To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
HDNO-1605
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
1 other identifier
interventional
160
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 18, 2024
CompletedStudy Start
First participant enrolled
December 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedDecember 13, 2024
December 1, 2024
4 months
October 10, 2024
December 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
change in HbA1c at weeks 12 from baseline
change in HbA1c at weeks 12 from baseline
at weeks 12 from baseline
Secondary Outcomes (4)
change in HbA1c at weeks 6 from baseline
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 6.5% at weeks 12
at weeks 12
change in Glycoalbumin at weeks 6 and 12 from baseline
at weeks 6 and 12 from baseline
Other Outcomes (2)
change in body weight at weeks 6 and 12 from baseline
at weeks 6 and 12 from baseline
change in GA/HbA1c at weeks 6 and 12 from baseline
at weeks 6 and 12 from baseline
Study Arms (4)
HD-6277 100mg tab
EXPERIMENTALOral tablet
HD-6277 50mg tab
EXPERIMENTALOral tablet
HD-6277 25mg tab
EXPERIMENTALOral tablet
Placebo
PLACEBO COMPARATOROral tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Type 1 diabetes or another immune-mediated diabetes syndrome
- BMI: \> 40 kg/m2
- C-peptide: \< 0.5ng/mL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hyundai Pharmlead
Study Sites (1)
Korea University Anam Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2024
First Posted
October 18, 2024
Study Start
December 12, 2024
Primary Completion
March 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
December 13, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share