Recruiting PHASE2 Type 2 Diabetes Mellitus

New treatment option for Type 2 Diabetes Mellitus

Official title Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

ClinicalTrials.gov ID: NCT07527650

What this study is testing

What is HM15275?

HM15275 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for type 2 diabetes mellitus.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.
  • Phase 2: a mid-size study of how well it works
  • Time commitment: about 36 weeks
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • Key 1. Participant's age at the time of signing the informed consent:
  • United States: 18 to 75 years (inclusive)
  • Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
  • Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
  • BMI ≥25 kg/m² and ≤50 kg/m²

You likely can't join if

  • Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
  • Poor glycemic control (fasting plasma glucose \>270 mg/dL)
  • History of diabetic ketoacidosis or severe hypoglycemia within 6 months
  • Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization...
  • History of pancreatitis or factors increasing the risk of pancreatitis
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
See the full eligibility criteria
Who can join
  • Key 1. Participant's age at the time of signing the informed consent:
  • United States: 18 to 75 years (inclusive)
  • Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
  • Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
  • BMI ≥25 kg/m² and ≤50 kg/m²
  • Body weight change \<5% over the past 3 months prior to screening
  • Capable of giving signed informed consent and willing to comply with all protocol procedures Key
What rules you out
  • Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
  • Poor glycemic control (fasting plasma glucose \>270 mg/dL)
  • History of diabetic ketoacidosis or severe hypoglycemia within 6 months
  • Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
  • History of pancreatitis or factors increasing the risk of pancreatitis
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
  • Clinically significant liver disease, renal impairment (eGFR \<60 mL/min/1.73 m²), or abnormal laboratory findings at screening
  • Participation in another investigational study within 30 days or within 5 half-lives of the investigational product, whichever is longer; for GLP-1 receptor agonist-related or weight loss studies, participation within 3...

The study team makes the final eligibility decision.

Where it's taking place

  • Mesa, Arizona, United States
  • Orlando, Florida, United States
  • Columbus, Georgia, United States
  • South Bend, Indiana, United States
  • Jefferson City, Missouri, United States
  • Kansas City, Missouri, United States
  • Fremont, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Morehead City, North Carolina, United States
  • Columbus, Ohio, United States
  • Salt Lake City, Utah, United States
  • Manassas, Virginia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 36 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Mesa, Arizona, United States; Orlando, Florida, United States; Columbus, Georgia, United States; South Bend, Indiana, United States; Jefferson City, Missouri, United States; Kansas City, Missouri, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.