Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes

NCT07046273 | Not Yet Recruiting Phase 3

• 1 other identifier: NTP-F027-002
• Study Type: interventional
• Target: 496
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes (T2DM)

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline

  Week 32

Secondary Outcomes (9)

• Change in HbA1c from baseline

  Week 20

• Percentage of Participants Who Achieved HbA1c <6.5%

  Week 32

• Percentage of participants who achieved HbA1c < 7.0%

  Week 32

• Change in Fasting Glucose

  Week 20 ,32

• Change in Body Weight

  Week 32

Study Arms (2)

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.

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.

Drug: Ozempic®

Interventions

F027 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.

F027

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.

Ozempic®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jian xiang Zhang

CONTACT

0539-8330397; jianxiangzhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 1, 2025

Record last verified: 2025-03