NCT07109700RecruitingPhase 2
A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin
A Randomized, Double-blind, Placebo and Active Comparator-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HDM1005 in Subjects With T2DM With Inadequate Glycemic Control After Diet/Exercise or Metformin Therapy
Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a multicenter, randomized, double-blind (with open-label dose levels and active comparator), parallel-group, placebo- and active-controlled Phase 2 clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic (PK) characteristics of HDM1005 in subjects with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control after diet/exercise or metformin therapy. A total of 216 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) and prior metformin use, then randomized 1:1:1:1:1:1 to: Group 1 (HDM1005 0.5 mg), Group 2 (HDM1005 1.0 mg), Group 3 (HDM1005 2.0 mg), Group 4 (HDM1005 3.0 mg), Group 5 (Placebo), and Group 6 (open-lable dulaglutide 1.5 mg, active comparator), with 36 subjects in each treatment group. Within each dose cohort (0.5/1.0/2.0/3.0mg), there will be \~45 total subjects (36 HDM1005 + 9 placebo). The 1.0mg, 2.0mg, and 3.0mg cohorts will implement dose titration. The study consists of: 2-week screening, 20-week treatment, and 4-week safety follow-up. The end-of-study visit will be conducted 28 days after the last administration cycle.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 216 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- 30 Apr 2025
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07109700
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 216
- From 30 Apr 2025 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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
- Use of antidiabetic medications within 12 weeks prior to signing the ICF
Other illness
- Other types of diabetes besides T2DM
- History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2)
- 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
Lab values
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.