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

NCT07205900 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: HM-OBCT-201
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 14

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.

Conditions

Obese; Obesity

Keywords

Obese; Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 41 weeks

Secondary Outcomes (1)

• Number of participants with adverse events (AEs)

  Up to 41 weeks

Other Outcomes (1)

• Plasma concentration profile

  Up to 41 weeks

Study Arms (2)

HM15275

EXPERIMENTAL

Participants will receive HM15275 via subcutaneous (SC) injection.

Drug: HM15275

Placebo of HM15275

PLACEBO COMPARATOR

Participants will receive placebo of HM15275 via subcutaneous (SC) injection.

Drug: Placebo of HM15275

Interventions

Placebo of HM15275 DRUG

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

Placebo of HM15275

HM15275 DRUG

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

HM15275

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (14)

ProSciento Inc

Chula Vista, California, 91911, United States

Location

Accellacare of Duly - Duly Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Accellacare of McFarland

Ames, Iowa, 50010, United States

Location

Accellacare of Cary - Cary Medical Group

Cary, North Carolina, 27511, United States

Location

Accellacare of Hickory

Hickory, North Carolina, 28601, United States

Location

Raleigh Medical Group, P.A.

Raleigh, North Carolina, 27609, United States

Location

Accellacare of Piedmont - Piedmont HealthCare

Statesville, North Carolina, 28626, United States

Location

Accellacare of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Accellacare of Winston Salem

Winston-Salem, North Carolina, 27103, United States

Location

Accellacare of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Accellacare of Bristol-PAC of Tennessee

Bristol, Tennessee, 37620, United States

Location

Bristol-Internal Medicine and Pediatric Associates of Bristol, P.C.

Bristol, Tennessee, 37620, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in this study will be randomly assigned in a 1:1:1:1:1 ratio to 1 of the 5 treatment arms.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 3, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)