Nctid:
NCT06226090
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009765", "term"=>"Obesity"}, {"id"=>"D000050177", "term"=>"Overweight"}], "ancestors"=>[{"id"=>"D000044343", "term"=>"Overnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}, {"id"=>"D000001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M26186", "name"=>"Overweight", "asFound"=>"Overweight", "relevance"=>"HIGH"}, {"id"=>"M12701", "name"=>"Obesity", "asFound"=>"Obesity", "relevance"=>"HIGH"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>300}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-21", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2025-03-20", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-15", "studyFirstSubmitDate"=>"2024-01-11", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-16", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Number of TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events)", "timeFrame"=>"From baseline to week 27"}, {"measure"=>"Change from baseline to week 24 in serum calcitonin", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Change from baseline to week 24 in serum alanine transaminase", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Change from baseline to week 24 in serum creatinine", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Change from baseline to week 24 in serum HCG (Human Chorionic Gonadotophin)", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Plasma concentration of TG103", "timeFrame"=>"From baseline to week 27"}, {"measure"=>"Number of patients with positive TG103 antibody", "timeFrame"=>"From baseline to week 27"}], "primaryOutcomes"=>[{"measure"=>"Percentage relative change from baseline in body weight at week 24", "timeFrame"=>"From baseline to week 24"}], "secondaryOutcomes"=>[{"measure"=>"Proportion of participants with weight loss of ≥ 5% at week 24", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Proportion of participants with weight loss of ≥ 10% at week 24", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Change from baseline to week 24 in waist circumference", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Relative change from baseline in body weight at week 24", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Change from baseline to week 24 in systolic blood pressure", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Change from baseline to week 24 in diastolic blood pressure", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Title: Change from baseline to week 24 in serum total cholesterol", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Title: Change from baseline to week 24 in serum triglyceride", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol", "timeFrame"=>"From baseline to week 24"}, {"measure"=>"Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol", "timeFrame"=>"From baseline to week 24"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Obesity", "Overweight"]}, "descriptionModule"=>{"briefSummary"=>"This study is a randomized, double-blind, placebo-controlled, parallel phase 2 study to evaluate efficacy, safety, pharmacokinetic characteristics and immunogenicity of TG103 injection for weight management in non-diabetic patients with overweight in the presence of comorbidities or obesity, in addition to lifestyle intervention."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Male or female, 18 years ≤ age ≤ 75 years.\n* Body Mass Index (BMI) ≥ 28 kg/m\\^2, or 24 kg/m\\^2 \\< BMI ≤ 28 kg/m\\^2 with at least one of obesity-related complications.\n* Regular diet and exercise and stable body weight (i.e., self-reported body weight change \\< 5%) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.\n* Weight loss less than 5% or no weight loss after diet and exercise intervention for at least 12 weeks.\n\nExclusion Criteria:\n\n* History of type 2 diabetes, type 1 diabetes or hypoglycemia.\n* Overweight or obesity due to disease or drug; or weight increase due to non-fat mass increase; or monogenic obesity.\n* Medications or products which are judged by investigators to cause change in weight and influence trial evaluations have been used within 12 weeks before screening or will be used during study.\n* Weight loss less than 5% by monotherapy or combination with GLP-1 receptor agonists for at least 12 weeks before screening.\n* Bariatric surgery within 12 months before screening; or no full recovery from any surgery or injury at screening; or gastrointestinal motility dysfunction due to gastrointestinal surgery.\n* Participation in any clinical trial to receive treatment within 12 weeks before screening, or participation in clinical trial to receive TG103 before screening.\n* History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or suspected allergy to TG103 judged by investigator due to other severe allergy history.\n* Personal history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).\n* History or screening ultrasound reports of chronic pancreatitis, acute pancreatitis, etc.\n* History of severe gastrointestinal disease; or gastrointestinal symptom at screening; or discontinuation of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG receptor agonist or metformin due to gastrointestinal adverse reaction.\n* Severe infection at screening.\n* Skin disorder that influences safety evaluation at screening.\n* History of severe disease or malignant tumor.\n* Systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg, NYHA Grade Ⅲ-Ⅳ, QTc interval prolongation or severe arrhythmia at screening.\n* History of abnormal thyroid function with requirement of medication treatment at screening, or screening TSH beyond the normal reference range.\n* One of the followings at screening: 1) HbA1c ≥ 6.5%, or FPG ≥ 7.0mmol/L or\\<2.8mmol/L; 2) calcitonin ≥ 50 ng/L; 3) ALT or AST\\>3 × UNL (upper normal limit), or total bilirubin\\>1.5 × UNL; 4) blood amylase or lipase\\>1.5 × UNL, 5) TG\\>5.6mmol/L, 6) eGFR\\<60ml/min/1.73m\\^2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody, 8) WBC\\< 3×10\\^9/L, or Hb \\<100g/L, 9) INR\\>1.2.\n* History of drug abuse, drug dependence or alcoholism.\n* History of moderate to severe depression, or screening Patient Health Questionaire-9 (PHQ-9) score ≥ 15.\n* The fertile female who is pregnant, breast-feeding or with blood HCG positive at screening; or the fertile participants and their partner cannot use an effective contraceptive method during the trial and within 3 months after the end of treatment.\n* Other situations unsuitable for this study in the investigator\\'s opinion."}, "identificationModule"=>{"nctId"=>"NCT06226090", "briefTitle"=>"A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"CSPC Baike (Shandong) Biopharmaceutical Co., Ltd."}, "officialTitle"=>"A Randomized, Double-blind, Placebo-controlled Phase 2 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity", "orgStudyIdInfo"=>{"id"=>"SYSA1803-017"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"TG103 7.5 mg", "interventionNames"=>["Drug: TG103 7.5 mg"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo 7.5 mg", "interventionNames"=>["Drug: Placebo 7.5 mg"]}, {"type"=>"EXPERIMENTAL", "label"=>"TG103 15 mg", "interventionNames"=>["Drug: TG103 15 mg"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo 15 mg", "interventionNames"=>["Drug: Placebo 15 mg"]}, {"type"=>"EXPERIMENTAL", "label"=>"TG103 22.5 mg", "interventionNames"=>["Drug: TG103 22.5 mg"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo 22.5 mg", "interventionNames"=>["Drug: Placebo 22.5 mg"]}], "interventions"=>[{"name"=>"TG103 7.5 mg", "type"=>"DRUG", "description"=>"Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.", "armGroupLabels"=>["TG103 7.5 mg"]}, {"name"=>"Placebo 7.5 mg", "type"=>"DRUG", "description"=>"Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.", "armGroupLabels"=>["Placebo 7.5 mg"]}, {"name"=>"TG103 15 mg", "type"=>"DRUG", "description"=>"Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.", "armGroupLabels"=>["TG103 15 mg"]}, {"name"=>"Placebo 15 mg", "type"=>"DRUG", "description"=>"Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.", "armGroupLabels"=>["Placebo 15 mg"]}, {"name"=>"TG103 22.5 mg", "type"=>"DRUG", "description"=>"Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.", "armGroupLabels"=>["TG103 22.5 mg"]}, {"name"=>"Placebo 22.5 mg", "type"=>"DRUG", "description"=>"Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.", "armGroupLabels"=>["Placebo 22.5 mg"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"050011", "city"=>"Shijiazhuang", "state"=>"Hebei", "country"=>"China", "facility"=>"Clinical Trials Information Group", "geoPoint"=>{"lat"=>38.04139, "lon"=>114.47861}}], "overallOfficials"=>[{"name"=>"Li Yan Study Principal Investigator", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Sun Yat-sen Memorial Hospital,Sun Yat-sen University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
