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

Phase 2

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: HD-6277 100mg; Drug: HD-6277 50mg; Drug: HD-6277 25mg; Drug: Placebo

• Registration Number: NCT06647550
• Lead Sponsor: Hyundai Pharm

Brief 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

Detailed Description

This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise.

This is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.

Study Timeline

• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-18
• Status Verified: 2024-12
• Study Start: 2024-12-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-03-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 8 weeks prior to screening.

Exclusion Criteria

• Type 1 diabetes or another immune-mediated diabetes syndrome
• BMI: > 40 kg/m2
• C-peptide: < 0.5ng/mL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HD-6277 100mg tab	HD-6277 100mg	Oral tablet
HD-6277 50mg tab	HD-6277 50mg	Oral tablet
HD-6277 25mg tab	HD-6277 25mg	Oral tablet
Placebo	Placebo	Oral tablet

Primary Outcome Measures

Name	Time	Method
change in HbA1c at weeks 12 from baseline	at weeks 12 from baseline	change in HbA1c at weeks 12 from baseline

Secondary Outcome Measures

Name	Time	Method
change in HbA1c at weeks 6 from baseline	at weeks 6 from baseline	change in HbA1c at weeks 6 from baseline
percentage of subjects with HbA1c level below 7.0% at weeks 12	at weeks 12	percentage of subjects with HbA1c level below 7.0% at weeks 12
percentage of subjects with HbA1c level below 6.5% at weeks 12	at weeks 12	percentage of subjects with HbA1c level below 6.5% at weeks 12
change in Glycoalbumin at weeks 6 and 12 from baseline	at weeks 6 and 12 from baseline	change in Glycoalbumin at weeks 6 and 12 from baseline

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of