Type 2 Diabetes (T2DM)Phase 3NCT07046273
Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes
A Phase 3 study testing F027 and Ozempic® in people with Type 2 Diabetes (T2DM), run by Shandong New Time Pharmaceutical Co., LTD.
Trial summary
This study is a multicenter, randomized, open, parallel-controlled, Phase III clinical study aimed to evaluate the efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- What is being tested?
- F027 and Ozempic®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Feb 2029
- 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
- 1) Voluntary signing of informed consent; 2) Aged 18-75 years (inclusive) at the time of signing the informed consent, male or female; 3) Diagnosed with type 2 diabetes according to the WHO diabetes diagnostic criteria; 4) Laboratory tests at the research center at screening: 7.5%≤HbA1c≤10.5%; 5) Before randomization, study participants received stable doses of metformin (≥1500mg/day or maximum tolerated dose: <1500mg/day, but ≥1000mg/day) for at least 8 weeks (maximum tolerated dose must be supported by previous medical records); 6) Body mass index (BMI) ≥18.5kg/m2 and ≤35.0kg/m2 at screening; 7) Willing and able to undergo treatment and follow-up as required by the protocol.
Who cannot join
- Type 1 diabetes, special type of diabetes;
- Received hypoglycemic drugs other than metformin (including Chinese medicine) within 8 weeks before randomization;
- Used non-diabetes treatment drugs that may have a significant impact on glucose metabolism for 1 week or more within 3 months before randomization, such as glucocorticoids (systemic glucocorticoids used for <7 days, excluding inhalation, ocular medication or topical application), sympathetic nerve stimulants (such as isoproterenol, dopamine, atropine, etc.), growth hormone, high-dose salicylates (300 mg/day and above), danazol, octreotide and anabolic androgenic steroids (such as oxymetholone, oxandrolone, etc.);
- Has a history of ≥2 episodes of grade 3 hypoglycemia within 1 year before randomization;
- Diabetic ketoacidosis or hyperglycemic hyperosmolar state within 3 months before randomization;
- Severe complications of diabetes at screening: such as proliferative diabetic retinopathy, macular edema; history of renal transplantation; severe peripheral vascular disease (such as amputation, chronic foot ulcers, intermittent claudication);
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- Untreated or poorly controlled hypertension (defined as systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) at screening/randomization;
- Cardiovascular diseases such as acute coronary syndrome (including but not limited to acute myocardial infarction, or unstable angina), arrhythmia requiring treatment, severe heart failure (refer to New York Heart Association heart function grade III or IV), coronary artery bypass grafting or coronary stent implantation within 6 months before screening;
- New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke and transient ischemic attack, etc.) within 6 months before screening;
- Severe trauma or severe infection or surgery that may affect blood sugar control within 1 month before screening;
- History of acute or chronic pancreatitis;
- History of cholecystitis due to cholelithiasis or other reasons within 6 months before screening;
- Cushing's syndrome, hyperthyroidism, and uncontrolled hypothyroidism at screening;
- Significant gastric emptying abnormalities (such as gastric outlet obstruction) and severe gastrointestinal diseases at screening;
- Any disease that may cause hemolysis or red blood cell instability and affect HbA1c detection, such as blood system tumors, hemolytic anemia, sickle cell disease;
- History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
- History of malignant tumors in the past 5 years (regardless of organ system, whether treated or not, and whether there is evidence of recurrence or metastasis) or currently being evaluated for potential malignant tumors, but excluding clinically cured cervical carcinoma in situ and skin basal cell carcinoma;
- Meet any of the following criteria at screening:
- Liver function impairment: ALT or AST ≥ 5 times the upper limit of normal, or total bilirubin ≥ 2 times the upper limit of normal; Renal function impairment: glomerular filtration rate (eGFR, CKD-EPI formula) < 45mL/min/1.73m2; Fasting triglyceride (TG) ≥ 5.7mmol/L after stable medication; Calcitonin ≥ 50ng/L; Hemoglobin ≤ 100g/L; Thyrotropin (TSH) > 6mIU/L after stable medication; Blood amylase or lipase ≥ 3 times the upper limit of normal; Hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis serological test results are positive, hepatitis B virus surface antigen is positive and HBV-DNA is positive.
- Known allergy to any component of semaglutide injection or allergy to other GLP-1 RA drugs;
- Donated blood or lost ≥400mL of blood within 3 months before screening, or received blood transfusion therapy, or planned to donate blood during the trial;
- Received other clinical research drugs or device treatments within 3 months before screening, or participated in other drug clinical trials and are still within 5 half-lives of the trial drug, whichever is older; or planned to participate in other clinical studies during the trial;
- Have a history of drug abuse (including drug abuse) and/or alcohol dependence within 6 months before screening;
- Mental disorder or language barrier, unable to fully understand and cooperate;
- Pregnant or lactating women;
- Male and female research participants who have fertility plans during the trial and within 2 months after the last dose of the trial drug, or are unwilling to take reliable contraceptive measures for contraception;
- Other situations that the researcher considers unsuitable for participation in this study. -
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, Open, Parallel-controlled, Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes
This study is a multicenter, randomized, open, parallel-controlled, Phase III clinical study aimed to evaluate the efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes (T2DM)
- Being tested
- F027, Ozempic®
- 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.
F027Drug
The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
Ozempic®Drug
The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| F027 | Experimental | The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks. Receives: Drug: F027 |
| Ozempic® | Active comparator | The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks. Receives: Drug: Ozempic® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline
Measured: Week 32
Secondary outcomes (9)
Change in HbA1c from baseline
Measured: Week 20
Percentage of Participants Who Achieved HbA1c <6.5%
Measured: Week 32
Percentage of participants who achieved HbA1c < 7.0%
Measured: Week 32
Change in Fasting Glucose
Measured: Week 20 ,32
Change in Body Weight
Measured: Week 32
Collect the incidence of adverse events (AEs)/serious adverse events (SAEs) through vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, etc.
Measured: Week 32
Incidence of hypoglycemic events and acute pancreatitis
Measured: Week 32
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (Nab)
Measured: Week 32
Semaglutide steady-state trough concentration (Css, min)
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046273
- Sponsor's protocol ID
- NTP-F027-002
- Status last verified
- Mar 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open, Parallel-controlled, Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07046273
- Acronym / sponsor ID
- NTP-F027-002
- Conditions
- Type 2 Diabetes (T2DM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 1 Jul 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, open, parallel-controlled, Phase III clinical study aimed to evaluate the efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F027 | Experimental | Drug: F027The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks. |
| Ozempic® | Active comparator | Drug: Ozempic®The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Voluntary signing of informed consent; 2) Aged 18-75 years (inclusive) at the time of signing the informed consent, male or female; 3) Diagnosed with type 2 diabetes according to the WHO diabetes diagnostic criteria; 4) Laboratory tests at the research center at screening: 7.5%≤HbA1c≤10.5%; 5) Before randomization, study participants received stable doses of metformin (≥1500mg/day or maximum tolerated dose: <1500mg/day, but ≥1000mg/day) for at least 8 weeks (maximum tolerated dose must be supported by previous medical records); 6) Body mass index (BMI) ≥18.5kg/m2 and ≤35.0kg/m2 at screening; 7) Willing and able to undergo treatment and follow-up as required by the protocol.
Key exclusion criteria (27 listed)
- Type 1 diabetes, special type of diabetes;
- Received hypoglycemic drugs other than metformin (including Chinese medicine) within 8 weeks before randomization;
- Used non-diabetes treatment drugs that may have a significant impact on glucose metabolism for 1 week or more within 3 months before randomization, such as glucocorticoids (systemic glucocorticoids used for <7 days, excluding inhalation, ocular medication or topical application), sympathetic nerve stimulants (such as isoproterenol, dopamine, atropine, etc.), growth hormone, high-dose salicylates (300 mg/day and above), danazol, octreotide and anabolic androgenic steroids (such as oxymetholone, oxandrolone, etc.);
- Has a history of ≥2 episodes of grade 3 hypoglycemia within 1 year before randomization;
- Diabetic ketoacidosis or hyperglycemic hyperosmolar state within 3 months before randomization;
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 |
|---|---|---|
| F027The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks. | Drug | F027 |
| Ozempic®The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks. | Drug | Ozempic® |
Primary outcome
Change in HbA1c from baseline
Time frame: Week 32
9 secondary outcomes
Change in HbA1c from baseline
Time frame: Week 20
Percentage of Participants Who Achieved HbA1c <6.5%
Time frame: Week 32
Percentage of participants who achieved HbA1c < 7.0%
Time frame: Week 32
Change in Fasting Glucose
Time frame: Week 20 ,32
Change in Body Weight
Time frame: Week 32
Collect the incidence of adverse events (AEs)/serious adverse events (SAEs) through vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, etc.
Time frame: Week 32
Incidence of hypoglycemic events and acute pancreatitis
Time frame: Week 32
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (Nab)
Time frame: Week 32
Semaglutide steady-state trough concentration (Css, min)
Time frame: Week 32
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 1 Jul 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 F027 and Ozempic® in people with Type 2 Diabetes (T2DM), run by Shandong New Time 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 1 inclusion and 27 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 1 Jul 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. 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 Jian xiang Zhang (0539-8330397, jianxiangzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline (time frame: Week 32). 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 1 Jul 2025.