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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

Study 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 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in HbA1c between active treatment groups and placebo at Week 12
Secondary outcome measures
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 more

Trial 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Add-on Study of MLR-1023 in Adults With Uncontrolled Type 2 Diabetes on Metformin Therapy
2017. "An Add-on Study of MLR-1023 in Adults With Uncontrolled Type 2 Diabetes on Metformin Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03279263.
All > Type 2 Diabetes
~52 spots leftby May 2025
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