HM15275 for Obesity

Not yet recruiting at 11 trial locations
GP
Overseen ByGaeun Park
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Hanmi Pharmaceutical Company Limited
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HM15275 to determine its safety and effectiveness in helping people who are overweight or obese lose weight. The study compares HM15275 to a placebo (a look-alike injection with no active drug) to evaluate its efficacy over 36 weeks. Suitable candidates for this trial include individuals with a body mass index (BMI) of 30 or above, or a BMI of 27 or above with at least one weight-related health issue, who have not experienced significant weight changes recently. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a potentially effective weight-loss solution.

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

The trial information does not specify if you need to stop taking your current medications. However, you cannot have taken weight loss drugs in the 90 days before the screening.

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 studies, participants took doses up to 4 mg without experiencing serious side effects. The safety profile of HM15275 is similar to other treatments used to manage blood sugar levels, indicating that most people did not encounter unexpected side effects. These findings suggest that HM15275 could be a promising treatment for obesity, with a safety record that supports further testing.12345

Why do researchers think this study treatment might be promising for obesity?

Most treatments for obesity focus on appetite suppression or inhibiting fat absorption, like orlistat or GLP-1 receptor agonists. But HM15275 works differently, targeting the body's metabolic processes to enhance energy expenditure and reduce fat accumulation. Administered via subcutaneous injection, it's designed to not only aid in weight loss but also potentially improve metabolic health markers. Researchers are excited because this novel approach could offer an effective alternative for those who struggle with existing options.

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

Studies have shown that HM15275, which participants in this trial may receive, can help people lose a significant amount of weight. In earlier research, participants lost nearly 5% of their body weight after just four weeks, with some losing up to 10%. In animal studies, HM15275 led to a 39.9% reduction in body weight, proving more effective than other treatments tested. These results suggest that HM15275 could be a strong option for people struggling with obesity. The treatment targets specific parts of the body that control hunger and fat storage.12467

Are You a Good Fit for This Trial?

This trial is for individuals who are obese or overweight but do not have diabetes. Participants will be involved in the study for 36 weeks to assess the effectiveness and safety of a new treatment.

Inclusion Criteria

Body weight change <5% over the past 3 months prior to screening
I am between 18 and 75 years old (or 19-75 if I am in Korea).
My BMI is between 27 and 50, and I may have a weight-related health issue.
See 1 more

Exclusion Criteria

I have diabetes or my blood sugar levels are high.
My obesity is caused by a hormonal or genetic condition.
I haven't had recent obesity surgery or device-based treatments.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive HM15275 or placebo via subcutaneous injection for 36 weeks, including a dose-titration phase

36 weeks

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, which is potentially a new medication for obesity. Some participants will receive HM15275, while others will get a placebo (a substance with no active drug) to compare results.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HM15275Experimental Treatment1 Intervention
Group II: Placebo of HM15275Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hanmi Pharmaceutical Company Limited

Lead Sponsor

Trials
196
Recruited
62,100+
Young Choi profile image

Young Choi

Hanmi Pharmaceutical Company Limited

Chief Medical Officer since 2023

PhD in Pharmacology from Yonsei University

Jae-Hyun Park profile image

Jae-Hyun Park

Hanmi Pharmaceutical Company Limited

Chief Executive Officer since 2024

MD from Seoul National University

Citations

Hanmi's Next-Gen Obesity Drug Gains MomentumHanmi's Next-Gen Obesity Drug Gains Momentum: Nearly 5% Weight Loss After 4 Weeks, Up to 10% in Individual Case
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 ...
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%).
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 ...
Hanmi Pharmaceutical reveals Phase 1 results for triple ...Hanmi Pharmaceutical has released the first clinical data from its next-generation triple agonist obesity drug, HM15275, showing promising early efficacy.
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.
A Phase 1 Study to Assess HM15275 in Healthy and Obese ...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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