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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
267
HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.
A sterile, matching solution supplied in pre-filled syringes.
ProSciento Inc
Chula Vista, California, United States
Accellacare of Duly - Duly Oak Lawn
Oak Lawn, Illinois, United States
Percent Change in Body Weight.
Percent change in body weight from Week 1 to Week 37, measured using a standardized, calibrated scale under fasting conditions.
Time frame: Up to 41 weeks
Number of participants with adverse events (AEs)
Number of participants with adverse events (AEs) after multiple subcutaneous (SC) doses.
Time frame: Up to 41 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 4 more locations