A Randomized, Double-blind, Placebo-controlled Study of Effects of Two Fixed-dose Leucine-sildenafil Combinations (NS-0300) or Two Fixed-dose Leucine-sildenafil-metformin Combinations (NS-0200) Versus Placebo on Body Weight in Obesity

This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24).

开始日期2018-01-08

申办/合作机构

NuSirt Biopharma, Inc.

NCT02546609

/ Completed临床2期

A Randomized, Blinded, Placebo-Controlled Study To Evaluate The Effect Fixed-Dose Leucine, Metformin, Sildenafil Combinations(NS-0200) Versus Placebo On Hepatic Fat Assessed By MRI In Non Alcoholic Fatty Liver Disease Patients

The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare two doses of NS-0200 to placebo in NAFLD patients.

开始日期2015-11-19

申办/合作机构

NuSirt Biopharma, Inc.

100 项与西地那非/二甲双胍/亮氨酸相关的临床结果

登录后查看更多信息

100 项与西地那非/二甲双胍/亮氨酸相关的转化医学

登录后查看更多信息

100 项与西地那非/二甲双胍/亮氨酸相关的专利（医药）

登录后查看更多信息

项与西地那非/二甲双胍/亮氨酸相关的文献（医药）

2019-01-01·Obesity

Randomized Controlled Trial of a Leucine‐Metformin‐Sildenafil Combination (NS‐0200) on Weight and Metabolic Parameters

Article

作者: Rinella, Mary ; Barritt, A. Sidney ; Chalasani, Naga ; Flores, Omar ; Kolterman, Orville ; Vuppalanchi, Raj ; Zemel, Michael B. ; Siddiqui, Mohammad

ObjectiveLeucine was previously demonstrated to allosterically activate mammalian sirtuin 1 and synergize with other sirtuin 1/AMP‐activated protein kinase/nitric oxide pathway activators to modulate energy metabolism. The objective of this study was to evaluate the effects of a triple combination of leucine, metformin, and sildenafil (NS‐0200) on body weight and obesity comorbidities in a phase 2 randomized trial.MethodsA total of 91 subjects with obesity were randomized to placebo, low dose (1.1 g leucine/0.5 g metformin/0.5 mg sildenafil), or high dose (1.1 g leucine/0.5 g metformin/1.0 mg sildenafil) twice daily for 16 weeks. Seventy subjects completed the trial and met all a priori compliance criteria. Hypertensive (n = 35) and hypertriglyceridemic (n = 22) subcohorts were also analyzed.ResultsNS‐0200 dose‐responsively reduced weight; high dose reduced weight by 2.4 and 5.0 kg in the full and high‐triglyceride cohorts, respectively (P < 0.0001). High‐dose NS‐0200 treatment also decreased blood pressure (−5.5 mm Hg diastolic pressure; P = 0.011), with greater effects among hypertensive subjects. NS‐0200 also significantly reduced triglycerides and hemoglobin A1c. Significant improvement in ≥ 2 comorbidities was exhibited by 54% of subjects in the high‐dose arm versus 5% of placebo subjects (P = 0.0009). Treatment‐emergent adverse events did not significantly differ among groups.ConclusionsThese data support further study of NS‐0200 as a therapy for obesity and associated comorbidities.

100 项与西地那非/二甲双胍/亮氨酸相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	临床2期	-	Nusirt Sciences, Inc.	-
肥胖	临床前	美国	NuSirt Biopharma, Inc.	2018-01-08
代谢功能障碍相关的脂肪肝病	临床前	美国	NuSirt Biopharma, Inc.	2015-11-19
非酒精性脂肪性肝炎	临床前	美国	Nusirt Sciences, Inc.	2015-11-19

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02546609 (Pubmed)	临床2期	代谢功能障碍相关的脂肪肝病	91	Placebo	襯願窪簾簾艱夢蓋遞廠(構衊鏇憲獵淵鏇鹽衊艱) = 築鑰壓遞範鹽網艱醖範餘構窪獵繭夢糧築醖鏇 (鑰衊淵顧淵範網積窪積 )	-	2019-01-01
				High dose (1.1 g leucine/0.5 g metformin/1.0 mg sildenafil)	(衊鹹鹽網鹽鏇鏇憲襯醖) = 憲膚選醖齋鏇廠衊衊選顧選窪遞糧鬱鏇製憲鏇 (簾製蓋蓋醖遞憲襯窪夢 ) 更多
NCT03364335 (CTgov)	临床2期	肥胖	267	Placebo (Placebo)	鬱糧觸鬱醖範艱襯簾顧(願製鬱網憲構餘築網蓋) = 選獵範獵艱網鏇鹽築鏇醖簾衊窪簾蓋膚簾鹹齋 (觸範淵鏇選襯選衊積鑰, 糧鹽艱築餘製築憲築範 ~ 鏇衊構廠鏇壓艱鹹願鹽) 更多	-	2018-11-27
				Leu Sil 4.0mg (Leu Sil 1.0mg)	鬱糧觸鬱醖範艱襯簾顧(願製鬱網憲構餘築網蓋) = 糧廠範齋鏇顧獵鹹淵鏇醖簾衊窪簾蓋膚簾鹹齋 (觸範淵鏇選襯選衊積鑰, 顧鬱鬱糧網艱淵窪鹹壓 ~ 獵遞壓憲淵憲築遞淵遞) 更多
NCT02546609 (CTgov)	临床2期	代谢功能障碍相关的脂肪肝病	91	Placebo (Placebo)	繭鑰襯壓膚糧構廠願淵(構築衊鹹餘膚鑰鏇壓鹽) = 窪鏇獵齋鹹鏇齋蓋鑰襯壓選蓋觸餘衊餘艱鹹衊 (製壓網製衊觸蓋製鏇鑰, 網鹽鹽醖夢網襯鑰遞網 ~ 顧膚遞簾鹽艱獵簾醖選) 更多	-	2018-05-02
				Leu-Met-Sil 1.0 (Leu Met Sil 0.5mg)	繭鑰襯壓膚糧構廠願淵(構築衊鹹餘膚鑰鏇壓鹽) = 憲鬱鬱壓糧膚糧顧醖齋壓選蓋觸餘衊餘艱鹹衊 (製壓網製衊觸蓋製鏇鑰, 廠淵顧鹽鹽齋壓壓夢衊 ~ 鑰壓願鏇夢鹽積憲鹹選) 更多