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Completed

NCT Number: NCT06481098

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ProSciento, Inc.

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female and male adults, ages ≥ 18 and ≤ 65 years.
  • 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%).

  • HbA1c < 6.5 % [based on American Diabetes Association, 2023].
  • Female subjects must be non-pregnant and non-lactating.
  • Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.

Exclusion criteria

  • 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.
  • 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.
  • 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.
  • Subjects with confirmed type 1 or type 2 diabetes.
  • 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.
  • Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the Follow-up visit.
  • History of alcohol abuse as judged by the Investigator within approximately 1 year prior to Screening.
  • 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.

Treatment and study plan

HM15275

Drug

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

Placebo of HM15275

Drug

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

Primary outcomes

  1. Part A: Safety and Tolerability

    Time frame: Up to Day 29

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

  2. Part B: Safety and Tolerability

    Time frame: Up to Day 57

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

Secondary outcomes

  1. Part A: Pharmacokinetics

    Time frame: Up to Day 29

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

  2. Part B: Pharmacokinetics

    Time frame: Up to Day 57

    Plasma concentration profile of HM15275 over time after multiple subcutaneous doses

Other outcomes

  1. Part A: Pharmacodynamics

    Time frame: Up to Day 29

    Change in body weight (kg) from baseline

  2. Part B: Pharmacodynamics

    Time frame: Up to Day 57

    Change in body weight (kg) from baseline

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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