RecruitingPhase 2NCT06647550

To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise


Sponsor

Hyundai Pharm

Enrollment

160 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise


Eligibility

Min Age: 19 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and effectiveness of a new drug called HD-6277 in adults with type 2 diabetes whose blood sugar is not adequately controlled by diet and exercise alone. **You may be eligible if...** - You have been diagnosed with type 2 diabetes - Your HbA1c (a measure of average blood sugar over 3 months) is between 7.0% and 10.0% - You have been managing your diabetes with diet and exercise only (no medication) for at least 8 weeks before the study **You may NOT be eligible if...** - You have type 1 diabetes or another immune-related form of diabetes - Your BMI is above 40 kg/m² - Your C-peptide level (a marker of insulin production) is very low (below 0.5 ng/mL) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHD-6277 100mg

PO, QD

DRUGHD-6277 50mg

PO, QD

DRUGHD-6277 25mg

PO, QD

DRUGPlacebo

PO, QD


Locations(1)

Korea University Anam Hospital

Seoul, South Korea

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NCT06647550


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