Obese, Obesity
Conditions
Keywords
Obese, Obesity
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 in obese or overweight adults without Type 2 diabetes mellitus (T2DM). 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.
Interventions
DRUGHM15275
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
A sterile, matching solution supplied in pre-filled syringes.
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Treatment assignment will remain blinded to participants, investigators/study personnel, and sponsor's study team conducting the study. Participants who meet all criteria for enrollment will be centrally assigned randomized to study drug using an Interactive Web Response System (IWRS).
Intervention model description
Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 41 weeks | Number of participants with adverse events (AEs) after multiple subcutaneous (SC) doses. |
Countries
United States
Outcome results
None listed