A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects.

Phase 1

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: HM15275; Drug: Placebo of HM15275

• Registration Number: NCT06481098
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-28
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-17
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Study Completion: 2025-09-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Female and male adults, ages ≥ 18 and ≤ 65 years.

2. Part A: Healthy subjects with body mass index (BMI) ≥ 20.0 kg/m2 and ≤ 27 kg/m2.

   Part B: Obese subjects with BMI ≥ 30.0 kg/m2 and ≤ 45.0 kg/m2 with a stable body weight for 3 months prior to screening (defined as change < 5%).

3. HbA1c < 6.5 % [based on American Diabetes Association, 2023].

4. Female subjects must be non-pregnant and non-lactating.

5. Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.

Exclusion Criteria

1. Subject with existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product.
2. Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for < 5 years.
3. Subjects with a history of any serious adverse reaction or hypersensitivity to study drug components (includes GLP-1, GIP, glucagon analogs) or have contraindicating diseases.
4. Subjects with confirmed type 1 or type 2 diabetes.
5. Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within from 24 hours before each study visit and while subjects are confined to the study center.
6. Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the Follow-up visit.
7. History of alcohol abuse as judged by the Investigator within approximately 1 year prior to Screening.
8. History of regular use (defined as ≥ 10 cigarettes per day) of nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipe, chewing tobacco, nicotine patch or gum) or vaping products within 6 weeks prior to check-in for the first In-house Period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HM15275	HM15275	Active comparator: Part A: single-ascending dose Single doses of HM15275 in healthy adults administered via subcutaneous injection. Part B: multiple-ascending dose Multiple doses of HM15275 in obese adults administered via subcutaneous injection.
HM15275	Placebo of HM15275	Active comparator: Part A: single-ascending dose Single doses of HM15275 in healthy adults administered via subcutaneous injection. Part B: multiple-ascending dose Multiple doses of HM15275 in obese adults administered via subcutaneous injection.
Placebo of HM15275	Placebo of HM15275	Placebo comparator: Part A: single-ascending dose Single doses of HM15275 placebo in healthy adults administered via subcutaneous injection. Part B: multiple-ascending dose Multiple doses of HM15275 placebo in obese adults administered via subcutaneous injection.
Placebo of HM15275	HM15275	Placebo comparator: Part A: single-ascending dose Single doses of HM15275 placebo in healthy adults administered via subcutaneous injection. Part B: multiple-ascending dose Multiple doses of HM15275 placebo in obese adults administered via subcutaneous injection.

Primary Outcome Measures

Name	Time	Method
Part A: Safety and Tolerability	Up to Day 29	Number of participants with treatment-emergent adverse events (TEAEs) after a single subcutaneous dose
Part B: Safety and Tolerability	Up to Day 57	Number of participants with treatment-emergent adverse events (TEAEs) after multiple subcutaneous doses

Secondary Outcome Measures

Name	Time	Method
Part A: Pharmacokinetics	Up to Day 29	Plasma concentration profile of HM15275 over time after a single subcutaneous dose
Part B: Pharmacokinetics	Up to Day 57	Plasma concentration profile of HM15275 over time after multiple subcutaneous doses

Trial Locations

Locations (1)

ProSciento, Inc.; 🇺🇸 Chula Vista, California, United States