HD-6277 / Hyundai Pharm - LARVOL DELTA

HD6277 Suppresses Muscle Atrophy by Promoting Myogenic Factors and Inhibiting Proteolysis in Aged Mice. (PubMed, J Cachexia Sarcopenia Muscle) - "HD6277 can increase myogenic factors and reduce E3 ligase-mediated proteolysis to inhibit muscle atrophy in aged mice. Our results suggest that GPR40 agonists may have potential as therapeutic agents for sarcopenia."

IO biomarker • Journal • Preclinical • Inflammation • Muscular Atrophy • Obesity • Sarcopenia • Targeted Protein Degradation • BCL2 • CASP3 • FBXO32 • MEF2C • Myogenin

HDNO-1605: To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Hyundai Pharm | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise (clinicaltrials.gov) - P2 | N=112 | Completed | Sponsor: Hyundai Pharm | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

HDNO-1605: To Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Hyundai Pharm

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of HD-6277, a Novel GPR40 Agonist, in Patients with Type 2 Diabetes—A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Phase 2 Trial (ADA 2024) - P2 | "HD-6277 50mg and 100 mg improved glycaemic control in patients with T2DM inadequately controlled with diet and exercise, as shown by significant changes in HbA1c and FPG. The treatment with HD-6277 appeared to be safe and well tolerated. A GPR40 agonist represents a potential new treatment option for T2DM."

Clinical • P2 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CD36

Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise (clinicaltrials.gov) - P2 | N=113 | Recruiting | Sponsor: Hyundai Pharm

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

[VIRTUAL] A Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of HD-6277, a Potent and Selective G-Protein-Coupled Receptor 40 (GPR40) Agonist, in Patients with Type 2 Diabetes Mellitus (ADA 2020) - "The geometric mean accumulation ratio for AUC was 2.27 and 2.35 for the 25 and 100 mg dose levels, indicating modest accumulation of HD-6277 following multiple dose administration, which showed comparable profile with that of healthy subjects ranged from 2.14 to 2.34 across the dose levels in MAD study. Therefore, HD-6277 was safe, well tolerated and showed dose-related plasma exposure when the drug is administered at doses ranging from 25 to 100 mg in T2DM patients."

Clinical • P1 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetics, Pharmacodynamics, and Safety of HD-6277, a Selective Agonist of G-Protein-Coupled Receptor 40, in Healthy Subjects as a First-in-Human Study (ADA 2019) - "Therefore, this study showed HD-6277 was safe and well tolerated in healthy subjects. Its exploratory efficacy on type 2 diabetes mellitus patients is currently under evaluation."

Clinical • P1 data • PK/PD data