Comparison of semaglutide and Ozempic injections in healthy adults

A Randomized, Open-label, Single-dose, Parallel-controlled Phase I Clinical Trial Comparing the Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.

This study is testing if a new injection called semaglutide is as safe and works the same way in the body as Ozempic in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06634927 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics, safety, and immunogenicity of semaglutide injection compared to Ozempic® injection in healthy adult participants. It is a randomized, open-label, single-dose, parallel-controlled study where eligible subjects will receive either semaglutide or Ozempic® via subcutaneous injection. Participants will be monitored for a total of 7 weeks, including a follow-up period of 5 weeks after administration. The aim is to determine if the investigational drug is similar to the active comparator in terms of how it is processed in the body and its safety profile.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy men and women aged 18 to 55 with a BMI between 19.0 and 25.0 kg/m2.

Not a fit: Patients with a history of serious diseases or significant health conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and efficacy of a new biosimilar treatment option for patients with Type 2 Diabetes.

How similar studies have performed: Other studies have shown success with similar biosimilar comparisons, indicating a promising approach in this area.

Eligibility criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be enrolled in the study:

1. Voluntarily participate in the trial and sign the informed consent; Willing and able, in the investigator\'s judgment, to comply with all experimental requirements and restrictions;
2. Healthy men and women, aged 18 to 55 years old (including);
3. Body mass index (BMI) 19.0\~25.0 kg/m2 (including), weight ≥50.0 kg;
4. Physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory examination, no clinically significant abnormalities;

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded:

1. Have a history of clinically serious disease or currently have any clinically significant cardiovascular, metabolic, endocrine, kidney, liver, gastrointestinal, hematological, respiratory, cutaneous, neurological, gynecological, psychiatric or other disease;
2. A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2A or 2B syndrome, or related family history; Or other malignant tumor history;
3. Subjects with a history of acute and chronic pancreatitis, symptomatic gallbladder history, pancreatic injury history and other high-risk factors that may lead to pancreatitis;
4. In the screening period, calcitonin was greater than the upper limit of normal;
5. Patients with HbA1c greater than 6.5% during the screening period;
6. Those who smoked more than 5 cigarettes per day in the 3 months before screening and those who could not smoke during the whole test period;
7. Those who have a history of alcohol abuse in the six months prior to screening, or who cannot abstain from alcohol during the test period;
8. Consume any food or drink containing caffeine, alcohol, xanthine or grapefruit (such as coffee, strong tea, chocolate, etc.) within 48 hours before check-in;
9. Known or suspected allergy to semaglutide injection or similar products and excipients;
10. Participants in clinical trials of any approved or unapproved investigational drug/device within 90 days prior to screening;
11. Pregnant and lactating female subjects;
12. Patients with difficulty in venous blood collection;
13. Those who were vaccinated within 4 weeks prior to screening or planned to be vaccinated during the trial;
14. People who donate blood or lose more than 400 mL of blood or receive blood transfusions or use blood products in the 3 months prior to screening;
15. Patients who have previously received Semaglutide injection or other GLP-1 or GLP-1/ GIP-like treatment;
16. Those who have a history of drug abuse or test positive for drug abuse screening;
17. Those who test positive for blood alcohol;
18. For any other reason, the investigator does not consider the volunteer to be suitable for participation in this clinical trial.

Where this trial is running

Hefei, Anhui

• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Weizhi Gu

Conditions Type 2 Diabetes; Glucagon-Like Peptide-1 Receptor Agonists; semaglutide