Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT07205432
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)', 'timeFrame': 'SAD: up to Day 8 MAD: up to Day 57'}], 'secondaryOutcomes': [{'measure': 'The maximum plasma concentration (Cmax) of XTL6001', 'timeFrame': 'Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.', 'description': 'Cmax - Maximum plasma concentration'}, {'measure': 'Tmax of XTL6001', 'timeFrame': 'Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.', 'description': 'The time to maximum concentration (Tmax) of XTL6001'}, {'measure': 'Elimination half-life (T1/2) of XTL6001', 'timeFrame': 'Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.', 'description': 't1/2 - Elimination half-life'}, {'measure': 'Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001', 'timeFrame': 'Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.', 'description': 'AUC0-tau - Area under the plasma concentration-time curve during one dosing interval'}, {'measure': 'AUC0-t of XTL6001', 'timeFrame': 'Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.', 'description': 'AUC0-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration'}, {'measure': 'Body weight', 'timeFrame': 'MAD: up to Day57', 'description': 'Body weight'}, {'measure': 'Body mass index （BMI）', 'timeFrame': 'MAD: up to Day57', 'description': 'Body mass index'}, {'measure': 'Waist circumference', 'timeFrame': 'MAD: up to Day57', 'description': 'waist circumference'}, {'measure': 'Waist-to-hip ratio', 'timeFrame': 'MAD: up to Day57', 'description': 'waist-to-hip ratio'}, {'measure': 'Blood lipids', 'timeFrame': 'MAD: up to Day57', 'description': 'Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B'}, {'measure': 'Blood glucose', 'timeFrame': 'MAD: up to Day57', 'description': 'Blood glucose'}, {'measure': 'Insulin', 'timeFrame': 'MAD: up to Day57', 'description': 'Insulin'}, {'measure': 'Uric acid', 'timeFrame': 'MAD: up to Day57', 'description': 'Uric acid'}, {'measure': 'Anti-drug antibodies (ADA)', 'timeFrame': 'MAD: up to Day57', 'description': 'Incidence of anti-drug antibodies (ADA)'}, {'measure': 'ADA', 'timeFrame': 'MAD: up to D57', 'description': 'Time to ADA positivity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Management in Adult Patients With Obesity or Overweight']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects.\n\nSAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion Criteria for Subjects in SAD part:\n\n1. Age ≥ 18 and \\< 65 years at screening.\n2. Body mass index (BMI) ≥ 18.5 kg/m² and \\< 28.0 kg/m² at screening.\n3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.\n4. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.\n\nInclusion Criteria for Subjects in MAD part:\n\n1. Age ≥ 18 and \\< 65 years at screening.\n2. BMI ≥ 18.5 kg/m2且 \\< 40.0kg/m².\n3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.\n4. Stable body weight (fluctuation \\< 5%) for at least 3 months prior to screening.\n5. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.\n\nExclusion Criteria:\n\nExclusion Criteria for Subjects in SAD part:\n\n1. History of type 1 or type 2 diabetes mellitus, or HbA1c \\> 6.5% or fasting plasma glucose \\> 7.0 mmol/L at screening.\n2. Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.\n3. History of acute or chronic pancreatitis.\n4. Symptomatic gallbladder disease.\n5. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).\n6. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).\n7. Female subjects with positive pregnancy test or lactation.\n\nExclusion Criteria for Subjects in MAD part:\n\n1. History of type 1 or type 2 diabetes mellitus, or HbA1c \\> 6.5% or fasting plasma glucose \\> 7.0 mmol/L at screening.\n2. UnderlyingCushing's syndrome, hypothyroidism, PCOS,.\n3. Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or gastrointestinal surgeries that may compromise safety or data interpretation.\n4. History of acute or chronic pancreatitis.\n5. Symptomatic gallbladder disease.\n6. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).\n7. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).\n8. Female subjects with positive pregnancy test or lactation."}, 'identificationModule': {'nctId': 'NCT07205432', 'briefTitle': 'Phase I Study of XTL6001 Injection in Healthy and Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Xitaili Biomedicine Technology co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Administration of XTL6001 Injection in Healthy and Obese Subjects', 'orgStudyIdInfo': {'id': 'XTL6001-I-C01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XTL6001', 'description': 'Interventional: The SAD study involves single administration of XLT6001, while the MAD study involves administration of XLT6001 for no more than 4 weeks.', 'interventionNames': ['Drug: XTL6001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: The SAD study involves single administration of Placebo, while the MAD study involves administration of Placebo for no more than 4 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'XTL6001', 'type': 'DRUG', 'description': 'XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases', 'armGroupLabels': ['XTL6001']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'This intervention contains no active ingredients', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Hua Hao, Ph.D. in Medicine', 'role': 'CONTACT', 'email': 'xiaohualuck@sina.com', 'phone': '010-63926883'}], 'facility': 'Beijing Shijitan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiao Hua Hao, Ph.D. in Medicine', 'role': 'CONTACT', 'email': 'xiaohualuck@sina.com', 'phone': '010-63926883'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Xitaili Biomedicine Technology co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}