MedDataX Logo

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

NCT ID: NCT06647550

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus (T2DM)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HD-6277 100mg tab

Oral tablet

Group Type EXPERIMENTAL

HD-6277 100mg

Intervention Type DRUG

PO, QD

HD-6277 50mg tab

Oral tablet

Group Type EXPERIMENTAL

HD-6277 50mg

Intervention Type DRUG

PO, QD

HD-6277 25mg tab

Oral tablet

Group Type EXPERIMENTAL

HD-6277 25mg

Intervention Type DRUG

PO, QD

Placebo

Oral tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

PO, QD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HD-6277 100mg

PO, QD

Intervention Type DRUG

HD-6277 50mg

PO, QD

Intervention Type DRUG

HD-6277 25mg

PO, QD

Intervention Type DRUG

Placebo

PO, QD

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hyundai Pharm

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Korea University Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sin Gon Kim Korea University Anam Hospital, PhD

Role: CONTACT

Phone: +82 1577-0083

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sin-Gon Kim, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HT-006-04

Identifier Type: -

Identifier Source: org_study_id