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<p>To evaluate the efficacy and safety of NH600001, a novel etomidate derivative, in gastrointestinal endoscopy, as well as its impact on adrenocortical function, two multicenter, double-blind, randomized, controlled clinical trials(NH600001-21 [Phase II trial] and NH600001-31 [Phase III trial]) were conducted in China. In NH600001-21, 160 gastroscopy subjects were randomized 1:1:1:1 to receive NH600001 (0.20, 0.25, or 0.30 mg/kg) and etomidate (0.30 mg/kg). In NH600001-31, 344 gastroscopy or colonoscopy subjects were randomized in a 1:1 ratio to receive NH600001 (0.25 mg/kg) and etomidate (0.30 mg/kg). The primary efficacy outcome was the rate of endoscopic success. Additionally, Safety and effects on adrenocortical function were also assessed. In NH600001-21, the 0.25 mg/kg NH600001 showed non-inferiority to etomidate based on the prespecified non-inferiority margin of −8% (Rate Difference [95% confidence interval], 5.0[−4.49 to 14.49]), whereas the 0.20 mg/kg and 0.30 mg/kg NH600001 did not meet statistical non-inferiority criteria (0[−11.54 to 11.54]; 0[−11.54 to 11.54]). The area under curve (AUC) of plasma cortisol change values within 0-4 h (∆Cortisol AUC<sub>0-4h</sub>) were significantly higher in the NH600001 treatment groups than in the etomidate group (<i>P</i> &lt; 0.01). In NH600001-31, NH600001 (0.25 mg/kg) showed non-inferiority to etomidate (1.16[−0.44 to 2.76]). ∆Cortisol AUC<sub>0-4h</sub> in the NH600001 group, versus the etomidate group, were significantly higher (<i>P</i> &lt; 0.001). Furthermore, NH600001 had a safety profile comparable to etomidate and elicited fewer myoclonus adverse events. In Conclusions, NH600001 has a sedative/anesthetic effect comparable to etomidate while reducing the risk of adrenocortical depression with a favorable safety profile. <a href="https://www.chictr.org.cn">Chictr.org.cn</a> identifier: ChiCTR2300069841, ChiCTR2400084095. Clinical Trial Number and Registry URL: NH60001-21, Identifier, ChiCTR2300069841 (Changsha, China;, principal investigator: Wen Ouyang, first registration date: March 28, 2023), <a href="https://www.chictr.org.cn/showproj.html?proj=178745">https://www.chictr.org.cn</a>; NH60001-31, Identifier, ChiCTR2400084095 (Changsha, China, principal investigator: Wen Ouyang, first registration date: May 10, 2024), <a href="https://www.chictr.org.cn/showproj.html?proj=229972">https://www.chictr.org.cn</a>.</p>

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NH600001, an etomidate analogue, provides gastrointestinal endoscopy sedation/anesthesia and reduces adrenocortical depression: two randomized controlled trials

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  • 发表日期：

    2026年5月4日

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  • Yingyong Zhou,
  • Kaiming Duan,
  • Shichao Luo,
  • Shengping Liu,
  • Qiongcan Li,
  • Songhua Liu,
  • Huajing Guo,
  • Haitao Jiang,
  • Guyan Wang,
  • Huijun Wang,
  • Zhiping Wang,
  • Xiaobao Zhang,
  • Canlin Sun,
  • Qiang Wang,
  • Wei Gao,
  • Wangning Shangguan,
  • Zhongyuan Xia,
  • Ailin Luo,
  • Chun Chen,
  • Mengchang Yang,
  • Wenjie Su,
  • Xiaohua Zou,
  • Yalan Li,
  • Hao Wang,
  • Yanjuan Huang,
  • Ruping Dai,
  • Qian Zhao,
  • Shuan Jing,
  • Linzhong Zhang,
  • Wenjun Yan,
  • Xingang Qin,
  • Juan Wang,
  • Jingli Chen,
  • Jun Cao,
  • Minsheng Zhang,
  • Shuchun Yu,
  • Wen Ouyang,
  • Saiying Wang

摘要

To evaluate the efficacy and safety of NH600001, a novel etomidate derivative, in gastrointestinal endoscopy, as well as its impact on adrenocortical function, two multicenter, double-blind, randomized, controlled clinical trials(NH600001-21 [Phase II trial] and NH600001-31 [Phase III trial]) were conducted in China. In NH600001-21, 160 gastroscopy subjects were randomized 1:1:1:1 to receive NH600001 (0.20, 0.25, or 0.30 mg/kg) and etomidate (0.30 mg/kg). In NH600001-31, 344 gastroscopy or colonoscopy subjects were randomized in a 1:1 ratio to receive NH600001 (0.25 mg/kg) and etomidate (0.30 mg/kg). The primary efficacy outcome was the rate of endoscopic success. Additionally, Safety and effects on adrenocortical function were also assessed. In NH600001-21, the 0.25 mg/kg NH600001 showed non-inferiority to etomidate based on the prespecified non-inferiority margin of −8% (Rate Difference [95% confidence interval], 5.0[−4.49 to 14.49]), whereas the 0.20 mg/kg and 0.30 mg/kg NH600001 did not meet statistical non-inferiority criteria (0[−11.54 to 11.54]; 0[−11.54 to 11.54]). The area under curve (AUC) of plasma cortisol change values within 0-4 h (∆Cortisol AUC0-4h) were significantly higher in the NH600001 treatment groups than in the etomidate group (P < 0.01). In NH600001-31, NH600001 (0.25 mg/kg) showed non-inferiority to etomidate (1.16[−0.44 to 2.76]). ∆Cortisol AUC0-4h in the NH600001 group, versus the etomidate group, were significantly higher (P < 0.001). Furthermore, NH600001 had a safety profile comparable to etomidate and elicited fewer myoclonus adverse events. In Conclusions, NH600001 has a sedative/anesthetic effect comparable to etomidate while reducing the risk of adrenocortical depression with a favorable safety profile. Chictr.org.cn identifier: ChiCTR2300069841, ChiCTR2400084095. Clinical Trial Number and Registry URL: NH60001-21, Identifier, ChiCTR2300069841 (Changsha, China;, principal investigator: Wen Ouyang, first registration date: March 28, 2023), https://www.chictr.org.cn; NH60001-31, Identifier, ChiCTR2400084095 (Changsha, China, principal investigator: Wen Ouyang, first registration date: May 10, 2024), https://www.chictr.org.cn.