Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-04 @ 1:21 AM
Study NCT ID:
NCT06732960
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of Efsubaglutide Alfa in Overweight or Obesity Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Relative Change in Body Weight (%), Proportion of subjects with a weight loss of ≥5% from baseline'}, {'measure': 'Adverse Event', 'timeFrame': 'Adverse events occurring within 4 weeks of the last dose from baseline', 'description': 'Numbers of Adverse Event'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Proportion of subjects with a weight loss of ≥10% or ≥15% from baseline, Change from baseline in weight'}, {'measure': 'BMI', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in BMI'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Waist circumference'}, {'measure': 'Hip circumference', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Hip circumference'}, {'measure': 'Waist Hip Rate (WHR)', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Waist Hip Rate (WHR)'}, {'measure': 'Diastolic pressure', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Diastolic pressure'}, {'measure': 'Systolic pressure', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Systolic pressure'}, {'measure': 'Triglyceride', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Triglyceride'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Total Cholesterol'}, {'measure': 'High Density Lipoprotein Cholesterol （HDL-C）', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in High Density Lipoprotein Cholesterol （HDL-C）'}, {'measure': 'Low-Density Lipoprotein Cholesterol （LDL-C）', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Low-Density Lipoprotein Cholesterol （LDL-C）'}, {'measure': 'HbA1c', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in HbA1c'}, {'measure': 'Fasting Blood Insulin', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in Fasting Blood Insulin'}, {'measure': 'HOMA-IR', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change from baseline in HOMA-IR'}, {'measure': 'Body Fat', 'timeFrame': 'Baseline, 4 weeks after the target dose', 'description': 'Change in body fat from baseline measured with a body fat scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obesity']}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa at difference dose range once-weekly in patients with Overweight or Obesity.', 'detailedDescription': "This study will look at the adverse events and the change in participants' body weight from the start of the study to the end. Weight loss in participants taking Efsubaglutide Alfa will be compared to weight loss in participants taking placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Fully understood the study, signed the informed consent.\n* Male or female patients aged from 18 to 75 years at the time of signing informed consent.\n* Body mass index (BMI) greater than or equal to 28 kg/sqm or greater than or equal to 24 kg/sqm with the presence of at least one of the following weight-related comorbidities: prediabetic state, hypertension, dyslipidemia, non-alcoholic steatohepatitis (NASH), obstructive sleep apnea or cardiovascular disease.\n* A self-reported change in body weight less than 5% within 90 days before screening irrespective.\n\nExclusion Criteria:\n\n* Glycated hemoglobin (HbA1c) greater than or equal to 6.5%, or previously diagnosed with type 1 diabetes or type 2 diabetes.\n* Have history of clinically significant abnormal gastric emptying, severe chronic gastrointestinal diseases, long-term use of medications that directly affect gastrointestinal peristalsis, or gastrointestinal surgery within 6 months prior to screening, and deemed unsuitable for participation by the investigator.\n* Have history of hyperthyroidism or hypothyroidism, or a thyroid-stimulating hormone (TSH) level below the lower limit or above 1.5 times the upper limit of the normal range.\n* Calcitonin greater than or equal to 50 ng/L, or have history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B syndrome, or a related family history.\n* Any other condition that, in the judgment of the researchers, may affect the patient's ability to provide informed consent or comply with the trial protocol."}, 'identificationModule': {'nctId': 'NCT06732960', 'acronym': 'LIGHT', 'briefTitle': 'A Study of the Efficacy and Safety of Efsubaglutide Alfa in Overweight or Obesity Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-controlled Study of Efsubaglutide Alfa on Weight Management in Subjects With Overweight or Obesity to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy.', 'orgStudyIdInfo': {'id': 'YN011-W201'}, 'secondaryIdInfos': [{'id': 'YN011-W201', 'type': 'OTHER', 'domain': 'Guangzhou Innogen Pharmaceutical Group Co., Ltd.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efsubaglutide Alfa 5mg', 'description': '10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.', 'interventionNames': ['Biological: Efsubaglutide Alfa', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Efsubaglutide Alfa 7.5mg', 'description': '10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 7.5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.', 'interventionNames': ['Biological: Efsubaglutide Alfa', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Efsubaglutide Alfa 10mg', 'description': '10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 6 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.', 'interventionNames': ['Biological: Efsubaglutide Alfa', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Efsubaglutide Alfa 15mg', 'description': '10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 8 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.', 'interventionNames': ['Biological: Efsubaglutide Alfa', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Efsubaglutide Alfa 20mg', 'description': '10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa orPlacebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 12 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.', 'interventionNames': ['Biological: Efsubaglutide Alfa', 'Other: Placebo']}], 'interventions': [{'name': 'Efsubaglutide Alfa', 'type': 'BIOLOGICAL', 'otherNames': ['Supaglutide'], 'description': 'Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.', 'armGroupLabels': ['Efsubaglutide Alfa 10mg', 'Efsubaglutide Alfa 15mg', 'Efsubaglutide Alfa 20mg', 'Efsubaglutide Alfa 5mg', 'Efsubaglutide Alfa 7.5mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo subcutaneous injection weekly', 'armGroupLabels': ['Efsubaglutide Alfa 10mg', 'Efsubaglutide Alfa 15mg', 'Efsubaglutide Alfa 20mg', 'Efsubaglutide Alfa 5mg', 'Efsubaglutide Alfa 7.5mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'China', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Jinan', 'state': 'China', 'country': 'China', 'facility': 'Jinan Central Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'China', 'country': 'China', 'facility': "Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Weiping Jia, M.D,Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital", 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'Jinan Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}