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

A Multicenter, Randomized, Controlled Clinical Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients With Poor Glycemic Control After Diet and Exercise Intervention.

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Drug: Efsubaglutide Alfa Injection; Drug: Efsubaglutide Alfa Injection

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Cangzhou, China
    • CangZhou Hospital of Integrated TCM and Western Medicine in Hebei Province
  • Huzhou, China
    • Huzhou Central Hospital
  • Nanjing, China
    • Jiangsu Province Offical Hospital
  • Ningbo, China
    • Ningbo First Hospital
  • Ningbo, China
    • Ningbo medical center lihuili hospital
  • Suzhou, China
    • The First Affiliated Hospital of Soochow University
  • Wenzhou, China
    • The Second Affiliated Hospital of Wenzhou Medical University
  • Wenzhou, China
    • Wenzhou Central Hospital
  • Zibo, China
    • Zibo Municipal Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3mg of Efsubaglutide Alfa QoW	Drug: Efsubaglutide Alfa Injection; Efsubaglutide Alfa 3mg/0.5ml; Drug: Efsubaglutide Alfa Injection; Efsubaglutide Alfa 1mg/0.5ml
Active Comparator: 1mg of Efsubaglutide Alfa QW	Drug: Efsubaglutide Alfa Injection; Efsubaglutide Alfa 3mg/0.5ml; Drug: Efsubaglutide Alfa Injection; Efsubaglutide Alfa 1mg/0.5ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	The change in mean HbA1c concentrations (%)from baseline with Efsubaglutide Alfa 3mg QoW versus Efsubaglutide Alfa 1mg QW	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: YN011-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No