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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: HM15275; Drug: Placebo of HM15275

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • ProSciento, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.; Drug: Placebo of HM15275; A sterile, matching solution supplied in pre-filled syringes.
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; HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.; Drug: Placebo of HM15275; A sterile, matching solution supplied in pre-filled syringes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Safety and Tolerability	Number of participants with treatment-emergent adverse events (TEAEs) after a single subcutaneous dose	Up to Day 29
Part B: Safety and Tolerability	Number of participants with treatment-emergent adverse events (TEAEs) after multiple subcutaneous doses	Up to Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Pharmacokinetics	Plasma concentration profile of HM15275 over time after a single subcutaneous dose	Up to Day 29
Part B: Pharmacokinetics	Plasma concentration profile of HM15275 over time after multiple subcutaneous doses	Up to Day 57

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Pharmacodynamics	Change in body weight (kg) from baseline	Up to Day 29
Part B: Pharmacodynamics	Change in body weight (kg) from baseline	Up to Day 57

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): May 2, 2025
• Study Completion (Actual): May 2, 2025

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: HM-OBCT-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No