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CompletedNCT06481098Updated May 22, 2025

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

A Phase 1 interventional study of HM15275 and Placebo of HM15275 in Obesity, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2025, 1 year 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 74 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    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.

    Drug: HM15275 · Drug: Placebo of HM15275

  • Placebo comparator
    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.

    Drug: HM15275 · Drug: Placebo of HM15275

Interventions

  • DrugHM15275

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

  • DrugPlacebo of HM15275

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

06

What researchers measure

Primary outcomes

  1. Part A: Safety and Tolerability

    Number of participants with treatment-emergent adverse events (TEAEs) after a single subcutaneous dose

    Time frame: Up to Day 29

  2. Part B: Safety and Tolerability

    Number of participants with treatment-emergent adverse events (TEAEs) after multiple subcutaneous doses

    Time frame: Up to Day 57

Secondary outcomes

  1. Part A: Pharmacokinetics

    Plasma concentration profile of HM15275 over time after a single subcutaneous dose

    Time frame: Up to Day 29

  2. Part B: Pharmacokinetics

    Plasma concentration profile of HM15275 over time after multiple subcutaneous doses

    Time frame: Up to Day 57

Other outcomes

  1. Part A: Pharmacodynamics

    Change in body weight (kg) from baseline

    Time frame: Up to Day 29

  2. Part B: Pharmacodynamics

    Change in body weight (kg) from baseline

    Time frame: Up to Day 57

07

Study locations

1 site
  • ProSciento, Inc.
    Chula Vista, California 91911, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06481098
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Jul 1, 2024
Start date
May 28, 2024
Primary completion
May 2, 2025
Completion
May 2, 2025
Last update
May 22, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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