HM15275 for Obesity

Overseen By Elaine Watkins, DO, MSPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hanmi Pharmaceutical Company Limited

Must not be taking: GLP-1, GIP, glucagon

Disqualifiers: Diabetes, Malignancy, Alcohol abuse, others

Compensation: Varies

Number of Visits: 1

74 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for healthy individuals as well as those who are obese. Specific details about who can join, such as age range or health status, aren't provided here.

Inclusion Criteria

HbA1c < 6.5% [based on American Diabetes Association, 2023]

Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration

My BMI is between 30.0 and 45.0, and my weight has been stable for the last 3 months.

Exclusion Criteria

I have been cancer-free for less than 5 years, excluding certain skin and in situ cancers.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single-ascending dose of HM15275 or placebo administered via subcutaneous injection in healthy adults

4 weeks

1 visit (in-person)

Treatment Part B

Multiple-ascending doses of HM15275 or placebo administered via subcutaneous injection in obese adults

8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HM15275

Trial Overview The study is testing HM15275 against a placebo to see how safe it is and how the body responds to it. It's in Phase 1, which usually means they're starting with small doses to check safety.

Participant Groups

Group I: HM15275 Experimental Treatment 2 Interventions

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 II: Placebo of HM15275 Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

Hanmi Pharmaceutical Company Limited

Lead Sponsor

Trials

196

Recruited

62,100+

Young Choi

Hanmi Pharmaceutical Company Limited

Chief Medical Officer since 2023

PhD in Pharmacology from Yonsei University

Jae-Hyun Park

Hanmi Pharmaceutical Company Limited

Chief Executive Officer since 2024

MD from Seoul National University