Type2 DiabetesPhase 2NCT06849843

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

A Phase 2 study testing Efsubaglutide Alfa Injection in people with Type2 Diabetes, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type2 Diabetes
What is being tested?: Efsubaglutide Alfa Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 10 sitesChina
Study dates: 18 Dec 2024to 29 May 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
24 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.

Who cannot join

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;

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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
with a history of severe cardiovascular disease, high risk of stroke/stroke within 6 months before screening;
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;
Calcitonin level ≥50 ng/L (pg/mL) during screening;
with a history of medullary thyroid cancer, multiple endocrine neoplasm (Men) 2A or 2B syndrome, or related family history;
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;
suffering from hematological diseases or any disease causing hemolysis or erythrocyte instability ;
Uncontrolled hyperthyroidism or hypothyroidism;
with hemoglobinopathy that may affect the determination of HbA1c levels;
HBsAg, HCV-Ab, HIV-Ab, TPAb or COVID-19 nucleic acid tested positive;
serious mental illness;
drinking more than 14 standard units weekly within 6 months before screening ;
a history of organ transplantation or other acquired or congenital immune system diseases;
allergic to the active ingredients (GLP-1 and GLP-1 analogues) of the study drug;
clear contraindications for the use of metformin;
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;
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;
participated in clinical trials of other drugs or devices within 3 months before screening;
Medication compliance in the lead-in period was ≤ 50% ;
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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

CangZhou Hospital of Integrated TCM and Western Medicine in Hebei Province
Cangzhou
Huzhou Central Hospital
Huzhou
Nanjing First Hospital
Nanjing, Jiangsu, 210008
Jiangsu Province Offical Hospital
Nanjing
Ningbo First Hospital
Ningbo
Ningbo Medical Center Lihuili Hospital
Ningbo
The First Affiliated Hospital of Soochow University
Suzhou
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou
Wenzhou Central Hospital
Wenzhou
Zibo Municipal Hospital
Zibo

Other trials in China

About this study

Official title: 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.

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:

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.
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.
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
Being tested: Efsubaglutide Alfa Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Efsubaglutide Alfa InjectionDrug
Efsubaglutide Alfa 3mg/0.5ml
Efsubaglutide Alfa InjectionDrug
Efsubaglutide Alfa 1mg/0.5ml

Study groups in NCT06849843
Study group	Role	What they receive
3mg of Efsubaglutide Alfa QoW	Experimental	Not described Receives: Drug: Efsubaglutide Alfa Injection
1mg of Efsubaglutide Alfa QW	Active comparator	Not described Receives: Drug: Efsubaglutide Alfa Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 202429 May 2025

First posted27 Feb 2025
Study start18 Dec 2024
Primary completion29 May 2025
Study completion29 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06849843
Sponsor's protocol ID: YN011-201
Status last verified: Sep 2025
First submitted: 13 Feb 2025
Last updated: 12 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT06849843
Acronym / sponsor ID: YN011-201
Conditions: Type2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.University, hospital or other
Study start: 18 Dec 2024 (actual)
Primary completion: 29 May 2025 (actual)
Study completion: 29 May 2025 (actual)
First posted: 27 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objective:

Secondary objectives:

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.
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.
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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
3mg of Efsubaglutide Alfa QoW	Experimental	Drug: Efsubaglutide Alfa Injection
1mg of Efsubaglutide Alfa QW	Active comparator	Drug: Efsubaglutide Alfa Injection

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (34 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Efsubaglutide Alfa InjectionEfsubaglutide Alfa 3mg/0.5ml	Drug	3mg of Efsubaglutide Alfa QoW
Efsubaglutide Alfa InjectionEfsubaglutide Alfa 1mg/0.5ml	Drug	1mg of Efsubaglutide Alfa QW

Primary outcome

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

10 secondary outcomes

TIR
Time frame: 12 weeks
HbA1c<7.0% and <6.5%
Time frame: 12 weeks
fasting lipid profiles
Time frame: 12 weeks
weight
Time frame: 12 weeks
waist circumference
Time frame: 12 weeks
hip circumference
Time frame: 12 weeks
waist-to-hip ratio (WHR)
Time frame: 12 weeks
salvage treatment
Time frame: 12 weeks
body fat composition
Time frame: 12 weeks
FPG
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.

Related trials for Type2 Diabetes

Recruiting
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Heart Failure, Diabetes
Recruiting
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Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
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An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
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Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Efsubaglutide Alfa Injection in people with Type2 Diabetes, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06849843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.