A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin
NCT ID: NCT07109700
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
216 participants
INTERVENTIONAL
2025-04-30
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
NCT06481085
Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
NCT07193459
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
NCT02077452
Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus
NCT06498284
A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
NCT07082114
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group: HDM1005 1
HDM1005 administered subcutaneously (SC)
HDM1005 1
administered SC, QW, 20 weeks
Experimental group: HDM1005 2
HDM1005 administered SC
HDM1005 2
administered SC, QW, 20 weeks
Experimental group: HDM1005 3
HDM1005 administered SC
HDM1005 3
administered SC, QW, 20 weeks
Experimental group: HDM1005 4
HDM1005 administered SC
HDM1005 4
administered SC, QW, 20 weeks
Placebo group
Placebo administered SC
Placebo
administered SC, QW, 20 weeks
Active Comparator: Dulaglutide
Dulagutide administered SC
Dulaglutide 1.5 MG
administered SC, QW, 20 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HDM1005 1
administered SC, QW, 20 weeks
HDM1005 2
administered SC, QW, 20 weeks
HDM1005 3
administered SC, QW, 20 weeks
HDM1005 4
administered SC, QW, 20 weeks
Placebo
administered SC, QW, 20 weeks
Dulaglutide 1.5 MG
administered SC, QW, 20 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%
* Body Mass Index (BMI within the range of 22.5 \~ 40.0 kg/m2
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HDM1005-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.