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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2025-05-02

Brief Summary

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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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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

HM15275

Intervention Type DRUG

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

Placebo of HM15275

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

HM15275

Intervention Type DRUG

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

Placebo of HM15275

Intervention Type DRUG

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

Interventions

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HM15275

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

Intervention Type DRUG

Placebo of HM15275

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes