NCT03364335

The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: NuSirt Biopharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a randomized, 24-week, placebo-controlled, double-blind 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. Subjects meeting all the inclusion criteria and no exclusion criteria will be randomized to one of five study arms. 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) receiving two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Secondary objectives will also assess changes in absolute body weight, percentage of patients with ≥5% body weight loss, change in waist circumference, change in HbA1c, change in fasting glucose, change in blood lipids such as cholesterol, LDL, HDL, triglycerides, change in blood pressure and changes in in C-reactive protein. In addition this study will evaluate the safety and tolerability of NS-0200 and NS-0300. Patients will have one screening visits which will determine their eligibility based on lab tests. Once qualified, patients will be randomly assigned to either one of the treatment groups or the placebo control group and monitored for a total of 24 weeks. Patients will return to the clinic each month for lab tests, and routine examinations.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Leu Sil 1.0mg	Leu 1100 mg + 1mg Sil BID
DRUG	Leu Sil 4.0mg	Leu 1100 mg + 4mg Sil BID
DRUG	Leu Met Sil 1.0mg	Leu 1100 mg + Met 500mg + 1mg Sil BID
DRUG	Leu Met Sil 4.0mg	Leu 1100 mg + Met 500mg + 4mg Sil BID
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-01-08
• Primary completion: 2018-08-06
• Completion: 2018-08-17
• First posted: 2017-12-06
• Last updated: 2019-08-21
• Results posted: 2018-11-27

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study