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

NCT06849843 | Completed Phase 2

• 1 other identifier: YN011-201
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 10

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. 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. 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. 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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

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

  12 weeks

Secondary Outcomes (10)

• TIR

  12 weeks

• HbA1c<7.0% and <6.5%

  12 weeks

• fasting lipid profiles

  12 weeks

• weight

  12 weeks

• waist circumference

  12 weeks

Study Arms (2)

3mg of Efsubaglutide Alfa QoW

EXPERIMENTAL

Drug: Efsubaglutide Alfa Injection

1mg of Efsubaglutide Alfa QW

ACTIVE COMPARATOR

Drug: Efsubaglutide Alfa Injection

Interventions

Efsubaglutide Alfa Injection DRUG

Efsubaglutide Alfa 3mg/0.5ml

3mg of Efsubaglutide Alfa QoW

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Diabetes other than Type 2;
• Any DPP-4 inhibitors and / or GLP-1 analogues were used within 3 months before screening;
• Continuous use of insulin for more than 14 days in the previous year;
• C-Peptide \<0.3 nmol/L;
• Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non ketonic diabetic coma occurred within 6 months before screening;
• Unstable proliferative retinopathy or macular lesion, severe diabetic neuropathy, intermittent claudication or diabetic foot occurred within 6 months before screening;
• Severe hypoglycemia occurred within 6 months before screening
• Severe trauma infection or operation within one month before screening;
• Blood donation or massive blood loss or transfusion within 3 months ;
• Suspected active infection ;
• Growth hormone therapy was performed within 6 months before screening;
• Patients having received corticosteroid continuous ≥ 7 days through within 2 months ;
• Use any drugs or surgery with weight control effect within 2 months;
• weight change of more than 5% within 3 months;
• 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

Sponsors & Collaborators

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

Study Sites (10)

Nanjing First Hospital

Nanjing, Jiangsu, 210008, China

Location

CangZhou Hospital of Integrated TCM and Western Medicine in Hebei Province

Cangzhou, China

Location

Huzhou Central Hospital

Huzhou, China

Location

Jiangsu Province Offical Hospital

Nanjing, China

Location

Ningbo First Hospital

Ningbo, China

Location

Ningbo Medical Center Lihuili Hospital

Ningbo, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Location

Wenzhou Central Hospital

Wenzhou, China

Location

Zibo Municipal Hospital

Zibo, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 27, 2025
• Study Start: December 18, 2024
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

CN (10)