Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus

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

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.

Conditions3

Locations13 sites

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