Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus
NCT ID: NCT07205900
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
250 participants
INTERVENTIONAL
2025-12-02
2027-01-31
Brief Summary
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Detailed Description
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The study will enroll adult participants with obesity (body mass index \[BMI\] ≥30 kg/m2 and ≤50 kg/m2) or with overweight (BMI ≥27 kg/m2 and \<30 kg/m2) with at least 1 weight-related comorbidity. Patients with T2DM will be excluded.
Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms. Randomization will be stratified by sex (female vs male) and BMI (\<35 vs ≥35 kg/m2).
All participants will undergo a 6-week screening period, a 36-week treatment period (including the dose-titration phase with weekly subcutaneous \[SC\] injection), and a 4-week safety follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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HM15275
Participants will receive HM15275 via subcutaneous (SC) injection.
HM15275
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
Placebo of HM15275
Participants will receive placebo of HM15275 via subcutaneous (SC) injection.
Placebo of HM15275
A sterile, matching solution supplied in pre-filled syringes.
Interventions
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HM15275
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
Placebo of HM15275
A sterile, matching solution supplied in pre-filled syringes.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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ProSciento Inc
Chula Vista, California, United States
Accellacare of Duly - Duly Oak Lawn
Oak Lawn, Illinois, United States
Accellacare of McFarland
Ames, Iowa, United States
Accellacare of Cary - Cary Medical Group
Cary, North Carolina, United States
Accellacare of Hickory
Hickory, North Carolina, 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
Accellacare of Charleston
Mt. Pleasant, South Carolina, 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
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Elaine Watkins, MD
Role: primary
John Elsen, MD
Role: primary
Rupal Amin, MD
Role: primary
Sylvia Shoffner, MD
Role: primary
Robert Hart, MD
Role: primary
John Rubino, MD
Role: primary
Joseph Moran, MD
Role: primary
Kevin Dougherty Cannon, MD
Role: primary
Jonathan Wilson, DO
Role: primary
Alaina Payne, MD
Role: primary
Donald Quinn, MD
Role: primary
Bernard Grunstra, MD
Role: primary
Dan Lender, MD
Role: primary
Other Identifiers
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HM-OBCT-201
Identifier Type: -
Identifier Source: org_study_id
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