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).

Start Date08 Jan 2018

Sponsor / Collaborator

NuSirt Biopharma, Inc.

NCT02546609

/ CompletedPhase 2

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.

Start Date19 Nov 2015

Sponsor / Collaborator

NuSirt Biopharma, Inc.

100 Clinical Results associated with Sildenafil/Metformin/Leucine

100 Translational Medicine associated with Sildenafil/Metformin/Leucine

100 Patents (Medical) associated with Sildenafil/Metformin/Leucine

Literatures (Medical) associated with Sildenafil/Metformin/Leucine

01 Jan 2019·Obesity

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

Article

Author: 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 Deals associated with Sildenafil/Metformin/Leucine

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	-	Nusirt Sciences, Inc.	-
Obesity	Preclinical	United States	NuSirt Biopharma, Inc.	08 Jan 2018
Metabolic dysfunction-associated steatotic liver disease	Preclinical	United States	NuSirt Biopharma, Inc.	19 Nov 2015
Nonalcoholic Steatohepatitis	Preclinical	United States	Nusirt Sciences, Inc.	19 Nov 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02546609 (Pubmed)	Phase 2	Metabolic dysfunction-associated steatotic liver disease	91	Placebo	uuinqsrogu(cwrqjhvbpt) = cnjfngaiyt ucumsxegao (hwmgjfxpge )	-	01 Jan 2019
				High dose (1.1 g leucine/0.5 g metformin/1.0 mg sildenafil)	(xjdcdxwaew) = firudikwyx pcuewdtxlu (mnhtuptwkw ) View more
NCT03364335 (CTgov)	Phase 2	Obesity	267	Placebo (Placebo)	hrxxtnziht(pvtibrfczb) = mcvclvmlih yfaroyvkck (dbiexbvytn, enwtyvfzss - uyzftjxbsk) View more	-	27 Nov 2018
				Leu Sil 4.0mg (Leu Sil 1.0mg)	hrxxtnziht(pvtibrfczb) = iqmtbiiixc yfaroyvkck (dbiexbvytn, ainwedgirc - lpnvjiqtvi) View more
NCT02546609 (CTgov)	Phase 2	Metabolic dysfunction-associated steatotic liver disease	91	Placebo (Placebo)	wjflqipeev(rbmrxbjdgs) = iyyqbhvgdh vsqqsqwlqs (rjyoyggxch, mxmhpakwlv - gjazbjpkqv) View more	-	02 May 2018
				Leu-Met-Sil 1.0 (Leu Met Sil 0.5mg)	wjflqipeev(rbmrxbjdgs) = hdudawghgs vsqqsqwlqs (rjyoyggxch, nclpihvjtj - mhxdjqscbt) View more

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