Status:
RECRUITING
Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Obese
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
HM-OBCT-201 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel group study designed to evaluate the efficacy, safety, and tolerability of HM15275 treatment over 36 weeks...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Participant's age at the time of signing the informed consent:
- United States: 18 to 75 years (inclusive)
- Korea: 19 to 75 years (inclusive)
- BMI ≥30 kg/m² and ≤50 kg/m², or ≥27 kg/m² and \<30 kg/m² with ≥1 weight-related comorbidity
- Body weight change \<5% over the past 3 months prior to screening
- Capable of giving signed informed consent, ability and willingness to comply with all protocol procedures
- Key Exclusion Criteria:
- Type 1 diabetes mellitus or T2DM, or HbA1c ≥6.5% / FPG ≥126 mg/dL
- Obesity due to endocrine/genetic disorders
- Planned or prior obesity surgery (unless \>1 year ago for liposuction/abdominoplasty), or device-based obesity therapy (unless removed \>6 months ago)
- 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.
- 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.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
December 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT07205900
Start Date
December 2 2025
End Date
January 1 2027
Last Update
December 11 2025
Active Locations (13)
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1
ProSciento Inc
Chula Vista, California, United States, 91911
2
Accellacare of Duly - Duly Oak Lawn
Oak Lawn, Illinois, United States, 60453
3
Accellacare of McFarland
Ames, Iowa, United States, 50010
4
Accellacare of Cary - Cary Medical Group
Cary, North Carolina, United States, 27511