Obesity and OverweightPhase 2NCT07114419
The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE）
A Phase 2 study testing Efsubaglutide Alfa 20 mg QW, Efsubaglutide Alfa 40 mg QW and Efsubaglutide Alfa 40 mg Q2W in people with Obesity and Overweight, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 5 sites in Australia.
Trial summary
This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI < 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Efsubaglutide Alfa 20 mg QW, Efsubaglutide Alfa 40 mg QW and Efsubaglutide Alfa 40 mg Q2W
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesAustralia
- Study dates
- 25 Aug 2025to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent form (ICF);
- Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing the ICF;
- Obese: BMI ≥ 30.0 kg/m2, with or without comorbidities; Or overweight: 27.0 kg/m2 ≤ BMI < 30.0 kg/m2, with at least one of the following weight-related comorbidities: pre-diabetes, hypertension, dyslipidemia, fatty liver, osteoarthritis, or obesity-induced obstructive sleep apnea syndrome (If the subject has only fatty liver as a comorbidity, imaging results within the 3 months prior to screening are required for fatty liver);
- A self-reported change in body weight less than 5.0% controlled with diet and exercise within 3 months before screening;
- Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception methods throughout the study (from the signing of ICF to 3 months after the last dose of investigational medicinal products).
Who cannot join
- Obesity caused by endocrine disease or monogenic mutation, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma, acromegaly or hypogonadism;
- Known or suspected allergy to the investigational medicinal product, its components or drugs of the same class;
- Previously diagnosed diabetes mellitus (including type 1 diabetes mellitus, type 2 diabetes mellitus, diabetes mellitus due to pancreatic damage, or other types of diabetes mellitus [except gestational diabetes mellitus]);
- History of severe gastrointestinal disease (e.g., active ulcers), or gastrointestinal surgery (except for appendectomy, cholecystectomy, or other gastrointestinal endoscopic surgeries deemed by the investigator to have no significant impact on gastrointestinal motility), or clinically significant gastric emptying abnormalities (e.g., pyloric obstruction, gastroparesis), or long-term use of drugs with direct effects on gastrointestinal motility within 6 months before screening, or those who were not suitable for participating in this study at the investigator's discretion;
- History of significant cardiovascular or cerebrovascular disease within 6 months before screening, including but not limited to:1) Myocardial infarction, coronary angioplasty or bypass grafting, heart valve disease or heart valve repair, clinically significant arrhythmias requiring treatment, angina, transient ischemic attack, cerebrovascular accident or others; 2)Congestive heart failure classified as Grade III or IV by the New York Heart Association (NYHA) (refer to Appendix 3);
- History of acute or chronic pancreatitis, symptomatic gallbladder disease (subjects who have undergone cholecystectomy and have stable condition post-surgery are excluded), or pancreatic injury and other factors that may lead to high risk of pancreatitis;
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- Presence of hyperthyroidism; or hypothyroidism that has not been controlled with a stable medication dose (defined as a stable dose for 3 months or longer);
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
- Subjects who have experienced two or more hypoglycemic events within 6 months prior to screening, defined as blood glucose < 2.8 mmol/L (50.4 mg/dl) or blood glucose not reaching < 2.8 mmol/L (50.4 mg/dl) but with significant hypoglycemia symptoms (manifested by sympathetic arousal [e.g., palpitations, anxiety, sweating, dizziness, shaking of the hands, feeling of hunger, etc.] and CNS symptoms [e.g., altered mentation, cognitive disturbances, seizures and coma]);
- History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years; or there is a potential malignancy during screening;
- History of severe infection or severe trauma within 3 months prior to screening, or undergoing major surgery or not fully recovering from surgery, and the investigator determines that the participant is unsuitable for this study;
- History of significant active or unstable major depressive disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within 2 years prior to screening;
- Previous suicidal tendency or suicidal behavior;
- Suicidal ideation corresponding to type 4 or 5 on the C-SSRS at screening;
- PHQ-9 questionnaire ≥ 15 points at screening;
- Known active infections, e.g., bacterial, fungal and viral infections, including: 1)Human immunodeficiency virus (HIV) infection: defined as HIV antibody positive; 2)Syphilis infection: defined as treponema pallidum antibody (TP-Ab) positive; 3)Active hepatitis B virus (HBV): defined as hepatitis B surface antigen (HBsAg) positive and HBV-deoxyribonucleic acid (DNA) ≥ lab-specific upper limit of normal (ULN) (for those with positive result on HBsAg, HBV DNA test will be performed and those with positive HBV DNA results will be excluded); 4)Active hepatitis C virus (HCV): defined as HCV antibody (HCV-Ab) positive and HCV-ribonucleic acid (RNA) positive, if HCV-Ab positive and HCV RNA negative can be considered as eligible at the discretion of the Investigator;
- Any of the laboratory test results at screening meet the following criteria (if there is a clear reason for re-test, the re-test can be performed once during the screening period, and the investigator should record the reason for re-test): 1)HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L (126 mg/dL) (fasting blood glucose will be tested at the local laboratory at the time of screening, plasma or serum glucose is acceptable); 2)Thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L; 3)ALT or AST ≥ 3.0×ULN or total bilirubin (TBIL) ≥ 2× ULN; 4)Fasting TG > 5.65 mmol/L (500 mg/dl); 5)Blood amylase or lipase > 2.0×ULN; 6)Calcitonin ≥ 50 ng/L(pg/mL); 7)Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2, calculated by the CKD-EPI formula (refer to Appendix 4); 8)International normalized ratio (INR) > ULN;
- Abnormal 12-lead ECG: second- or third-degree atrioventricular block, long QT syndrome or QTcF > 450 ms (males) or > 470 ms (females) (refer to Appendix 5), left bundle branch block, Wolff-Parkinson-White syndrome, or other clinically significant abnormalities that require treatment;
- Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
- Use of any of the following medications or treatments within 3 months prior to screening: 1)Weight loss drugs, such as semaglutide, sibutramine hydrochloride, orlistat, phentermine, phenylpropanolamine, chlorpheniramine, phentermine, bupropion, lorcaserin, phentermine/topiramate mixture, naltrexone/bupropion mixture, etc.; 2)Chinese herbal medicine, health products, meal replacements affecting body weight; 3)Glucose-lowering drugs, such as metformin, SGLT2 inhibitors, GLP-1R agonists, thiazolidinediones (TZDs), etc; 4)Drugs that may affect body weight, including systemic steroids (Consecutively for 7 or more days), tricyclic antidepressants, psychiatric drugs or sedative drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts);
- Previous bariatric surgery; acupuncture/cupping for weight loss, liposuction, and abdominal liposuction within 1 year prior to screening; or plan to undergo corresponding treatment during the study period;
- Subjects who have participated in other clinical studies and received investigational drug therapy, vaccines or medical device intervention within 3 months before screening;
- Blood donation or blood loss ≥ 400 mL within 3 months before screening, or those who have received blood transfusion;
- Inability to be venipunctured and/or tolerate venous access;
- Alcohol consumption of > 21 units per week for males and > 14 units per week for females within the 6 months before screening (1 unit=360 mL of beer or 45 mL of spirits with an alcohol content of ≥ 40% or 150 mL of wine);
- Have a history or suspected abuse of drug, and the investigator determines that the subject is unsuitable for this study;
- Have history of use of marijuana within 3 months before screening and unwillingness to abstain from marijuana use during the study;
- Pregnant or lactating women;
- Other conditions deemed unsuitable for participation in this study according to the judgment of the investigator..
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
Canopy Clinical Northern Beaches
Brookvale
Deon Smith
- Recruiting
Canopy Clinical Sutherland Shire
Miranda
Kaluhin Karen
- Recruiting
Canopy Clinical Altona North
North Altona
Oscar Walsh
- Recruiting
Fusion Clinical Research
Norwood
Tom Poleasek
- Recruiting
Canopy Clinical Wollongong
Wollongong
Tess Tonkin
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Efsubaglutide Alfa Injection in Subjects With Overweight or Obesity
This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI < 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). The entire study period will consist of a 2-week screening period, a 22-week double-blind treatment period, and a 4-week off-treatment follow-up period
- Conditions
- Obesity and Overweight
- Being tested
- Efsubaglutide Alfa 20 mg QW, Efsubaglutide Alfa 40 mg QW, Efsubaglutide Alfa 40 mg Q2W, Efsubaglutide Alfa 80 mg QW, Efsubaglutide Alfa 80 mg Q4W
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efsubaglutide Alfa 20 mg QWDrug
Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa 40 mg QWDrug
Efsubaglutide Alfa 40 mg QW
Efsubaglutide Alfa 40 mg Q2WDrug
Efsubaglutide Alfa 40 mg Q2W
Efsubaglutide Alfa 80 mg QWDrug
Efsubaglutide Alfa 80 mg QW
Efsubaglutide Alfa 80 mg Q4WDrug
Efsubaglutide Alfa 80 mg Q4W
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Efsubaglutide 20 mg Quaque Week (QW） | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, reaching the target dose of 20 mg, the total treatment last for 22weeks. Receives: Drug: Efsubaglutide Alfa 20 mg QW; Other: Placebo |
| Efsubaglutide 40 mg QW | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg, reaching the target dose of 40 mg, the total treatment last for 22weeks. Receives: Drug: Efsubaglutide Alfa 40 mg QW; Other: Placebo |
| Efsubaglutide Alfa 40 mg Q2W | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg,when reaching to target dose of 40 mg, administered the drug every 2weeks. the total treatment last for 22weeks. Receives: Drug: Efsubaglutide Alfa 40 mg Q2W; Other: Placebo |
| Efsubaglutide Alfa 80 mg QW | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg, reaching the target dose of 80 mg, the total treatment last for 22weeks. Receives: Drug: Efsubaglutide Alfa 80 mg QW; Other: Placebo |
| Efsubaglutide Alfa 80 mg Q4W | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg,when reaching to target dose of 80 mg, administered the drug every 4weeks. the total treatment last for 22weeks. Receives: Drug: Efsubaglutide Alfa 80 mg Q4W; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change (%) of body weight from baseline after subcutaneous administration of YN-011 for 22 weeks
Measured: 22 weeks
Secondary outcomes (24)
Proportion of subjects with body weight loss ≥ 5%, ≥ 10%, and ≥ 15% from baseline after subcutaneous
Measured: 22 weeks
Absolute change from baseline in body weight (Kg) after subcutaneous administration for 22 weeks
Measured: 22 weeks
Changes from baseline in BMI after subcutaneous administration for 22 weeks
Measured: 22 weeks
Changes from baseline in waist to hip circumference ratio after subcutaneous administration for 22 weeks
waist circumference, hip circumference,
Measured: 22 weeks
Changes from baseline in waist to height ratio after subcutaneous administration of YN-011 for 22 weeks
Measured: 22 weeks
Changes from baseline in systolic and diastolic blood pressure after subcutaneous administration for 22 weeks
Measured: 22 weeks
Changes from baseline in blood lipids (including TC, TG, LDL-C, and high-density lipoprotein cholesterol [HDL-C]) after subcutaneous administration for 22 weeks, percentage change from baseline, and ratio to baseline
Measured: 22 weeks
Changes from baseline in glycated hemoglobin (HbA1c) after administration subcutaneous for 22 weeks
Measured: 22 weeks
Changes from baseline in fasting plasma glucose(FPG) after subcutaneous administration of YN-011 for 22 weeks;
Measured: 22 weeks
Changes from baseline in fasting insulin after subcutaneous administration of YN-011 for 22 weeks;
insulin resistance by HOMA-IR, β-cell function by HOMA-β,
Measured: 22 weeks
Changes from baseline in blood uric acid after subcutaneous administration for 22 weeks, percentage change from baseline, and ratio to baseline
Measured: 22 weeks
Safety assessment will be conducted throught the study by Incidence of adverse events (AEs) and serious adverse events (SAEs);
Measured: 22 weeks
Safety assessment will be conducted throught the study by Mental health status via Patient Health Questionnaire-9 (PHQ-9)
Measured: 26 weeks
Safety assessment will be conducted throught the study by Mental health status via Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: 26 weeks
Maximum plasma concentration (Cmax) of YN-011 via subcutaneous administration through the study
Measured: 22 weeks
Timepoint of maximum plasma concentration (Tmax) of YN-011 via subcutaneous administration
Measured: 22 weeks
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t) of YN-011 via subcutaneous administration
Measured: 22 weeks
Elimination half-life (t1/2) of YN-011 via subcutaneous administration
Measured: 22 weeks
Apparent clearance (CL/F) of YN-011 via subcutaneous administration
Measured: 22 weeks
Apparent volume of distribution (Vz/F) of YN-011 via subcutaneous administration
Measured: 22 weeks
Trough concentration (Ctrough) of YN-011 via subcutaneous administration
Measured: 22 weeks
Incidence of anti-drug antibody (ADA) against YN-011 in serum before and after subcutaneous administration
Measured: 22 weeks
Incidence of neutralizing antibody (NAb) against YN-011 in serum before and after subcutaneous administration
NAb will be tested when ADA result is positive
Measured: 22 weeks
Changes from baseline in Dual Energy X-ray Absorptiometry [DEXA] data report (DEXA data inculding total fat mass, muscle mass, regional visceral fat mass and total lean body mass) after subcutaneous administration of YN-011
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start25 Aug 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Kaluhin, Principal investigator, Canopy Clinical Sutherland Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114419
- Sponsor's protocol ID
- YN012-II-W204-AU
- Other IDs
- YN012-II-W204-AU
- Status last verified
- Nov 2025
- First submitted
- 6 Jul 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Efsubaglutide Alfa Injection in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07114419
- Acronym / sponsor ID
- YN012-II-W204-AU
- Conditions
- Obesity and Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.University, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 11 Aug 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.
This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI < 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). The entire study period will consist of a 2-week screening period, a 22-week double-blind treatment period, and a 4-week off-treatment follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Efsubaglutide 20 mg Quaque Week (QW） | Experimental | Drug: Efsubaglutide Alfa 20 mg QW, Other: PlaceboThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, reaching the target dose of 20 mg, the total treatment last for 22weeks. |
| Efsubaglutide 40 mg QW | Experimental | Drug: Efsubaglutide Alfa 40 mg QW, Other: PlaceboThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg, reaching the target dose of 40 mg, the total treatment last for 22weeks. |
| Efsubaglutide Alfa 40 mg Q2W | Experimental | Drug: Efsubaglutide Alfa 40 mg Q2W, Other: PlaceboThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg,when reaching to target dose of 40 mg, administered the drug every 2weeks. the total treatment last for 22weeks. |
| Efsubaglutide Alfa 80 mg QW | Experimental | Drug: Efsubaglutide Alfa 80 mg QW, Other: PlaceboThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg, reaching the target dose of 80 mg, the total treatment last for 22weeks. |
| Efsubaglutide Alfa 80 mg Q4W | Experimental | Drug: Efsubaglutide Alfa 80 mg Q4W, Other: PlaceboThe drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg,when reaching to target dose of 80 mg, administered the drug every 4weeks. the total treatment last for 22weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent form (ICF);
- Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing the ICF;
- Obese: BMI ≥ 30.0 kg/m2, with or without comorbidities; Or overweight: 27.0 kg/m2 ≤ BMI < 30.0 kg/m2, with at least one of the following weight-related comorbidities: pre-diabetes, hypertension, dyslipidemia, fatty liver, osteoarthritis, or obesity-induced obstructive sleep apnea syndrome (If the subject has only fatty liver as a comorbidity, imaging results within the 3 months prior to screening are required for fatty liver);
- A self-reported change in body weight less than 5.0% controlled with diet and exercise within 3 months before screening;
- Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception methods throughout the study (from the signing of ICF to 3 months after the last dose of investigational medicinal products).
Key exclusion criteria (29 listed)
- Obesity caused by endocrine disease or monogenic mutation, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma, acromegaly or hypogonadism;
- Known or suspected allergy to the investigational medicinal product, its components or drugs of the same class;
- Previously diagnosed diabetes mellitus (including type 1 diabetes mellitus, type 2 diabetes mellitus, diabetes mellitus due to pancreatic damage, or other types of diabetes mellitus [except gestational diabetes mellitus]);
- History of severe gastrointestinal disease (e.g., active ulcers), or gastrointestinal surgery (except for appendectomy, cholecystectomy, or other gastrointestinal endoscopic surgeries deemed by the investigator to have no significant impact on gastrointestinal motility), or clinically significant gastric emptying abnormalities (e.g., pyloric obstruction, gastroparesis), or long-term use of drugs with direct effects on gastrointestinal motility within 6 months before screening, or those who were not suitable for participating in this study at the investigator's discretion;
- History of significant cardiovascular or cerebrovascular disease within 6 months before screening, including but not limited to:1) Myocardial infarction, coronary angioplasty or bypass grafting, heart valve disease or heart valve repair, clinically significant arrhythmias requiring treatment, angina, transient ischemic attack, cerebrovascular accident or others; 2)Congestive heart failure classified as Grade III or IV by the New York Heart Association (NYHA) (refer to Appendix 3);
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 20 mg QWEfsubaglutide Alfa 20 mg QW | Drug | Efsubaglutide 20 mg Quaque Week (QW） |
| Efsubaglutide Alfa 40 mg QWEfsubaglutide Alfa 40 mg QW | Drug | Efsubaglutide 40 mg QW |
| Efsubaglutide Alfa 40 mg Q2WEfsubaglutide Alfa 40 mg Q2W | Drug | Efsubaglutide Alfa 40 mg Q2W |
| Efsubaglutide Alfa 80 mg QWEfsubaglutide Alfa 80 mg QW | Drug | Efsubaglutide Alfa 80 mg QW |
| Efsubaglutide Alfa 80 mg Q4WEfsubaglutide Alfa 80 mg Q4W | Drug | Efsubaglutide Alfa 80 mg Q4W |
| PlaceboPlacebo | Other | Efsubaglutide 20 mg Quaque Week (QW）, Efsubaglutide 40 mg QW, Efsubaglutide Alfa 40 mg Q2W, Efsubaglutide Alfa 80 mg Q4W, Efsubaglutide Alfa 80 mg QW |
Primary outcome
Percentage change (%) of body weight from baseline after subcutaneous administration of YN-011 for 22 weeks
Time frame: 22 weeks
24 secondary outcomes
Proportion of subjects with body weight loss ≥ 5%, ≥ 10%, and ≥ 15% from baseline after subcutaneous
Time frame: 22 weeks
Absolute change from baseline in body weight (Kg) after subcutaneous administration for 22 weeks
Time frame: 22 weeks
Changes from baseline in BMI after subcutaneous administration for 22 weeks
Time frame: 22 weeks
Changes from baseline in waist to hip circumference ratio after subcutaneous administration for 22 weeks
Time frame: 22 weeks
Changes from baseline in waist to height ratio after subcutaneous administration of YN-011 for 22 weeks
Time frame: 22 weeks
Changes from baseline in systolic and diastolic blood pressure after subcutaneous administration for 22 weeks
Time frame: 22 weeks
Changes from baseline in blood lipids (including TC, TG, LDL-C, and high-density lipoprotein cholesterol [HDL-C]) after subcutaneous administration for 22 weeks, percentage change from baseline, and ratio to baseline
Time frame: 22 weeks
Changes from baseline in glycated hemoglobin (HbA1c) after administration subcutaneous for 22 weeks
Time frame: 22 weeks
Changes from baseline in fasting plasma glucose(FPG) after subcutaneous administration of YN-011 for 22 weeks;
Time frame: 22 weeks
Changes from baseline in fasting insulin after subcutaneous administration of YN-011 for 22 weeks;
Time frame: 22 weeks
Changes from baseline in blood uric acid after subcutaneous administration for 22 weeks, percentage change from baseline, and ratio to baseline
Time frame: 22 weeks
Safety assessment will be conducted throught the study by Incidence of adverse events (AEs) and serious adverse events (SAEs);
Time frame: 22 weeks
Safety assessment will be conducted throught the study by Mental health status via Patient Health Questionnaire-9 (PHQ-9)
Time frame: 26 weeks
Safety assessment will be conducted throught the study by Mental health status via Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 26 weeks
Maximum plasma concentration (Cmax) of YN-011 via subcutaneous administration through the study
Time frame: 22 weeks
Timepoint of maximum plasma concentration (Tmax) of YN-011 via subcutaneous administration
Time frame: 22 weeks
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t) of YN-011 via subcutaneous administration
Time frame: 22 weeks
Elimination half-life (t1/2) of YN-011 via subcutaneous administration
Time frame: 22 weeks
Apparent clearance (CL/F) of YN-011 via subcutaneous administration
Time frame: 22 weeks
Apparent volume of distribution (Vz/F) of YN-011 via subcutaneous administration
Time frame: 22 weeks
Trough concentration (Ctrough) of YN-011 via subcutaneous administration
Time frame: 22 weeks
Incidence of anti-drug antibody (ADA) against YN-011 in serum before and after subcutaneous administration
Time frame: 22 weeks
Incidence of neutralizing antibody (NAb) against YN-011 in serum before and after subcutaneous administration
Time frame: 22 weeks
Changes from baseline in Dual Energy X-ray Absorptiometry [DEXA] data report (DEXA data inculding total fat mass, muscle mass, regional visceral fat mass and total lean body mass) after subcutaneous administration of YN-011
Time frame: 22 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Karen Kaluhin principal investigator
Canopy Clinical Sutherland Shire
5 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 20 mg QW, Efsubaglutide Alfa 40 mg QW and Efsubaglutide Alfa 40 mg Q2W in people with Obesity and Overweight, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 5 sites in Australia.
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 5 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QINGHUA WANG (862168788225, dr.qwang@innogenpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change (%) of body weight from baseline after subcutaneous administration of YN-011 for 22 weeks (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.