Overweight and ObesityPhase 3NCT06885021
Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults
A Phase 3 study testing HDM1002 200mg, oral, once daily, 52 weeks and HDM1002 400mg, oral, once daily, 52 weeks in people with Overweight and Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd..
Trial summary
A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- HDM1002 200mg, oral, once daily, 52 weeks and HDM1002 400mg, oral, once daily, 52 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 780 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2025to 30 Jun 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
- BMI≥28 but < 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but < 28 kg/m2 with any of the following:
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea syndrome
- MASH
- Pain in the weight-bearing joints
- At least one previous failure to lose weight through lifestyle modification was defined as < 5% weight loss after ≥3 months of lifestyle modification
Who cannot join
- Weight change ≥5% as reported or documented.
- Previous diagnosis of type 1, type 2, or any other type of diabetes.
- Diagnosis of overweight or obesity due to other diseases or medications.
- History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.
- Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
- GLP-1R agonist use within 6 months prior to signing ICF.
- Use of hypoglycemic drugs within 3 months before signing ICF.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults
A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
- Conditions
- Overweight and Obesity
- Being tested
- HDM1002 200mg, oral, once daily, 52 weeks, HDM1002 400mg, oral, once daily, 52 weeks, HDM1002 placebo, oral, once daily, 52 weeks
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1002 200mg, oral, once daily, 52 weeksDrug
HDM1002 200mg, oral, once daily, 52 weeks
HDM1002 400mg, oral, once daily, 52 weeksDrug
HDM1002 400mg, oral, once daily, 52 weeks
HDM1002 placebo, oral, once daily, 52 weeksDrug
HDM1002 placebo, oral, once daily, 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| HDM1002 tablets 200mg once daily | Experimental | HDM1002 200mg, oral, once daily, 52weeks Receives: Drug: HDM1002 200mg, oral, once daily, 52 weeks |
| HDM1002 tablets 400mg once daily | Experimental | HDM1002 400mg, oral, once daily, 52weeks Receives: Drug: HDM1002 400mg, oral, once daily, 52 weeks |
| Placebo | Placebo comparator | HDM1002 placebo, oral, once daily, 52weeks Receives: Drug: HDM1002 placebo, oral, once daily, 52 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Body Weight
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg,
Measured: 44weeks
Percentage Change of Participants Achieving Weight Loss ≥ 5%
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Measured: 44weeks
Secondary outcomes (3)
Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15%
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Measured: 44weeks
Change From Baseline in Waist Circumference
Waist Circumference was recorded in cm
Measured: 44 weeks, 52 weeks
Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15%
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start28 Mar 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- 780 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885021
- Sponsor's protocol ID
- HDM1002-301
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT06885021
- Acronym / sponsor ID
- HDM1002-301
- Conditions
- Overweight and Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Mar 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.
A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
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 |
|---|---|---|
| HDM1002 tablets 200mg once daily | Experimental | Drug: HDM1002 200mg, oral, once daily, 52 weeksHDM1002 200mg, oral, once daily, 52weeks |
| HDM1002 tablets 400mg once daily | Experimental | Drug: HDM1002 400mg, oral, once daily, 52 weeksHDM1002 400mg, oral, once daily, 52weeks |
| Placebo | Placebo comparator | Drug: HDM1002 placebo, oral, once daily, 52 weeksHDM1002 placebo, oral, once daily, 52weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI≥28 but < 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but < 28 kg/m2 with any of the following:
- At least one previous failure to lose weight through lifestyle modification was defined as < 5% weight loss after ≥3 months of lifestyle modification
Key exclusion criteria (7 listed)
- Weight change ≥5% as reported or documented.
- Previous diagnosis of type 1, type 2, or any other type of diabetes.
- Diagnosis of overweight or obesity due to other diseases or medications.
- History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.
- Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing 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 |
|---|---|---|
| HDM1002 200mg, oral, once daily, 52 weeksHDM1002 200mg, oral, once daily, 52 weeks | Drug | HDM1002 tablets 200mg once daily |
| HDM1002 400mg, oral, once daily, 52 weeksHDM1002 400mg, oral, once daily, 52 weeks | Drug | HDM1002 tablets 400mg once daily |
| HDM1002 placebo, oral, once daily, 52 weeksHDM1002 placebo, oral, once daily, 52 weeks | Drug | Placebo |
Primary outcome
Percentage Change From Baseline in Body Weight
Time frame: 44weeks
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg,
Percentage Change of Participants Achieving Weight Loss ≥ 5%
Time frame: 44weeks
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
3 secondary outcomes
Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15%
Time frame: 44weeks
Change From Baseline in Waist Circumference
Time frame: 44 weeks, 52 weeks
Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15%
Time frame: 52 weeks
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 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDM1002 200mg, oral, once daily, 52 weeks and HDM1002 400mg, oral, once daily, 52 weeks in people with Overweight and Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd..
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jing Liu Jing Liu (+8657189903388, cxyliujing@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline in Body Weight (time frame: 44weeks). 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 19 Mar 2025.