Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT06184568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2023-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719829', 'term': 'mazdutide'}, {'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 349}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss', 'timeFrame': 'Week 32'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss', 'timeFrame': 'Week 32'}, {'measure': 'Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss', 'timeFrame': 'Week 32'}, {'measure': 'Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss', 'timeFrame': 'Week 32'}, {'measure': 'Change from Baseline in HbA1c', 'timeFrame': 'Week 32'}, {'measure': 'Change from Baseline in Fasting Plasma Glucose', 'timeFrame': 'Week 32'}, {'measure': 'Proportion of subjects who achieve composite endpoint of HbA1c <7.0%，≤6.5% or <5.7%', 'timeFrame': 'Week 32'}, {'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Week 32'}, {'measure': 'Change from Baseline in Waist Circumference', 'timeFrame': 'Week 32'}, {'measure': 'Proportion of subjects who achieve ≥5%, ≥10% or ≥15% weight loss', 'timeFrame': 'Week 32'}, {'measure': 'Change from Baseline in Blood Pressure(Systolic and Diastolic)', 'timeFrame': 'Week 32'}, {'measure': 'Percent Change from Baseline in Triglycerides, Total Cholesterol, LDL-c, HDL-c, non-HDL-c', 'timeFrame': 'Week 32'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, Open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 6 mg OW versus Semalgutide 1 mg OW in obese(BMI≥28kg/m2) early T2D subjects. Subjects will be randomly assigned to IBI362 6 mg and Semalgutide 1 mg groups for 32 weeks (active-controlled treatment period). In the extension period, participants originally on mazdutide were assigned to continue for an additional 24 weeks with mazdutide 9 mg or 6 mg based on whether they achieved the weight-loss target. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 32-week active-controlled treatment period, a 24 week extension period and a 4-week drug withdrawal safety follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18 years or older at the time of signing informed consent\n* T2D was diagnosed according to WHO standards in 1999(≤5 years)\n* The blood glucose was not well controlled after diet and exercise with/without sable metformin(≥1500mg/day，no more than 2550mg/day) within 3 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤9.5% during screening\n* Have a BMI ≥28 kg/m2\n\nExclusion Criteria:\n\n* Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs\n* A self-reported change in body weight above 5% within 3 months before screening\n* Oral hypoglycemic drugs other metformin have been used within 2 months before screening.\n* Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes)\n* There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)\n* Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study\n* Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period\n* The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study'}, 'identificationModule': {'nctId': 'NCT06184568', 'briefTitle': 'A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Open-label Phase 3 Study Comparing the Efficacy and Safety of IBI362 Versus Semaglutide in Chinese Participants With Early Type 2 Diabetes and Obesity (DREAMS-3)', 'orgStudyIdInfo': {'id': 'CIBI362A303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Semaglutide', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'IBI362', 'interventionNames': ['Drug: IBI362']}], 'interventions': [{'name': 'IBI362', 'type': 'DRUG', 'description': 'Once-weekly injections of gradually increased doses of IBI362, subcutaneously (SC)，starting dose is IBI362 2.0 mg, continuous After 4 weeks of administration, increase to IBI362 4.0 mg. After 4 weeks of continuous administration, continue to increase to IBI362.', 'armGroupLabels': ['IBI362']}, {'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Once-weekly injections of gradually increased doses of Semaglutide, subcutaneously (SC)，starting dose is semaglutide 0.25mg, after 4 weeks of continuous administration, increase to semaglutide 0.5mg, after 4 weeks of continuous administration, continue Upgrade to semaglutide 1.0 mg for 24 weeks.', 'armGroupLabels': ['Semaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}