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Recruiting Phase 2 NCT07205900

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

Trial Parameters

Condition Obese
Sponsor Hanmi Pharmaceutical Company Limited
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 250
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-12-02
Completion 2027-01
All Conditions
Interventions
HM15275Placebo of HM15275

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.

Eligibility Criteria

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 carci

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