Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-02-20 @ 12:37 PM
Study NCT ID:
NCT06254261
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2024-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RAY1225 in Participants With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2024-02-03', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline,Week26', 'description': 'Percent Change from Baseline in Body Weight'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve ≥10% Body Weight Reduction', 'timeFrame': 'Baseline,Week26'}, {'measure': 'Percentage of Participants Who Achieve ≥15% Body Weight Reduction', 'timeFrame': 'Baseline,Week26'}, {'measure': 'Percentage of Participants Who Achieve ≥5% Body Weight Reduction', 'timeFrame': 'Baseline,Week26'}, {'measure': 'Change from Baseline in Waist Circumference in Centimeter', 'timeFrame': 'Baseline,Week26'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with Obesity. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have a body mass index (BMI) of ≥28 kilogram per square meter (kg/m²) or ≥24 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or HbA1c ≥5.7% and \\< 6.5%;\n2. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.\n\nExclusion Criteria:\n\n1. Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity\n2. with a history of diabetes or hypoglycemia;\n3. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.\n4. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \\>1 year prior to screening)\n5. allergic constitution;\n6. not suitable for subcutaneous injection.'}, 'identificationModule': {'nctId': 'NCT06254261', 'briefTitle': 'A Study of RAY1225 in Participants With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Raynovent Biotech Co., Ltd'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Obesity', 'orgStudyIdInfo': {'id': 'RAY1225-23-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RAY1225 (cohort 1)', 'description': 'Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.', 'interventionNames': ['Drug: RAY1225']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (cohort 1)', 'description': 'Participants received Placebo administered SC once two weeks for 24 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'RAY1225 (cohort 2)', 'description': 'Escalating doses of RAY1225 administered subcutaneously (SC) once two week', 'interventionNames': ['Drug: RAY1225']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (cohort 2)', 'description': 'Participants received Placebo administered SC once two week', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RAY1225', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['RAY1225 (cohort 1)', 'RAY1225 (cohort 2)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo (cohort 1)', 'Placebo (cohort 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijingcun', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'JI, professor', 'role': 'CONTACT', 'email': 'iao@pkuph.edu.cn', 'phone': '88326666'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 41.26103, 'lon': 119.10946}}], 'centralContacts': [{'name': 'JI, professor', 'role': 'CONTACT', 'email': 'iao@pkuph.edu.cn', 'phone': '88326666'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Raynovent Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}