发表的一项系统综述与荟萃分析汇总了早期随机试验的数据。结果显示,因不良反应而停止治疗的患者比例高于安慰剂组,但严重不良事件并不常见。研究者强调,由于可纳入的试验数量有限,且3期数据尚未完整发表,现有证据仍较为有限。这对您意味着什么:该药物的前景值得期待,但长期数据尚不完整,因此任何用药决定都应在监管机构批准的前提下,由您的医生来指导。.
为何使用未经批准的瑞他鲁肽风险更高
Because demand is high, products sold online as retatrutide or as a research peptide are widespread. The FDA warns that unapproved versions of GLP-1 drugs are not reviewed for safety, effectiveness or quality, and it had received more than 1,700 adverse event reports about compounded GLP-1 products as of May 2026. Trial results cannot be applied to a vial of unknown content and strength. If you already use such a product and feel unwell, tell a clinician what you took.
何时应该去看医生
Contact a doctor promptly if you have vomiting or diarrhea that will not stop, signs of dehydration such as dizziness or very dark urine, or severe pain in the upper abdomen that spreads to the back. Seek urgent care for a swollen face, trouble breathing, or chest pain. New burning, tingling or pain in the skin also deserves a conversation, especially if it lasts.
词汇表
- Triple agonist: a drug that switches on three hormone receptors, here GLP-1, GIP and glucagon.
- Dysesthesia: an unpleasant or abnormal sensation of touch, such as burning or tingling.
- 糖化血红蛋白: a blood test that reflects average blood sugar over roughly three months.
- 安慰剂组: an inactive injection used for comparison in a trial.
- Phase 3 trial: a large late-stage study that tests whether a treatment works and is safe enough.
常见问题解答
Is retatrutide FDA approved?
No. It is investigational, and Lilly has said it plans to apply to the FDA. Until a decision is made, it cannot be prescribed in the United States.
What are the most common retatrutide side effects?
Nausea, diarrhea, constipation and vomiting were the most frequent in the phase 3 trials, usually mild to moderate. Decreased appetite also appeared in the diabetes trial.
What is the tingling or burning side effect?
It is called dysesthesia. It was more common at 12 mg than at 9 mg in TRIUMPH-4 and was described as mild in TRIUMPH-1.
Which blood tests are useful during treatment with this kind of drug?
Your doctor may check HbA1c, lipids, liver enzymes and kidney function, and may order lipase only if severe abdominal pain appears. The right set depends on your health history.
Is research-grade retatrutide sold online safe?
The FDA states that unapproved GLP-1 products are not checked for safety, effectiveness or quality. Trial data do not apply to them.
来源
- FDA: FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
- NIDDK (NIH): Prescription Medications to Treat Overweight and Obesity
- Eli Lilly: retatrutide TRIUMPH-2 results, September 29, 2026
- AJMC: Retatrutide in the phase 3 TRIUMPH-1 trial
- Pharmacy Times: Retatrutide in the pivotal phase 3 TRIUMPH-1 trial
- BioSpace: Retatrutide TRIUMPH-4 results and the dysesthesia safety signal
- Jastreboff et al., New England Journal of Medicine, 2023: triple-hormone-receptor agonist retatrutide for obesity, phase 2 trial
- Efficacy and safety of high-dose retatrutide in adults with obesity and type 2 diabetes: systematic review and Bayesian meta-analysis (SN Comprehensive Clinical Medicine, 2026)
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