Obesity ControlPhase 3NCT07036172
Efficacy and Safety of Semaglutide Injection Vs WEGOVY® in Chinese Obese Patients
A Phase 3 study testing HDM1702 and Wegovy ® in people with Obesity Control, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity Control
- What is being tested?
- HDM1702 and Wegovy ®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2025to May 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent；
- BMI ≥28 kg/m2；
- A self-reported change in body weight no more than 5% within 90 days before screening.
Who cannot join
- History of type 1 and type 2 diabetes;
- Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
- History or presence of chronic or acute pancreatitis;
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma;
- A history or presence of suspected depression or other mental disorders;
- Patient Health Questionnaire-9 score of ≥15 at screening
- Uncontrolled hypertension, any of the following: myocardial infarction, stroke, hospitalisation for unstable angina, or transient ischaemic attack within the past 6 months prior to screening;
- History of malignant neoplasms within the past 5 years prior to screening;
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
Linong Ji, Medical Doctor, +8601088324516, jiln@bjmu.edu.cn
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection and WEGOVY® in Chinese Obese Patients
This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 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 Control
- Being tested
- HDM1702, Wegovy ®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1702Drug
Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16.
Wegovy ®Drug
Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16.
| Study group | Role | What they receive |
|---|---|---|
| HDM1702 | Experimental | Not described Receives: Drug: HDM1702 |
| WEGOVY® | Active comparator | Not described Receives: Drug: Wegovy ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in body weight from baseline to week 44
Measured: week 44
Secondary outcomes (5)
The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 44
Measured: week 44
Change in waist circumference, body weight and BMI at week 44
Measured: week 44
Change in blood pressure and lipids at week 44
Measured: week 44
Adverse events
Measured: week 44
ADA and NAb
Measured: week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start3 Jan 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity ControlStudies 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
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036172
- Sponsor's protocol ID
- HDM1702-301
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 25 Jun 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection and WEGOVY® in Chinese Obese Patients
- ClinicalTrials.gov ID
- NCT07036172
- Acronym / sponsor ID
- HDM1702-301
- Conditions
- Obesity Control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 25 Jun 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 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HDM1702 | Experimental | Drug: HDM1702 |
| WEGOVY® | Active comparator | Drug: Wegovy ® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged ≥18 years and ≤75 years at the time of signing informed consent；
- BMI ≥28 kg/m2；
- A self-reported change in body weight no more than 5% within 90 days before screening.
Key exclusion criteria (8 listed)
- History of type 1 and type 2 diabetes;
- Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
- History or presence of chronic or acute pancreatitis;
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma;
- A history or presence of suspected depression or other mental disorders;
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 |
|---|---|---|
| HDM1702Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16. | Drug | HDM1702 |
| Wegovy ®Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16. | Drug | WEGOVY® |
Primary outcome
The percentage change in body weight from baseline to week 44
Time frame: week 44
5 secondary outcomes
The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 44
Time frame: week 44
Change in waist circumference, body weight and BMI at week 44
Time frame: week 44
Change in blood pressure and lipids at week 44
Time frame: week 44
Adverse events
Time frame: week 44
ADA and NAb
Time frame: week 44
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 25 Jun 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.
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 HDM1702 and Wegovy ® in people with Obesity Control, 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 8 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 25 Jun 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change in body weight from baseline to week 44 (time frame: week 44). 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 25 Jun 2025.