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NCT06481098CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 22 May 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
74 (actual)
First submitted
30 May 2024
Start date
28 May 2024
Primary completion date
2 May 2025
Lead sponsor
Hanmi Pharmaceutical Company Limited
Diseases
Obesity
NCT number
NCT06481098

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 74
  • From 28 May 2024 to the primary completion date, 2 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • 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.

Age

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ProSciento, Inc.
Coordinator of this site? Confirm its status
Chula VistaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.