RightFit
RecruitingPhase 2

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Subjects With Type 2 Diabetes Mellitus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will undergo a 4-week screening period, a 36-week treatment period (including weekly subcutaneous \[SC\] injection of study drug), and a 4-week safety follow-up period."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 2 study tests how well HM15275 works for adults with type 2 diabetes over 36 weeks. It also checks its safety and how well people can handle its side effects.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • In the United States, you must be 18 to 75 years old when you sign the consent form.
  • You must have type 2 diabetes and an HbA1c of 7.0% to 10.0%. HbA1c measures your average blood sugar over time.
  • You must use diet and exercise alone, or have taken the same dose of metformin (at least 1,000 mg a day) for at least 3 months before screening.
  • Your BMI must be 25 to 50. BMI is a measure based on height and weight.
  • Your weight must have changed by less than 5% in the 3 months before screening.
  • You must be able to sign a consent form and willing to follow all study steps.

Who can't join

  • You have type 1 diabetes or used a diabetes medicine other than metformin in the 3 months before screening.
  • Your fasting blood sugar (measured after not eating) is above 270 mg/dL.
  • You had diabetic ketoacidosis (dangerous acid buildup linked to diabetes) or very low blood sugar within 6 months.
  • You have serious heart or blood vessel disease, such as severe heart failure, or had a heart attack, stroke, or procedure to restore blood flow within 3 months.
  • You have had pancreatitis (swelling of the pancreas) or have factors that raise your risk of it.
  • You or a family member has had medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes tumors in hormone-making glands.
  • You have serious liver disease, reduced kidney function (eGFR below 60), or abnormal lab test results at screening.
  • You joined another research study within 30 days, or within 5 half-lives of its study drug, whichever is longer. A half-life is the time for half a drug to leave the body. For GLP-1 drug or weight-loss studies, the limit is 3 months before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria 1. Participant's age at the time of signing the informed consent: * United States: 18 to 75 years (inclusive) 2. Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening 3. Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening 4. BMI ≥25 kg/m² and ≤50 kg/m² 5. Body weight change \<5% over the past 3 months prior to screening 6. Capable of giving signed informed consent and willing to comply with all protocol procedures Key Exclusion Criteria 1. Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening 2. Poor glycemic control (fasting plasma glucose \>270 mg/dL) 3. History of diabetic ketoacidosis or severe hypoglycemia within 6 months 4. Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months) 5. History of pancreatitis or factors increasing the risk of pancreatitis 6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 7. Clinically significant liver disease, renal impairment (eGFR \<60 mL/min/1.73 m²), or abnormal laboratory findings at screening 8. 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 months prior to screening

Study sites (20)

AZ

  • Desert Clinical Research · Mesa, AZ 85123Gerald Shockey · Principal investigatorMore trials in Mesa

CA

FL

  • Accel Research Sites - DeLand · DeLand, FL 32720Bruce Rankin · Principal investigatorMore trials in DeLand
  • Charter Research · Orlando, FL 32803Mary Hilal Quarterman · Principal investigatorMore trials in Orlando
  • AdventHealth Translational Research Institute · Orlando, FL 32804Richard Edwin Pratley · Principal investigatorMore trials in Orlando
  • K2 Medical Research The Villages LLC · The Villages, FL 32159Craig T Curtis · Principal investigatorMore trials in The Villages
  • Charter Research - The Villages · The Villages, FL 32162Stephen Mark Miller · Principal investigatorMore trials in The Villages

GA

  • Centricity Research IRT - DBA IACT Health Columbus Piedmont · Columbus, GA 31904Steven Leichter · Principal investigatorMore trials in Columbus

IL

IN

MO

NC

NE

NV

  • Santa Rosa Medical Centers of Nevada · Las Vegas, NV 89119Syed Pervaiz · Principal investigatorMore trials in Las Vegas

OH

TX

UT

VA

  • Manassas Clinical Research Center · Manassas, VA 20110Nabil Saleh Andrawis · Principal investigatorMore trials in Manassas