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

NCT03364335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2019-08-21

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • NuSirt Biopharma

    lead INDUSTRY

Principal Investigators

  • Michael B Zemel, PhD · NuSirt Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2018-08-06
Completion
2018-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03364335 on ClinicalTrials.gov