HDM1005 injections for adults with type 2 diabetes not controlled by diet and exercise

A Multicenter, Randomized, Double-blind, Placebo-Controlled , Phase 3 Study Comparing the Efficacy and Safety of HDM1005 Versus Placebo in Subjects With T2DM Inadequate Glycemic Control With Diet and Exercise Alone

This trial will test whether HDM1005 injections help adults with type 2 diabetes whose blood sugar isn't controlled by diet and exercise alone.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Beijing)
• Trial ID: NCT07394114 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 3 trial will enroll 240 adults with type 2 diabetes inadequately controlled by diet and exercise to test two dose regimens of HDM1005 against placebo. Participants will be stratified by baseline HbA1c (≤8.5% or >8.5%) and randomized 1:1:1 to two HDM1005 dose groups or placebo, with dose titration used to reach target doses. The core treatment period is 36 weeks, after which participants on placebo switch to HDM1005 until week 52, followed by a 4-week follow-up for safety. The study includes up to 2-week screening, a 2-week run-in, a 16-week extension, and an end-of-study visit 28 days after the last dose.

Who should consider this trial

Good fit: Adults with type 2 diabetes for at least 12 weeks who have not used antihyperglycemic medications for at least 12 weeks, have HbA1c in the study-specified ranges at screening and randomization, and a BMI ≥22.5 kg/m2.

Not a fit: Patients with other types of diabetes, recent acute diabetic complications, a history of severe or frequent hypoglycemia, personal or family history of medullary thyroid carcinoma or MEN2, or a history or risk factors for pancreatitis are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, HDM1005 could help lower HbA1c and improve blood sugar control for people with T2DM who cannot manage glucose with diet and exercise alone.

How similar studies have performed: HDM1005 has advanced to Phase 3 after earlier clinical testing, suggesting prior data supported further study, but large-scale efficacy and long-term safety remain unproven.

Eligibility criteria

Inclusion Criteria:

1. Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 12 weeks and have not used any antihyperglycemic medications during for at least 12 weeks prior to screening.
2. Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% at screening; and ≥7.0% and ≤10.5% at randomization.
3. Body Mass Index (BMI) ≥22.5 kg/m2.

Exclusion Criteria:

1. Other types of diabetes besides T2DM.
2. Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketoticcoma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF).
3. History of a level 3 hypoglycemic episode or a history of asymptomatic hypoglycemic episodes within 24 weeks prior to signing the ICF.
4. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
5. History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease requiring treatment per investigator's assessment within 24 weeks prior to signing the ICF.
6. 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.
7. Use of any antidiabetic medications within 12 weeks prior to signing the ICF; excluding short-term insulin use (cumulative duration ≤7 days) for concomitant illness, stress, or perioperative periods.
8. Hemoglobin (Hb) \<100 g/L (female) or \<110 g/L (male).
9. FPG ≥13.9 mmol/L.
10. Aspartate aminotransferase (AST) \>3× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3× ULN.
11. Total bilirubin \>1.5× ULN.
12. Fasting triglyceride (TG) \>5.6 mmol/L (500 mg/dL).

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Wenyan Cao

Conditions: Type 2 Diabetes