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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    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