CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 267 enrolled
Drug / intervention
Leu Sil 1.0mg +4 moredrug
Likely dose
Leu Sil 1.0mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03364335
NCT03364335Phase 2Completed
CompareCT.gov

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

NuSirt Biopharma·interventional·Posted Dec 6, 2017·Updated Aug 21, 2019

In Brief

A Phase 2 clinical trial evaluating Leu Sil 1.0mg, Leu Sil 4.0mg, and 3 other interventions for Obesity. Completed, enrolled 267 participants across 15 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 6, 2017
Enrollment StartJan 8, 2018
Primary CompletionAug 6, 2018
Study CompletionAug 17, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.6 years ago

Interventions

Leu Sil 1.0mgdrug

Leu 1100 mg + 1mg Sil BID

Leu Sil 4.0mgdrug

Leu 1100 mg + 4mg Sil BID

Leu Met Sil 1.0mgdrug

Leu 1100 mg + Met 500mg + 1mg Sil BID

Leu Met Sil 4.0mgdrug

Leu 1100 mg + Met 500mg + 4mg Sil BID

Placebodrug

Placebo