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MLR-1023 25mg QD for Type 2 Diabetes
Phase 2
Waitlist Available
Research Sponsored by Melior Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Summary
This Phase 2, multi-center, double-blind, randomized, placebo-controlled, parallel group, add-on study of MLR 1023 in adults with uncontrolled T2DM on metformin anti diabetic monotherapy is designed to evaluate the efficacy and safety of MLR 1023 in combination with metformin in subjects with uncontrolled T2DM.
Eligible Conditions
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in HbA1c between active treatment groups and placebo at Week 12
Secondary study objectives
Changes in Body Weight
Changes in Fasting Plasma Glucose (FPG) from Baseline to Week 12 between active treatment groups and placebo
Changes in fasting insulin, insulin sensitivities (HOMA IR)
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: MLR-1023 50mg QDExperimental Treatment1 Intervention
MLR-1023 50mg QD Tablet
Group II: MLR-1023 25mg QDExperimental Treatment1 Intervention
MLR-1023 25mg QD Tablet
Group III: MLR-1023 100mg QDExperimental Treatment1 Intervention
MLR-1023 100mg QD Tablet
Group IV: PlaceboPlacebo Group1 Intervention
Placebo QDTablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tolimidone
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Melior PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
149 Total Patients Enrolled
Bukwang Pharmaceutical, Co., Ltd.Industry Sponsor
3 Previous Clinical Trials
218 Total Patients Enrolled
Ramana Kuchibhatla, PhDStudy DirectorMelior Pharmaceuticals, Inc.
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