A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Subjects With Type 2 Diabetes Mellitus
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Participant's age at the time of signing the informed consent:
⁃ United States: 18 to 75 years (inclusive)
• Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
• Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
• BMI ≥25 kg/m² and ≤50 kg/m²
• Body weight change \<5% over the past 3 months prior to screening
• Capable of giving signed informed consent and willing to comply with all protocol procedures
Locations
United States
Arizona
Lenzmeier Family Medicine
RECRUITING
Glendale
Desert Clinical Research
RECRUITING
Mesa
Florida
AdventHealth Translational Research Institute
NOT_YET_RECRUITING
Orlando
Indiana
The South Bend Clinic
RECRUITING
South Bend
Missouri
Jefferson City Medical Center
RECRUITING
Jefferson City
Clay Platte Family Medicine
RECRUITING
Kansas City
North Carolina
Lucas Research, Inc.
NOT_YET_RECRUITING
Morehead City
Nebraska
Methodist Physicians Clinic
NOT_YET_RECRUITING
Fremont
Nevada
Santa Rosa Medical Centers of Nevada
RECRUITING
Las Vegas
Utah
Olympus Family Medicine
RECRUITING
Salt Lake City
Contact Information
Primary
Pureun Nam
pureun.nam@hanmi.co.kr
+82-2-410-9147
Backup
Hyeonho Choi
hyeonho.choi@hanmi.co.kr
+82-2-410-9834
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2027-10
Participants
Target number of participants: 180
Treatments
Experimental: HM15275
Participants will receive HM15275 via subcutaneous (SC) injection.
Placebo_comparator: Placebo of HM15275
Participants will receive placebo of HM15275 via subcutaneous (SC) injection.
Related Therapeutic Areas
Sponsors
Leads: Hanmi Pharmaceutical Company Limited