Clinical trials: sponsored by Hanmi Pharmaceutical Company Limited
Erectile Dysfunction
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
- Trial name
- NCT07899073
- Testing
- HIP2602 + HPP2602-2, HPP2602-1 + HPP2602-2, HGP1201 + HPP2602-1
- Where
- South Korea
- Volunteers
- 225 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Type 2 Diabetes Mellitus, T2DM
Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.
- Trial name
- NCT07527650
- Testing
- HM15275
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
NASH - Nonalcoholic Steatohepatitis
Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
- Trial name
- HM-TRIA-201 (NCT04505436)
- Testing
- HM15211
- Where
- 60 sites in United States, South Korea
- Volunteers
- 215 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Advanced or Metastatic Solid Tumors
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced…
- Trial name
- NCT06234397
- Testing
- BH3120, pembrolizumab
- Where
- 10 sites in United States, South Korea
- Volunteers
- 216 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Hypertension
A Study to Evaluate Efficacy and Safety of HGP2304 in Essential Hypertension Patients
A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HGP2304 in patients with essential hypertension
- Trial name
- NCT06174766
- Testing
- HGP2304-1, HGP2304-2, RLD2209-1
- Where
- South Korea
- Volunteers
- 356 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Congenital Hyperinsulinism
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC).
- Trial name
- NCT04732416
- Testing
- HM15136
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 17 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Hypertension
Effectiveness and Safety of Sequential Triple Combination Therapy (Amlodipine/Losartan/Chlorthalidone) in Korean Patients With Hypertension
A multicenter, prospective, non-interventional, observational study to evaluate effectiveness and safety of sequential triple combination therapy (amlodipine/losartan/chlorthalidone) in Korean patients with hypertension
- Trial name
- AMPR-OS-2503 (NCT07784296)
- Testing
- AMOPREL TAB 1.67/16.67/4.17mg
- Where
- South Korea
- Volunteers
- 3,500 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Short Bowel Syndrome
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal…
- Trial name
- NCT04775706
- Testing
- HM15912 Active
- Where
- 15 sites in United States, Belgium and 6 more
- Volunteers
- 18 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Advanced or Metastatic Solid Tumors
Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
This is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1/2 dual inhibitor, in solid tumors. The study is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part.
- Trial name
- NCT05598151
- Testing
- HM97662
- Where
- 10 sites in Australia, South Korea
- Volunteers
- 170 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Obesity
A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus
- Trial name
- NCT06174779
- Testing
- HM11260C
- Where
- South Korea
- Volunteers
- 448 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Hypertension
A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension
A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension
- Trial name
- NCT07660796
- Testing
- HCP1803-3, HCP1803-4, RLD2001-1
- Where
- South Korea
- Volunteers
- 256 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Type 2 Diabetes
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in patients with type 2 diabetes mellitus inadequately controlled with metformin and dapagliflozin
- Trial name
- NCT07379333
- Testing
- HM11260C
- Where
- South Korea
- Volunteers
- 118 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Obesity, Obese
A Single and Multiple Ascending Dose Study of HM17321 in Healthy and Obese Participants
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 after single and multiple ascending doses in healthy and obese participants.
- Trial name
- NCT07219589
- Testing
- HM17321
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Obese, Obesity
Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus
This Study is a Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Obese or Overweight Subjects Without Diabetes Mellitus.
- Trial name
- NCT07205900
- Testing
- HM15275
- Where
- 14 sites in United States
- Volunteers
- 267 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Advanced or Metastatic Melanoma
Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
This is a Phase 2 open-label, multicenter, single-arm study evaluating the combination of Belvarafenib and Cobimetinib in patients with locally advanced or metastatic melanoma with NRAS mutations.
- Trial name
- NCT07449754
- Testing
- Belvarafenib, Cobimetinib
- Where
- 10 sites in South Korea
- Volunteers
- 45 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Healthy
A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2503 and HCP1306 in healthy volunteers.
- Trial name
- NCT07297693
- Testing
- HIP2503, HCP1306
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Advanced or Metastatic Solid Tumors
Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced…
- Trial name
- NCT06724016
- Testing
- HM16390, pembrolizumab
- Where
- 7 sites in United States, South Korea
- Volunteers
- 292 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Chronic Low-back Pain
A Study to Evaluate the Efficacy and Safety of HCP1004 in Chronic Low-Back Pain Patients
A Randomized, Double-blind, Active-controlled, Non-inferiority, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HCP1004 as compared to RLD2401 in Chronic Low-Back Pain Patients
- Trial name
- LBP (NCT06595004)
- Testing
- HCP1004, RLD2401
- Where
- South Korea
- Volunteers
- 310 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Gastric Cancer
FLX475 Combined With Pembrolizumab in Patients With Advanced or Metastatic Gastric Cancer
This clinical study is a Phase 2, open-label study to assess the efficacy, safety profile of FLX475 combined with pembrolizumab in patients with advanced or metastatic gastric cancer.
- Trial name
- NCT04768686
- Testing
- FLX475, Pembrolizumab
- Where
- 10 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Obesity
A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects.
This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.
- Trial name
- NCT06481098
- Testing
- HM15275
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited