Obesity
Conditions
Keywords
Obesity
Brief summary
This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.
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
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Part A: single-ascending dose Part B: multiple-ascending dose
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Part A: Pharmacodynamics | Up to Day 29 | Change in body weight (kg) from baseline |
| Part B: Pharmacodynamics | Up to Day 57 | Change in body weight (kg) from baseline |
Countries
United States
Outcome results
None listed