180 Participants NeededMy employer runs this trial

HM15275 for Type 2 Diabetes

Recruiting at 15 trial locations
PN
HC
Overseen ByHyeonho Choi
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Hanmi Pharmaceutical Company Limited
Must be taking: Metformin
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, an experimental drug, to evaluate its effectiveness for people with type 2 diabetes. The goal is to determine if this treatment can safely manage blood sugar levels over 36 weeks. Participants will receive either HM15275 through an injection or a placebo, a substance with no therapeutic effect, to compare results. This trial suits those with type 2 diabetes who manage their condition with diet, exercise, or metformin and have stable weight. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications?

If you are taking medications other than metformin for your diabetes, you will need to stop them at least 3 months before joining the trial. If you are on metformin, you can continue taking it as long as the dose is stable.

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

Research has shown that HM15275 has been well tolerated in earlier studies. One study found that doses up to 4 mg did not cause any serious side effects. The safety profile of HM15275 resembles that of other treatments used to control blood sugar, with side effects aligning with those typically expected from these drugs. The treatment is designed for once-weekly administration, and studies support the safety of this schedule. Overall, HM15275 has demonstrated a good safety record in studies to date.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about HM15275 for Type 2 Diabetes because it introduces a novel approach through subcutaneous injection, which could provide a more consistent and predictable release of medication compared to traditional oral medications like metformin or sulfonylureas. Unlike many current treatments that primarily focus on controlling blood glucose levels, HM15275 may offer additional benefits in metabolic regulation, potentially addressing more underlying aspects of diabetes. This new mechanism of action could not only enhance blood sugar management but also improve overall metabolic health, making it a promising candidate in the diabetes treatment landscape.

What evidence suggests that HM15275 might be an effective treatment for type 2 diabetes?

Research has shown that HM15275 could be a promising treatment for type 2 diabetes. Studies have demonstrated that this drug leads to significant early weight loss, which is crucial for managing diabetes. HM15275 targets three different pathways in the body to improve sugar processing and aid weight loss. Early results from related studies indicated that some participants lost up to 10% of their weight, suggesting its potential effectiveness in treating diabetes. The drug's balanced effects and once-a-week dosing offer a convenient option for patients. Participants in this trial will receive either HM15275 or a placebo via subcutaneous injection.12356

Are You a Good Fit for This Trial?

This trial is for adults aged 18–75 with type 2 diabetes, either managing it with diet/exercise or stable metformin use. Participants should have a BMI between 25 and 50, relatively stable weight, and HbA1c between 7% and 10%. People with certain cancers, pancreatitis history, severe heart or kidney issues, or recent use of other diabetes drugs can't join.

Inclusion Criteria

I manage my condition with diet, exercise, or stable metformin for at least 3 months.
BMI ≥25 kg/m² and ≤50 kg/m²
Body weight change <5% over the past 3 months prior to screening
See 3 more

Exclusion Criteria

I or my family have a history of medullary thyroid cancer or MEN2.
I have had pancreatitis or have risk factors for it.
Poor glycemic control (fasting plasma glucose >270 mg/dL)
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive weekly subcutaneous injections of HM15275 or placebo for 36 weeks

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 tests HM15275 versus a placebo in people with type 2 diabetes over about nine months (36 weeks). It aims to see how well HM15275 works and how safe it is compared to no active treatment. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

2

Treatment 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

NCT07527650 | Study to Evaluate HM15275 in Subjects ...

This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus ...

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 ...

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes ...

This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus ...

HM15275 for Type 2 Diabetes · Info for Participants

This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes ...

NCT07205900 | 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 Diabetes Mellitus.

HM15275 | Pipeline

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