Obesity & OverweightPhase 3NCT07279194
Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes
A Phase 3 study testing HDM1005 1 and HDM1005 2 in people with Obesity & Overweight, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- HDM1005 1 and HDM1005 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 825 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2025to 13 Dec 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years at the time of signing informed consent.
- BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain.
- A self-reported change in body weight no more than 5% within 90 days before screening.
- Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.
Who cannot join
- Have type 1 diabetes mellitus (T1DM) or T2DM.
- Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.
- Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
- Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to screening.
- Use of hypoglycemic drugs within 3 months prior to screening.
- History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.
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- Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history.
- PHQ questionnaire ≥ 15 points at screening or randomization.
- Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past.
- Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).
- History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
- History of severe cardiovascular or cerebrovascular diseases within the past six months.
- History of alcohol and drug abuse at screening.
- The participant may be allergic to ingredients in the study drug or drugs of the same class.
- Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study.
- The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.
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
Zhongshan Hoapital
Shanghai
Xiaoying Li, +86 021-64041990, Xiaoying_li@Hotmail.com
About this study
Official title: Efficacy and Safety of HDM1005 Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
- Conditions
- Obesity & Overweight
- Being tested
- HDM1005 1, HDM1005 2, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1005 1Drug
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.
HDM1005 2Drug
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.
PlaceboDrug
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.
| Study group | Role | What they receive |
|---|---|---|
| HDM1005 Cohort 1 | Experimental | Not described Receives: Drug: HDM1005 1 |
| HDM1005 Cohort 2 | Experimental | Not described Receives: Drug: HDM1005 2 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome
The percentage change in body weight from baseline to week 40
Measured: week 40
Co-primary outcome
Proportion of subjects with body weight reduction ≥ 5% at Week 40.
Measured: week 40
Secondary outcomes (8)
secondary outcome
The proportion of participants reaching a body weight loss of at least 10% and 15% at week 40
Measured: week 40
secondary outcome
Change in waist circumference, body weight and BMI at week 40
Measured: week 40
secondary outcome
Change in waist circumference, body weight and BMI at week 52
Measured: week 52
secondary outcome
Change in systolic blood pressure (SBP), diastolic blood pressure (DBP) and lipids at week 40
Measured: week 40
secondary outcome
Change in SBP, DBP and lipids at week 52
Measured: week 52
safety outcome
the incidence of adverse events
Measured: week 52
patient report outcome
36-Item Short Form Health Survey, Version 2 questionnaire (scores range from 0 to 100, with higher scores indicating better health status) after administration for 52 weeks.
Measured: week 52
Immunogenicity outcome
ADA and NAb
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start14 Oct 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoying Li, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279194
- Sponsor's protocol ID
- HDM1005-301
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HDM1005 Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07279194
- Acronym / sponsor ID
- HDM1005-301
- Conditions
- Obesity & Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 12 Dec 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 is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HDM1005 Cohort 1 | Experimental | Drug: HDM1005 1 |
| HDM1005 Cohort 2 | Experimental | Drug: HDM1005 2 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged ≥18 years at the time of signing informed consent.
- BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain.
- A self-reported change in body weight no more than 5% within 90 days before screening.
- Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.
Key exclusion criteria (16 listed)
- Have type 1 diabetes mellitus (T1DM) or T2DM.
- Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.
- Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
- Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to screening.
- Use of hypoglycemic drugs within 3 months prior to screening.
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 1Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. | Drug | HDM1005 Cohort 1 |
| HDM1005 2Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total. | Drug | HDM1005 Cohort 2 |
| PlaceboInitiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total. | Drug | Placebo |
Primary outcome
primary outcome
Time frame: week 40
The percentage change in body weight from baseline to week 40
Co-primary outcome
Time frame: week 40
Proportion of subjects with body weight reduction ≥ 5% at Week 40.
8 secondary outcomes
secondary outcome
Time frame: week 40
secondary outcome
Time frame: week 40
secondary outcome
Time frame: week 52
secondary outcome
Time frame: week 40
secondary outcome
Time frame: week 52
safety outcome
Time frame: week 52
patient report outcome
Time frame: week 52
Immunogenicity outcome
Time frame: week 52
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 12 Dec 2025.
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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.
Xiaoying Li principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDM1005 1 and HDM1005 2 in people with Obesity & Overweight, 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 4 inclusion and 16 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 12 Dec 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hui Qiao (+86 0571-89908523, qiaohui@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome (time frame: week 40). The study lists 2 primary outcomes in all. 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 12 Dec 2025.