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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HM15275 to assess its safety and behavior in the body. It involves healthy individuals and those with obesity. In Part A, healthy adults receive a single dose, while in Part B, adults with obesity receive multiple doses. Individuals with a stable body weight and a BMI of 30 to 45 may qualify for the obesity part of this study. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that HM15275 is likely to be safe for humans?

Research has shown that HM15275 is generally safe for people. In one study, doses up to 4 mg caused no serious side effects. The safety profile of HM15275 resembles that of other diabetes treatments. Thus, HM15275 appears safe, with no major safety issues reported so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HM15275 for obesity because it introduces a novel approach compared to existing treatments like appetite suppressants, fat absorption inhibitors, and metabolic enhancers. Unlike these traditional options, HM15275 is delivered through subcutaneous injection, potentially offering more direct and efficient absorption. Furthermore, HM15275 may work by targeting specific pathways in fat metabolism, which could lead to more effective weight loss outcomes. This innovative mechanism could offer a new solution for individuals struggling with obesity, especially those who have not had success with current treatments.

What evidence suggests that HM15275 might be an effective treatment for obesity?

Research has shown that HM15275, which participants in this trial may receive, may aid weight loss in people with obesity. One study found that participants lost nearly 5% of their body weight in just four weeks, with some losing up to 10%. Another study in mice demonstrated a 39.9% weight loss compared to other treatments. These findings suggest that HM15275 could be a powerful medication for managing weight. However, further research is needed to confirm its long-term safety and effectiveness in humans. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07205900

A Phase 2 Study to Evaluate HM15275 in Obese or ... This Study is a Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Obese or Overweight Subjects Without ...

2. hanmipharm.com hanmipharm.com/about/investor-relations/press/detail-2162.hm

Hanmi's Next-Gen Obesity Drug Gains Momentum Hanmi's Next-Gen Obesity Drug Gains Momentum: Nearly 5% Weight Loss After 4 Weeks, Up to 10% in Individual Case Hanmi Showcases Six Research ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/1980-LB/159987/1980-LB-Safety-Tolerability-and-Pharmacokinetics

Safety, Tolerability, and Pharmacokinetics of HM15275, a ... Findings suggest clinically meaningful early weight loss, warranting further evaluation for long-term efficacy and durability in obesity and ...

4. hanmi.co.kr hanmi.co.kr/science-pdf/HM15275/2025_EASD_Poster_HM15275_765.pdf

Mechanistic Insights into the Potent Anti-Obesity Effects of ... Results: In DIO mice, a 3-week treatment with HM15275 resulted in greater BWL (-39.9% vs. baseline) compared to SEMA (-14.9%) and TZP. (-25.3 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06481098

NCT06481098 | A Phase 1 Study to Assess HM15275 in ... This study is a Phase 1 study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of HM15275 in healthy and obese subjects.

6. hanmipharm.com hanmipharm.com/science/pipeline/focused/hm15275.hm

HM15275 | Pipeline HM15275, a major pipeline of Hanmi Pharmaceutical, is being studied for the purpose of treating obesity and cardiovascular renal metabolism diseases.

7. hanmi.co.kr hanmi.co.kr/science-pdf/HM15275/2025_ADA_Poster_HM15275_1980-LB.pdf

Safety, Tolerability, and Pharmacokinetics of HM15275, a ... HM15275 was safe and well tolerated, consistent with safety profile of incretin-based therapies. The favorable safety and.