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

Hanmi Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Obese; Obesity

Treatments: Drug: Placebo of HM15275; Drug: HM15275

Study type: Interventional

Funder types: Industry

Identifiers

NCT07205900

HM-OBCT-201

Details and patient eligibility

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups, including a placebo group

HM15275

Experimental group

Description:

Participants will receive HM15275 via subcutaneous (SC) injection.

Treatment:

Drug: HM15275

Placebo of HM15275

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo of HM15275