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

Completed · Phase 1 · Has a placebo group

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT06481098

Run by

Hanmi Pharmaceutical Company Limited

People needed

74

Starts

2024-05-28

Expected to finish

2025-05-02

Last updated by the study team

2025-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ProSciento, Inc. — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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