Type 2 DiabetesPhase 2NCT07109700
A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin
A Phase 2 study testing HDM1005 1, HDM1005 2 and HDM1005 3 in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HDM1005 1, HDM1005 2 and HDM1005 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
About this study
Official title: 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- HDM1005 1, HDM1005 2, HDM1005 3, HDM1005 4, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1005 1Drug
administered SC, QW, 20 weeks
HDM1005 2Drug
administered SC, QW, 20 weeks
HDM1005 3Drug
administered SC, QW, 20 weeks
HDM1005 4Drug
administered SC, QW, 20 weeks
PlaceboDrug
administered SC, QW, 20 weeks
Dulaglutide 1.5 MGDrug
administered SC, QW, 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: HDM1005 1 | Experimental | HDM1005 administered subcutaneously (SC) Receives: Drug: HDM1005 1 |
| Experimental group: HDM1005 2 | Experimental | HDM1005 administered SC Receives: Drug: HDM1005 2 |
| Experimental group: HDM1005 3 | Experimental | HDM1005 administered SC Receives: Drug: HDM1005 3 |
| Experimental group: HDM1005 4 | Experimental | HDM1005 administered SC Receives: Drug: HDM1005 4 |
| Placebo group | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| Active Comparator: Dulaglutide | Active comparator | Dulagutide administered SC Receives: Drug: Dulaglutide 1.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Measured: Baseline, Week 20
Secondary outcomes (4)
Change from baseline in HbA1c
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Baseline, Week 12
The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0%
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Week 20
Change frome baseline in fasting plasma glucose (FPG)
FPG is a test to determine sugar levels in serum sample after an overnight fast.
Measured: Baseline, Week 12 and Week 20
Change from baseline in body weight
Change from baseline in body weight is calculated by subtracting the baseline weight measurement from the post-treatment weight measurement at a specified time point.
Measured: Baseline, Week 12 and Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start30 Apr 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109700
- Sponsor's protocol ID
- HDM1005-201
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07109700
- Acronym / sponsor ID
- HDM1005-201
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental group: HDM1005 1 | Experimental | Drug: HDM1005 1HDM1005 administered subcutaneously (SC) |
| Experimental group: HDM1005 2 | Experimental | Drug: HDM1005 2HDM1005 administered SC |
| Experimental group: HDM1005 3 | Experimental | Drug: HDM1005 3HDM1005 administered SC |
| Experimental group: HDM1005 4 | Experimental | Drug: HDM1005 4HDM1005 administered SC |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| Active Comparator: Dulaglutide | Active comparator | Drug: Dulaglutide 1.5 MGDulagutide administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDM1005 1administered SC, QW, 20 weeks | Drug | Experimental group: HDM1005 1 |
| HDM1005 2administered SC, QW, 20 weeks | Drug | Experimental group: HDM1005 2 |
| HDM1005 3administered SC, QW, 20 weeks | Drug | Experimental group: HDM1005 3 |
| HDM1005 4administered SC, QW, 20 weeks | Drug | Experimental group: HDM1005 4 |
| Placeboadministered SC, QW, 20 weeks | Drug | Placebo group |
| Dulaglutide 1.5 MGadministered SC, QW, 20 weeks | Drug | Active Comparator: Dulaglutide |
Primary outcome
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 20
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
4 secondary outcomes
Change from baseline in HbA1c
Time frame: Baseline, Week 12
The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0%
Time frame: Week 20
Change frome baseline in fasting plasma glucose (FPG)
Time frame: Baseline, Week 12 and Week 20
Change from baseline in body weight
Time frame: Baseline, Week 12 and Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDM1005 1, HDM1005 2 and HDM1005 3 in people with Type 2 Diabetes, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lepeng Li (+86 18301051549, lilepeng@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.