A Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients.

Phase 2

Recruiting

• Conditions: Type2 Diabetes
• Interventions: Drug: Efsubaglutide Alfa Injection

• Registration Number: NCT06849843
• Lead Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Brief Summary

This is a study to evaluate the impact and efficacy of Efsubaglutide Alfa injection 3mg QoW on the treatment of type 2 diabetes patients with poor glycemic control after dietary and exercise intervention.

Primary objective:

To evaluate the effect and role of continuous treatment with 3mg of Efsubaglutide Alfa QoW and 1mg of Efsubaglutide Alfa QW for 12 weeks on HbA1c in T2DM patients with poor glycemic control after dietary and exercise intervention.

Secondary objectives:

1. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on glucose variability (change in time in range (TIR) relative to baseline) in T2DM patients with poor glycemic control after dietary and exercise intervention.

2. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on drug exposure (relative to 1mg QW) in T2DM patients with poor glycemic control after dietary and exercise intervention.

3. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on fasting plasma glucose (FPG) in T2DM patients with poor glycemic control after dietary and exercise intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-18
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-23
• Study First Posted: 2025-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female patients aged from 18 to 75;
2. Type 2 diabetes diagonsed at least 8 weeks and has not received any glucose-lowering medication within 8 weeks prior to screening;
3. During screening, HbA1c: 7.0% ≤ HbA1c ≤ 11.0%;
4. Before randomization : 7.0% ≤ HbA1c ≤ 11.0%;
5. During screening and before randomization: FPG< 13.9 mmol/L
6. 24 kg/m2 ≤ BMI ≤ 40 kg/m2;
7. Without birth plan and voluntarily take effective contraceptive measures;
8. Fully understood the study, voluntarily entered the study and signed the informed consent.

Exclusion Criteria

1. Diabetes other than Type 2;
2. Any DPP-4 inhibitors and / or GLP-1 analogues were used within 3 months before screening;
3. Continuous use of insulin for more than 14 days in the previous year;
4. C-Peptide <0.3 nmol/L;
5. Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non ketonic diabetic coma occurred within 6 months before screening;
6. Unstable proliferative retinopathy or macular lesion, severe diabetic neuropathy, intermittent claudication or diabetic foot occurred within 6 months before screening;
7. Severe hypoglycemia occurred within 6 months before screening
8. Severe trauma infection or operation within one month before screening;
9. Blood donation or massive blood loss or transfusion within 3 months ;
10. Suspected active infection ;
11. Growth hormone therapy was performed within 6 months before screening;
12. Patients having received corticosteroid continuous ≥ 7 days through within 2 months ;
13. Use any drugs or surgery with weight control effect within 2 months;
14. weight change of more than 5% within 3 months;
15. mean systolic pressure (SBP) ≥ 160mmhg and / or DBP ≥ 90 mmHg at screening, or new/changed antihypertensive drugs or adjusted dosage of antihypertensive drugs within 4 weeks before screening or before induction period
16. with a history of severe cardiovascular disease, high risk of stroke/stroke within 6 months before screening;
17. with a history of acute or chronic pancreatitis, symptomatic gallbladder , pancreatic injury and other risk factors for pancreatitis, or with blood amylase and/or blood lipase ≥1.5 times the upper limit of normal (ULN) at the time of screening or before randomization;
18. Calcitonin level ≥50 ng/L (pg/mL) during screening;
19. with a history of medullary thyroid cancer, multiple endocrine neoplasm (Men) 2A or 2B syndrome, or related family history;
20. with clinically significant abnormal gastric emptying , severe chronic gastrointestinal diseases , long-term use of drugs that have a direct impact on gastrointestinal peristalsis , or having undergone gastrointestinal surgery within 6 months before screening, are not suitable to participate in this clinical study according to the evaluation of the researchers;
21. suffering from hematological diseases or any disease causing hemolysis or erythrocyte instability ;
22. Uncontrolled hyperthyroidism or hypothyroidism;
23. with hemoglobinopathy that may affect the determination of HbA1c levels;
24. HBsAg, HCV-Ab, HIV-Ab, TPAb or COVID-19 nucleic acid tested positive;
25. serious mental illness;
26. drinking more than 14 standard units weekly within 6 months before screening ;
27. a history of organ transplantation or other acquired or congenital immune system diseases;
28. allergic to the active ingredients (GLP-1 and GLP-1 analogues) of the study drug;
29. clear contraindications for the use of metformin;
30. Any of the following conditions: the pacemaker was installed when screened; no pacemaker was installed, but 12 lead ECG showed degree II or III atrioventricular block, long QT syndrome or QTc interval ≥ 450ms (fridericia formula was used to calculate QTCF); Patients with New York Heart Function Classification III or IV; Or other abnormal cardiac function with clinical significance that is not suitable for clinical research judged by researchers;
31. acute or chronic viral hepatitis, or whose laboratory examination indexes meet one of the following criteria at the time of screening or before randomization : alanine aminotransferase (ALT) level ≥ 2.5 fold ULN, aspartate aminotransferase (AST) ≥ 2.5 fold ULN, fasting triglyceride (TG) > 5.7 mmol/L or 500 mg/dl; the glomerular filtration rate (EGFR) < 60 ml/min/1.73 m2 was calculated by CKD-EPI (epi - (SCR)) formula;
32. participated in clinical trials of other drugs or devices within 3 months before screening;
33. Medication compliance in the lead-in period was ≤ 50% ;
34. Any other situation that researchers think may affect the patients' informed consent or compliance with the trial protocol, or the patients' participation in the trial may affect the trial results or their own safety.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3mg of Efsubaglutide Alfa QoW	Efsubaglutide Alfa Injection	-
1mg of Efsubaglutide Alfa QW	Efsubaglutide Alfa Injection	-

Primary Outcome Measures

Name	Time	Method
HbA1c	12 weeks	The change in mean HbA1c concentrations (%)from baseline with Efsubaglutide Alfa 3mg QoW versus Efsubaglutide Alfa 1mg QW

Secondary Outcome Measures

Name	Time	Method
fasting lipid profiles	12 weeks	Changes in fasting lipid(TC/TG/HDL-C/LDL-C) profiles relative to baseline(mmol/L)
weight	12 weeks	Weight change from baseline(kg)
TIR	12 weeks	Changes in the percentage of time in range (TIR) relative to baseline
hip circumference	12 weeks	Absolute changes in hip circumference(cm) from baseline
waist-to-hip ratio (WHR)	12 weeks	Absolute changes in waist-to-hip ratio (WHR) from baseline
salvage treatment	12 weeks	Percentage of subjects receiving salvage treatment(%)
HbA1c<7.0% and <6.5%	12 weeks	The proportion of participants who achieved HbA1c target (HbA1c\<7.0% and \<6.5% Patient percentage)
waist circumference	12 weeks	Absolute changes in waist circumference(cm) from baseline
body fat composition	12 weeks	Changes in body fat composition from baseline
FPG	12 weeks	Changes in FPG (mmol/L) relative to baseline

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China