Clinical trial

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

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT07205900

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObese, Obesity

Full registry 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 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.

Treatments and study arms

HM15275

Drug

HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.

Placebo of HM15275

Drug

A sterile, matching solution supplied in pre-filled syringes.

Primary outcomes

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.

Study locations

14 locations were listed when this page was built. The first 40 are shown.

Accellacare of McFarland🇺🇸 Ames, Iowa, United States
Texas Clinical Research Institute🇺🇸 Arlington, Texas, United States
Accellacare of Bristol-PAC of Tennessee🇺🇸 Bristol, Tennessee, United States
Bristol-Internal Medicine and Pediatric Associates of Bristol, P.C.🇺🇸 Bristol, Tennessee, United States
Accellacare of Cary - Cary Medical Group🇺🇸 Cary, North Carolina, United States
ProSciento Inc🇺🇸 Chula Vista, California, United States
Velocity Clinical Research, Dallas🇺🇸 Dallas, Texas, United States
Accellacare of Hickory🇺🇸 Hickory, North Carolina, United States
Accellacare of Charleston🇺🇸 Mt. Pleasant, South Carolina, United States
Accellacare of Duly - Duly Oak Lawn🇺🇸 Oak Lawn, Illinois, United States
Raleigh Medical Group, P.A.🇺🇸 Raleigh, North Carolina, United States
Accellacare of Piedmont - Piedmont HealthCare🇺🇸 Statesville, North Carolina, United States
Accellacare of Wilmington, LLC🇺🇸 Wilmington, North Carolina, United States
Accellacare of Winston Salem🇺🇸 Winston-Salem, North Carolina, United States