Weight ManagementPhase 3NCT06604624
Semaglutide in Treatment of Obesity
A Phase 3 study testing HD1916 and semaglutide in people with Weight Management, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Management
- What is being tested?
- HD1916 and semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 24 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Age ≥18 years old (at the time of signing ICF), both male and female;
- BMI≥28 kg/m^2 during screening;
- Within 90 days before screening, the weight change range controlled by diet and exercise alone is less than 5% (see section 1.3 for the calculation formula);
- Voluntarily participate in the trial and sign the informed consent.
Who cannot join
- Meet any of the following requirements: (1) HbA1c≥6.5% or fasting venous blood glucose ≥7.0 mmol/L during screening; (2) a history of type 1 or type 2 or a specific type of diabetes;
- Obesity is caused by drugs or diseases (e.g. Cushing\'s syndrome, acromegaly, etc.); or weight gain caused by increased non-fat content (e.g. edema);
- Received (including) drug therapy with GLP-1 receptor agonists (single target, double target, or multiple target) within 90 days prior to screening;
- Received any other drug or product or treatment within 90 days prior to screening that the investigator determines will affect the assessment of weight efficacy of the trial, including but not limited to drugs or products or treatments that contain overweight/obesity or equivalent meaning in the label indications, hypoglycemic drugs, tricyclic antidepressants, antipsychotic or antiepileptic drugs (such as sodium valproate, citalopram, etc.), systemic use of glucocorticoids, etc.;
- Previous bariatric metabolic surgery (except for previous liposuction, abdominal plastic surgery, intragastric balloon extraction or duodenal jejunal cannulation extraction \> 1 year), or planned to receive any surgical treatment during the trial that might affect the evaluation of weight efficacy;
- Past allergy or suspected allergy to GLP-1 receptor agonists, or past allergy to investigational drug ingredients;
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- Participated in any other trial and received at least one treatment in the 90 days prior to screening;
- Thyroid function is unstable or uncontrolled 90 days before screening, or TSH\> 6.0 mIU/L or \< 0.4 mIU/L at screening;
- Previous or family history of medullary thyroid carcinoma or multiple endocrine adenomatosis type 2 (MEN-2) before screening;
- Diagnosis of malignant tumors within 5 years prior to screening (except cured skin basal cell carcinoma or cervical carcinoma in situ);
- Have any of the following major cardiovascular and cerebrovascular history in the 180 days prior to screening: history of myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or heart valve repair, clinically significant and treatment-requiring arrhythmia, unstable angina pectoris, decompensated cardiac insufficiency (NYHA Class III or IV), transient ischemic attack, cerebrovascular accident, etc.;
- Serious gastrointestinal disease (e.g. abnormal gastric emptying, inflammatory bowel disease) before or during screening;
- Patients with moderate to severe depression at the time of screening, or the total score of PHQ-9 at the time of screening ≥15 points; or history of other serious mental illness (e.g., schizophrenia, bipolar disorder); or have a history of suicidal thoughts, attempted suicide or suicidal behavior;
- The presence of any of the following before or during screening: chronic pancreatitis, acute pancreatitis, symptomatic gallbladder disease (except cholecystectomy);
- Any of the following items should be met during screening: (1) systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; (2) QTcF interval of ECG \>450 ms for male or \>470 ms for female; (3) eGFR\< 30 mL/min/1.73 m^2, eGFR is calculated according to CKD-EPI formula; (4) ALT or AST \> 3× upper limit of normal value; (5) blood amylase or blood lipase \> 1.5× the upper limit of normal value; (6) blood triglyceride \> 5.7 mmol/L; (7) calcitonin ≥50ng/L (pg/mL); (8) HIV antibody or HCV antibody or HBsAg positive (except for HBsAg positive but HBV DNA quantitative test results are not higher than the upper limit of the test reference range and no anti-HBV drugs are used during screening);
- A history of drug abuse, drug use or alcohol dependence;
- Total blood donation ≥400 mL or one-time blood loss ≥400 mL within 90 days before screening;
- Fertile female subjects are pregnant or lactating at the time of screening, or had positive HCG blood; or fertile male or female subjects and their partners are unable to use effective contraception during the trial period and within 3 months after the end of treatment;
- Other situations in which the investigator does not consider participation in the study appropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: To Evaluate a Multicenter, Randomized, Open, Positive Parallel Controlled Phase III Clinical Trial of Semaglutide Injection (HD1916) in the Treatment of Obesity
This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.
- Conditions
- Weight Management
- Being tested
- HD1916, semaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD1916Drug
HD1916，0.25mg/0.5mg/1.0mg/1.7mg/2.4mg，SC，once a week
semaglutideDrug
semaglutide ，0.25mg/0.5mg/1.0mg/1.7mg/2.4mg，SC，once a week
| Study group | Role | What they receive |
|---|---|---|
| HD1916 | Experimental | HD1916 will be administered via subcutaneous injection once a week in subjects with obesity. Receives: Drug: HD1916 |
| semaglutide | Active comparator | semaglutide will be administered via subcutaneous injection once a week in subjects with obesity. Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative percentage change in body weight from baseline at 44 weeks of treatment
Measured: Baseline through Week44
Secondary outcomes (6)
Proportion of subjects with a weight loss of ≥5% from baseline at 44 weeks of treatment
Measured: Baseline through Week44
Proportion of subjects with a weight loss of ≥10% from baseline at 44 weeks of treatment
Measured: Baseline through Week44
Changes in waist circumference from baseline at 44 weeks of treatment
Measured: Baseline through Week44
Number of TEAE and SAE cases during the experiment
Measured: Week0 through Week44
Changes in pulse from baseline at 44 weeks of treatment
Measured: Baseline through Week44
Anti-drug antibodies, neutralizing antibodies (anti-drug antibody positive)
Measured: Baseline through Week44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024
- Primary completion27 Aug 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- 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
- Model description
- This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604624
- Sponsor's protocol ID
- HD1916-003
- Status last verified
- Jul 2024
- First submitted
- 12 Sep 2024
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate a Multicenter, Randomized, Open, Positive Parallel Controlled Phase III Clinical Trial of Semaglutide Injection (HD1916) in the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT06604624
- Acronym / sponsor ID
- HD1916-003
- Conditions
- Weight Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 19 Sep 2024 (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 multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a multicenter, randomized, open, positive parallel controlled phase III clinical trial to compare the efficacy and safety of once-weekly HD1916 and semaglutide injection and to evaluate immunogenicity in obese non-diabetic adults.
| Arm | Type | Receives |
|---|---|---|
| HD1916 | Experimental | Drug: HD1916HD1916 will be administered via subcutaneous injection once a week in subjects with obesity. |
| semaglutide | Active comparator | Drug: semaglutidesemaglutide will be administered via subcutaneous injection once a week in subjects with obesity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old (at the time of signing ICF), both male and female;
- BMI≥28 kg/m^2 during screening;
- Within 90 days before screening, the weight change range controlled by diet and exercise alone is less than 5% (see section 1.3 for the calculation formula);
- Voluntarily participate in the trial and sign the informed consent.
Key exclusion criteria (19 listed)
- Meet any of the following requirements: (1) HbA1c≥6.5% or fasting venous blood glucose ≥7.0 mmol/L during screening; (2) a history of type 1 or type 2 or a specific type of diabetes;
- Obesity is caused by drugs or diseases (e.g. Cushing\'s syndrome, acromegaly, etc.); or weight gain caused by increased non-fat content (e.g. edema);
- Received (including) drug therapy with GLP-1 receptor agonists (single target, double target, or multiple target) within 90 days prior to screening;
- Received any other drug or product or treatment within 90 days prior to screening that the investigator determines will affect the assessment of weight efficacy of the trial, including but not limited to drugs or products or treatments that contain overweight/obesity or equivalent meaning in the label indications, hypoglycemic drugs, tricyclic antidepressants, antipsychotic or antiepileptic drugs (such as sodium valproate, citalopram, etc.), systemic use of glucocorticoids, etc.;
- Previous bariatric metabolic surgery (except for previous liposuction, abdominal plastic surgery, intragastric balloon extraction or duodenal jejunal cannulation extraction \> 1 year), or planned to receive any surgical treatment during the trial that might affect the evaluation of weight efficacy;
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 |
|---|---|---|
| HD1916HD1916，0.25mg/0.5mg/1.0mg/1.7mg/2.4mg，SC，once a week | Drug | HD1916 |
| semaglutidesemaglutide ，0.25mg/0.5mg/1.0mg/1.7mg/2.4mg，SC，once a week | Drug | semaglutide |
Primary outcome
Relative percentage change in body weight from baseline at 44 weeks of treatment
Time frame: Baseline through Week44
6 secondary outcomes
Proportion of subjects with a weight loss of ≥5% from baseline at 44 weeks of treatment
Time frame: Baseline through Week44
Proportion of subjects with a weight loss of ≥10% from baseline at 44 weeks of treatment
Time frame: Baseline through Week44
Changes in waist circumference from baseline at 44 weeks of treatment
Time frame: Baseline through Week44
Number of TEAE and SAE cases during the experiment
Time frame: Week0 through Week44
Changes in pulse from baseline at 44 weeks of treatment
Time frame: Baseline through Week44
Anti-drug antibodies, neutralizing antibodies (anti-drug antibody positive)
Time frame: Baseline through Week44
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 HD1916 and semaglutide in people with Weight Management, run by CSPC Baike (Shandong) Biopharmaceutical 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 19 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: finished, as of the sponsor's last update on 6 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative percentage change in body weight from baseline at 44 weeks of treatment (time frame: Baseline through Week44). 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 6 Apr 2026.