A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin

Launched by HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. · Jul 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called HDM1005 to see if it can help people with Type 2 Diabetes who are not able to control their blood sugar well enough through diet, exercise, or the commonly used diabetes medicine metformin. The study will compare different doses of HDM1005 to a placebo (a “dummy” treatment) and to another diabetes medicine called dulaglutide. Researchers want to find out how well HDM1005 works, whether it is safe, and how the body processes it.

People who might be eligible for this trial are adults who have had Type 2 Diabetes for at least six months, with blood sugar levels that are higher than recommended (measured by a test called HbA1c between 7.5% and 10.5%), and who have a body weight within a certain range. Participants should not have recently used other diabetes medicines or have certain health conditions like serious thyroid problems or pancreatitis. If chosen for the study, participants will go through a 2-week screening, take the study medicine or placebo for about 20 weeks, and then have a 4-week follow-up to check their safety. The study involves regular visits to the clinic to monitor blood sugar, side effects, and overall health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 24 weeks;
• • Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%
• • Body Mass Index (BMI within the range of 22.5 \~ 40.0 kg/m2
• Exclusion Criteria:
• • Other types of diabetes besides T2DM
• • Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF)
• • History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF
• • History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2)
• • History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease within 24 weeks prior to signing the ICF
• • Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis
• • Use of antidiabetic medications within 12 weeks prior to signing the ICF
• • Hemoglobin (Hb) \<100 g/L (female) or \<110 g/L (male)
• • FPG ≥13.9 mmol/L
• • Aspartate aminotransferase (AST) \>2.5× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>2.5× ULN
• • Total bilirubin \>1.5× ULN
• • Fasting triglyceride (TG) \>5.6 mmol/L (500 mg/dL)