[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654776":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":11,"studyPopulation":11,"armGroups":66,"interventions":108,"overallOfficials":11,"centralContacts":118,"locations":124,"responsibleParty":143,"collaborators":11,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":11,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":11,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":11,"overallStatus":164,"whyStopped":11,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"CSPC Ouyi Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment",null,"28 weeks",[14,17,20,22,24,26,28,30,32,34,36,38,40,42,44,46,49,51,53],{"measure":15,"description":11,"timeFrame":16},"Proportion of subjects with a weight loss of ≥5% , 10%, 15% from baseline at 28 weeks of treatment","Baseline through Week 28",{"measure":18,"description":11,"timeFrame":19},"Change from baseline in body Weight","Week 2, 4, 8, 12, 16, 20, 24 and 28",{"measure":21,"description":11,"timeFrame":16},"Changes from baseline in waist circumference",{"measure":23,"description":11,"timeFrame":16},"Changes from baseline in hip circumference",{"measure":25,"description":11,"timeFrame":16},"Changes from baseline in waist-to-hip ratio",{"measure":27,"description":11,"timeFrame":16},"Changes from baseline in Body Mass Index (BMI)",{"measure":29,"description":11,"timeFrame":16},"Changes from baseline in Hemoglobin A1c (HbA1c)",{"measure":31,"description":11,"timeFrame":16},"Changes from baseline in fasting plasma glucose (FPG)",{"measure":33,"description":11,"timeFrame":16},"Changes from baseline in fasting C-peptide",{"measure":35,"description":11,"timeFrame":16},"Changes from baseline in Homeostatic Model Assessment of Insulin Resistance(HOMA-IRs)",{"measure":37,"description":11,"timeFrame":16},"Changes from baseline in systolic blood pressure",{"measure":39,"description":11,"timeFrame":16},"Changes from baseline in diastolic blood pressure",{"measure":41,"description":11,"timeFrame":16},"Changes from baseline in lipid parameters (TC, LDL-C, HDL-C, non-HDL-C, TG, ApoB)",{"measure":43,"description":11,"timeFrame":16},"Changes from baseline in high sensitivity C reactive protein (hs-CRP)",{"measure":45,"description":11,"timeFrame":16},"Changes from baseline in urinary albumin-to-creatinine ratio (UACR)",{"measure":47,"description":11,"timeFrame":48},"The incidence rate of adverse events (AEs)","Baseline through Week 31",{"measure":50,"description":11,"timeFrame":48},"Plasma concentrations & PK parameters: Peak Time (Tmax)",{"measure":52,"description":11,"timeFrame":48},"Plasma concentrations & PK parameters: Peak Plasma Concentration (Cmax)",{"measure":54,"description":11,"timeFrame":48},"Plasma concentrations & PK parameters: Area under the plasma concentration versus time curve(AUC) : AUClast, AUC0-168h, AUC0-336h",{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":11,"timePerspective":11,"maskingInfo":60},"RANDOMIZED","PARALLEL","A multicenter, randomized, double-blind, placebo parallel-controlled Phase II clinical study","TREATMENT",{"masking":61,"maskingDescription":11,"whoMasked":62},"TRIPLE",[63,64,65],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[67,73,78,82,86,90,94,98,102],{"label":68,"type":69,"description":70,"interventionNames":71},"Treatment group A","ACTIVE_COMPARATOR","SYH2069 dose 1 :\n\nSYH2069 Injection: dose level 1 for 28 weeks",[72],"Drug: SYH2069 Injection",{"label":74,"type":75,"description":76,"interventionNames":77},"Treatment group B","EXPERIMENTAL","SYH2069 dose 2:\n\nSYH2069 Injection: dose level 2 for 28 weeks",[72],{"label":79,"type":75,"description":80,"interventionNames":81},"Treatment group C","SYH2069 dose 3:\n\nSYH2069 Injection: dose level 3 for 28 weeks",[72],{"label":83,"type":75,"description":84,"interventionNames":85},"Treatment group D","SYH2069 dose 4:\n\nSYH2069 Injection: dose level 4 for 28 weeks",[72],{"label":87,"type":75,"description":88,"interventionNames":89},"Treatment group E","SYH2069 dose 5:\n\nSYH2069 Injection: dose level 5 for 28 weeks",[72],{"label":91,"type":75,"description":92,"interventionNames":93},"Treatment group F","SYH2069 dose 6:\n\nSYH2069 Injection: dose level 6 for 28 weeks",[72],{"label":95,"type":75,"description":96,"interventionNames":97},"Treatment group G","SYH2069 dose 7:\n\nSYH2069 Injection: dose level 7 for 28 weeks",[72],{"label":99,"type":75,"description":100,"interventionNames":101},"Treatment group H","SYH2069 dose 8:\n\nSYH2069 Injection: dose level 8 for 28 weeks",[72],{"label":103,"type":104,"description":105,"interventionNames":106},"Treatment group I","PLACEBO_COMPARATOR","SYH2069 Injection Placebo:\n\nPlacebo arm matching active arm SYH2069 Injection dose level for 28 weeks",[107],"Drug: SYH2069 Injection Placebo",[109,114],{"type":110,"name":111,"description":112,"armGroupLabels":113,"otherNames":11},"DRUG","SYH2069 Injection","0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol",[68,74,79,83,87,91,95,99],{"type":110,"name":115,"description":116,"armGroupLabels":117,"otherNames":11},"SYH2069 Injection Placebo","0.6ml , 1.2ml , SC，Administer the drug according to the clinical trial protocol",[103],[119],{"name":120,"role":121,"phone":122,"phoneExt":11,"email":123},"Clinical Trials Information Group Officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",[125],{"facility":126,"status":11,"city":127,"state":128,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School","Nanjing","Jiangsu","210000","China","CN",{"type":133,"coordinates":134},"Point",[135,136],118.77778,32.06167,{"lat":136,"lon":135},[139],{"name":140,"role":121,"phone":141,"phoneExt":11,"email":142},"Yan Bi","86-25-83106666","biyan@nju.edu.cn",{"type":144,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100654776","phase-2-efficacy-and-safety-of-syh2069-injection-in-obese-participants-without-diabetes-100654776",false,"NCT07803991","Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes.","A Multicenter, Randomized, Double-blind, Placebo Parallel-Controlled, Phase II Study to Evaluate the Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes","Inclusion Criteria:\n\n* 1.Male or female participants, 18-65 years of age at the time of signing informed consent;\n* 2.At screening visit, 28.0 kg\u002Fm\\^2≤BMI≤ 40.0 kg\u002Fm\\^2;\n* 3.Maintained consistent diet and exercise habits with stable body weight within the 12 weeks prior to screening (self-reported weight variation \\\u003C5%).;\n* 4.Able to understand and comply with trial procedures, voluntarily participate in the trial, and provide written informed consent (ICF).\n\nExclusion Criteria:\n\n* 1\\. Participants with a history of diabetes mellitus or hypoglycemic episodes;\n* 2\\. Participants with obesity caused by known single-gene mutations, other medical conditions, or medications, or weight gain not resulting from increased adipose tissue mass;\n* 3\\. Use of any medications or products that alter body weight and interfere with weight assessment within 3 months prior to screening;\n* 4\\. Prior bariatric surgery or weight-loss interventions, or plan to receive any bariatric surgery or weight-loss intervention during the trial.\n* 5\\. History of or known hypersensitivity to any active ingredient or excipient of the investigational product; known allergic diathesis; or severe allergic diseases present at screening.\n* 6\\. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).\n* 7\\. Prior history of acute or chronic pancreatitis or pancreatic injury; history of acute gallbladder disease within 1 year prior to screening; .\n* 8\\. History of severe cardiovascular or cerebrovascular events within 6 months prior to screening.\n* 9\\. Prior severe respiratory, central nervous system or psychiatric disorders; any suicide attempts within the past 2 years, or suicidal ideation within 3 months prior to screening or during screening;\n* 10\\. Any treated or untreated malignancy diagnosed from 5 years before screening through randomization (clinically cured basal cell carcinoma or carcinoma in situ are exempted).\n* 11\\. Clinically significant hematological diseases, hemolytic or red blood cell disorders, or baseline conditions that interfere with HbA1c measurement at screening or randomization.\n* 12\\. Participants with inadequately controlled blood pressure\n* 13\\. History of alcohol abuse, substance misuse or illicit drug use prior to screening\n* 14\\. Severe trauma, severe or acute infection occurring within 3 months prior to screening or between screening and randomization\n* 15\\. Prior clinical trial exposure to study drug within 90 days pre-screening or 5 drug half-lives, whichever is longer.\n* 16\\. Pregnancy or lactation; fertile male or female participants and their partners who fail to use effective contraception throughout the trial and for 3 months following the end of treatment.\n* 17\\. Any other conditions that, in the investigator's judgment, render the participant unsuitable for this study.","ALL","18 Years","65 Years",{"count":156,"type":157},360,"ESTIMATED","INTERVENTIONAL",[160],"PHASE2","To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.",[163],"Overweight or Obesity","NOT_YET_RECRUITING","2026-08-31",{"date":167,"type":168},"2026-09-04","ACTUAL",{"date":170,"type":157},"2026-09-01",{"date":172,"type":157},"2027-12-31",{"name":5,"class":6},1]