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

NCT06481098 | Completed Phase 1 FDA Drug

• 1 other identifier: HM-OBCT-101
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Part A: Pharmacokinetics

  Up to Day 29

• Part B: Pharmacokinetics

  Up to Day 57

Other Outcomes (2)

• Part A: Pharmacodynamics

  Up to Day 29

• Part B: Pharmacodynamics

  Up to Day 57

Study Arms (2)

HM15275

EXPERIMENTAL

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 of HM15275

PLACEBO COMPARATOR

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

HM15275 DRUG

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

HM15275; Placebo of HM15275

Placebo of HM15275 DRUG

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

HM15275; Placebo of HM15275

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

ProSciento, Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: single-ascending dose Part B: multiple-ascending dose

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: July 1, 2024
• Study Start: May 28, 2024
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (1)