HM15275: HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
Placebo of HM15275: A sterile, matching solution supplied in pre-filled syringes.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria
1. Participant's age at the time of signing the informed consent:
* United States: 18 to 75 years (inclusive)
* Korea: 19 to 75 years (inclusive)
2. BMI ≥30 kg/m² and ≤50 kg/m², or ≥27 kg/m² and \<30 kg/m² with ≥1 weight-related comorbidity
3. Body weight change \<5% over the past 3 months prior to screening
4. Capable of giving signed informed consent, ability and willingness to comply with all protocol procedures
Key Exclusion Criteria:
1. Type 1 diabetes mellitus or T2DM, or HbA1c ≥6.5% / FPG ≥126 mg/dL
2. Obesity due to endocrine/genetic disorders
3. Planned or prior obesity surgery (unless \>1 year ago for liposuction/abdominoplasty), or device-based obesity therapy (unless removed \>6 months ago)
4. Personal history or current diagnosis of acute or chronic pancreatitis or factors that may increase the risk of pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse.
5. Personal or family history of medullary thyroid carcinoma (MTC) or a known genetic condition (e.g., multiple endocrine neoplasia type 2) that predisposes the participant to MTC.
6. Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
7. History or current diagnosis of congestive heart failure (NYHA class Ⅲ or Ⅳ), or myocardial infarction, stroke, unstable angina, transient ischemic attack, or revascularization procedure (e.g., stent or bypass graft surgery) within 3 months prior to screening visit
8. Personal history or current diagnosis of acute or chronic pancreatitis or factors that may increase the risk of pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse.
Primary outcome measure(s)
Percent Change in Body Weight. — Up to 41 weeks Percent change in body weight from Week 1 to Week 37, measured using a standardized, calibrated scale under fasting conditions.
Trial sites (14)
Facility
City
Region
Status
ProSciento Inc
Chula Vista
California
Accellacare of Duly - Duly Oak Lawn
Oak Lawn
Illinois
Accellacare of McFarland
Ames
Iowa
Accellacare of Cary - Cary Medical Group
Cary
North Carolina
Accellacare of Hickory
Hickory
North Carolina
Raleigh Medical Group, P.A.
Raleigh
North Carolina
Accellacare of Piedmont - Piedmont HealthCare
Statesville
North Carolina
Accellacare of Wilmington, LLC
Wilmington
North Carolina
Accellacare of Winston Salem
Winston-Salem
North Carolina
Accellacare of Charleston
Mt. Pleasant
South Carolina
Accellacare of Bristol-PAC of Tennessee
Bristol
Tennessee
Bristol-Internal Medicine and Pediatric Associates of Bristol, P.C.
Bristol
Tennessee
Texas Clinical Research Institute
Arlington
Texas
Velocity Clinical Research, Dallas
Dallas
Texas
More Hanmi Pharmaceutical Company Limited trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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