The Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects (ENLIGHT)
NCT ID: NCT06921486
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
1003 participants
INTERVENTIONAL
2025-03-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Phase IIb：Efsubaglutide Alfa 5 mg QW
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, reaching the target dose of 5 mg at Week 3 (W3). From W3 to W18, the treatment is maintained at a 5 mg dose.
Phase IIb：Efsubaglutide Alfa 5 mg QW
IIb：Efsubaglutide Alfa 5 mg QW
Phase IIb：Efsubaglutide Alfa 10 mg QW
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, reaching the target dose of 10 mg at Week 5 (W5). From W5 to W18, the treatment is maintained at a 10 mg dose.
Phase IIb：Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa 10 mg QW
Phase IIb：Efsubaglutide Alfa 20 mg QW
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 at Week 7 (W7). From W7 to W18, the treatment is maintained at a 20 mg dose.
Phase IIb：Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa 20 mg QW
Phase IIb：Efsubaglutide Alfa 20 mg Q2W
From Week 1 (W1) to Week 6 (W6), 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 at Week 7 (W7). From W7 to W18, the drug is administered every two weeks and maintained at a 20 mg dose.
Phase IIb：Efsubaglutide Alfa 20 mg Q2W
Efsubaglutide Alfa 20 mg Q2W
Phase IIb：Placebo
Once weekly
Phase IIb：Placebo
Placebo
Phase III：Recommended Phase 3 Dose (RP3D) Low Dose QW
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, The dose escalation continues until reaching the RP3D Low Dose, and then the RP3D is maintained. The total cumulative duration of drug administration (from the first dose to the end of maintenance) is 48 weeks, with the once-weekly administration frequency retained throughout the entire period.
Phase III：Recommended Phase 3 Dose Low Dose
The Recommended Phase 3 Dose Low Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.
Phase III：Recommended Phase 3 Dose (RP3D) High Dose QW
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, The dose escalation continues until reaching the RP3D High Dose, and then the RP3D is maintained. The total cumulative duration of drug administration (from the first dose to the end of maintenance) is 48 weeks, with the once-weekly administration frequency retained throughout the entire period.
Phase III：Recommended Phase 3 Dose High Dose
The Recommended Phase 3 Dose High Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.
Phase III：Recommended Phase 3 Dose (RP3D) High Dose Q2W
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: 1 mg → 5 mg → 10 mg → 20 mg. Dose escalation continues until reaching the RP3D High Dose. Once the RP3D High Dose is achieved, the treatment regimen transitions to alternating weekly between RP3D High Dose and placebo for the remainder of the study. The total cumulative duration of drug administration (from the first dose to the end of the maintenance phase) remains 48 weeks, with the once-weekly administration frequency retained throughout. Blinding is maintained across all treatment groups to ensure unbiased evaluation of efficacy and safety.
Phase III：Recommended Phase 3 Dose High Dose
The Recommended Phase 3 Dose High Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.
Phase III：Placebo
Placebo
Phase III：Placebo
Once weekly
Phase III：Placebo
Placebo
Interventions
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Phase IIb：Efsubaglutide Alfa 5 mg QW
IIb：Efsubaglutide Alfa 5 mg QW
Phase IIb：Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa 10 mg QW
Phase IIb：Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa 20 mg QW
Phase IIb：Efsubaglutide Alfa 20 mg Q2W
Efsubaglutide Alfa 20 mg Q2W
Phase IIb：Placebo
Placebo
Phase III：Recommended Phase 3 Dose High Dose
The Recommended Phase 3 Dose High Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.
Phase III：Recommended Phase 3 Dose Low Dose
The Recommended Phase 3 Dose Low Dose confirmed by the IDMC (Independent Data Monitoring Committee) based on the safety and efficacy data results from the 18-week Phase IIb.
Phase III：Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years (including the cutoff value, based on the time of signing the ICF), regardless of gender.
3. History of poor weight control through diet and exercise \[defined as weight control failure if the subject has attempted at least 3 months of diet and exercise alone prior to screening without achieving a weight loss of ≥ 5.0% (based on subject self-report)\].
4. Willing to follow the recommendations of the investigator regarding medication, diet, and exercise.
5. Stable weight within 3 months prior to screening (defined as a weight change \< 5%, based on subject self-report).
6. Obesity: Body Mass Index (BMI) ≥ 28 kg/m² (including the cutoff value) with or without comorbidities; or overweight: BMI ≥ 24 and \< 28 kg/m² with at least one weight-related comorbidity, including but not limited to prediabetes (impaired fasting glucose \[FPG\] and/or abnormal glucose tolerance), hypertension, dyslipidemia, non-alcoholic fatty liver disease, or obstructive sleep apnea syndrome.
7. Women of childbearing potential must have a negative blood pregnancy test during the screening period. Women of childbearing potential or male subjects and their partners must agree not to plan for pregnancy from the time of signing the ICF until 3 months after the last dose of the investigational drug, and voluntarily agree to use effective contraception, with no plans for sperm or egg donation.
Exclusion Criteria
2. Previously treated with Efsubaglutide Alfa injection.
3. Received glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulin, metformin, insulin secretagogues, or thiazolidinediones (TZD) or any other weight-affecting anti-diabetic medication within the past 3 months before screening.
4. HbA1c ≥ 6.5% at screening, or previously diagnosed with Type 1 or Type 2 diabetes (based on the World Health Organization \[WHO\] 2020 diabetes diagnosis and classification standards).
5. History of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 times in the past 6 months).
6. Known single-gene mutations, other diseases, or drug-induced obesity, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, growth hormone deficiency, acromegaly, pseudohypoparathyroidism, gonadal dysfunction, etc.
7. Clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., active ulcers in the past 6 months), long-term use of drugs directly affecting gastrointestinal motility (including but not limited to mosapride, cisapride, etc.), or having undergone gastrointestinal surgery within the past 6 months and deemed unsuitable for participation by the investigator.
8. Use of weight-affecting medications within 3 months prior to screening, including tricyclic antidepressants, psychiatric medications, or sedative drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, sulpiride, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts, etc.). Note: Excluded if cumulative or continuous systemic steroid use is less than 14 days.
9. Use of non-prescription weight loss medications or appetite suppressants (including traditional Chinese medicine weight loss drugs) within 1 month prior to screening, or use of prescription weight loss medications (e.g., phentermine, sibutramine, orlistat) or lipid-dissolving injectables (e.g., lipolytic injections) within 3 months prior to screening.
10. Previously underwent weight-loss surgery (excluding acupuncture, liposuction, and abdominal fat removal within 1 year before screening), or plans to undergo surgery for obesity during the study period, such as gastric bypass surgery or gastric band surgery.
11. Currently on a weight loss plan and not in the maintenance phase.
12. History of hyperthyroidism or hypothyroidism, or thyroid-stimulating hormone (TSH) \< 1×LLN (lower limit of normal) or TSH \> 1.5×ULN (upper limit of normal).
13. Screening serum calcitonin ≥ 50 ng/L (or ≥ 50 pg/mL), or history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) syndrome type 2A or 2B, or related family history (family history defined as a first-degree relative with the disease).
14. History of acute or chronic pancreatitis, cholecystectomy, or symptomatic gallbladder disease (patients with post-surgery resolved gallstones or cholecystectomy without sequelae can be enrolled), or known history of pancreatic injury or high-risk factors for pancreatitis, or screening with serum amylase or lipase \> 2×ULN.
15. Any disease that could affect HbA1c measurement, such as hemolytic anemia, sickle cell disease, etc.
16. Currently receiving or have received chronic (\> 14 days) systemic corticosteroid treatment in the past 3 months (excluding local, intraocular, intranasal, intra-articular, or inhaled formulations), or have evidence of severe, active autoimmune disorders (e.g., lupus or rheumatoid arthritis), and, in the opinion of the investigator, require or may require systemic corticosteroid treatment within the next 12 months.
17. History of malignancy within 5 years prior to screening, excluding clinically cured cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma within the past 5 years.
18. History of major surgery (e.g., thoracic, intracranial, or abdominal surgery) within 6 months prior to screening, or plans to undergo surgery that may affect study completion or adherence.
19. Meets any of the following cardiac function criteria: clinically significant arrhythmias or conduction abnormalities requiring clinical intervention; hereditary long QT syndrome or QTcF \> 450 msec or currently taking medications that may prolong the QT interval or cause torsades de pointes; clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina, coronary artery bypass graft surgery, New York Heart Association (NYHA) class III or higher congestive heart failure, left ventricular ejection fraction (LVEF) \< 50%, or uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg); other clinically significant cardiac abnormalities judged by the investigator.
20. History of hemorrhagic or ischemic stroke or transient ischemic attack within 6 months prior to screening.
21. Known infectious diseases: hepatitis B surface antigen (HBsAg) positive; hepatitis C virus (HCV) antibody positive and HCV RNA above the detection limit; human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.
22. Laboratory findings meeting any of the following: alanine aminotransferase (ALT) ≥ 3.0×ULN (subjects diagnosed with non-alcoholic fatty liver disease during screening and within the past 6 months with ALT ≤ 5.0×ULN may be enrolled); aspartate aminotransferase (AST) ≥ 3.0×ULN; total bilirubin (TBIL) ≥ 2.0×ULN; estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m² (CKD-EPI formula); fasting triglycerides (TG) \> 5.65 mmol/L.
23. Known or suspected alcohol abuse within 1 year prior to screening (defined as male subjects consuming \> 24 g alcohol per day, female subjects consuming \> 12 g alcohol per day; 12 g alcohol is approximately equivalent to 300 mL beer, 100 mL wine, or 25 mL spirits).
24. Known or suspected drug abuse at screening.
25. Pregnant or breastfeeding women.
26. History of moderate to severe depression, anxiety, or serious mental disorders, such as schizophrenia, bipolar disorder, etc., or screening PHQ-9 score ≥ 15.
27. History of suicidal tendencies or suicide attempts.
28. Participation in a clinical trial involving vaccines, medical devices, or other drugs within 3 months prior to screening (except for observational studies).
29. The investigator or treating physician considers that the subject has any factors that may affect the evaluation of the efficacy or safety of the study, and is deemed unsuitable for participation in the study.
18 Years
ALL
No
Sponsors
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Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Weiping Jia, M.D,Ph. D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Beijing Tsinghua Changgung Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Changzhou First People's Hospital
Changzhou, , China
Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
Chengdu, , China
Nanfang Hospital Southern Medical University
Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
The First Affiliateo Hospital of Jinan University
Guangzhou, , China
Zhujiang Hospital of Southern Medical University
Guangzhusi, , China
The First People'S Hospital of Zunyi
Guizhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, , China
Anhui Provincial Hospital
Hefei, , China
The First Affiliated Hospital of Henan University of Science and Technology
Henan, , China
The First Affiliated Hospital of Nanyang Medical College
Henan, , China
Pingxiang People's Hospital
Jiangxi, , China
Jincheng General Hospital
Jincheng, , China
The Third Affiliated Hospital
Jinzhou, , China
The First People's Hospital of Yunnan Province
Kunming, , China
Luan City People's Hospital
Lu'an, , China
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, , China
Nan Jing First Hospital
Nanjing, , China
The Second Hospital of Nanjing Medical University
Nanjing, , China
The Affiliated Qingyuan Hospital ,Guangzhou Medical University（Qingyuan People's Hospital）
Qingyuan, , China
The First Hospital of Qinhuangdao
Qinhuangdao, , China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Shandong, , China
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
The First Hospital Of China Medical University
Shenyang, , China
Shenzhen Second People's Hospital
Shenzhen, , China
The First Hospital of Hebei Medical University
Shijiazhuang, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
Suzhou Municipal Hospital
Suzhou, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
General Hospital of Tianjin Medical University
Tianjin, , China
Tianjin Medical University Chu Hsien-I Memorial Hospital
Tianjin, , China
Tenth People's Hospital Of Tongji University
Wuhan, , China
Wuhan Third Hospital Tongren Hospital of Wuhan University
Wuhan, , China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xianian, , China
Yueyang Central Hospital
Yueyang, , China
Countries
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Other Identifiers
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YN011-W202
Identifier Type: OTHER
Identifier Source: secondary_id
YN011-W303
Identifier Type: OTHER
Identifier Source: secondary_id
YN011-W303
Identifier Type: -
Identifier Source: org_study_id
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