Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-02 @ 8:24 AM
Study NCT ID:
NCT06519656
Status:
RECRUITING
Last Update Posted:
2024-10-24
First Post:
2024-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Mazdutide for Treating PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719829', 'term': 'mazdutide'}, {'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}], 'ancestors': [{'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-07-14', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free Androgen Index (FAI)', 'timeFrame': '24 weeks', 'description': 'FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100'}], 'secondaryOutcomes': [{'measure': 'Times of regular menses', 'timeFrame': '24 weeks', 'description': 'Record of vaginal bleeding within 24 weeks after using Mazdutide'}, {'measure': 'Number of immature follicles', 'timeFrame': '24 weeks', 'description': 'Total number of follicles measuring 2-9 mm in diameter on ultrasound'}, {'measure': 'Bilateral ovary volume', 'timeFrame': '24 weeks', 'description': 'Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound'}, {'measure': 'Serum anti-Mullerian hormone (AMH)', 'timeFrame': '24 weeks', 'description': 'Measurement of serum AMH'}, {'measure': 'HOMA insulin resistance index (HOMA-IR)', 'timeFrame': '24 weeks', 'description': 'HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5'}, {'measure': 'HbA1c', 'timeFrame': '24 weeks', 'description': 'Measurement of HbA1c'}, {'measure': 'body mass index (BMI)', 'timeFrame': '24 weeks', 'description': 'BMI = weight / height² (weight in kilograms and height in meters)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI≥28kg/M2\n* No plan for pregnancy in the coming 8 months after enrollment\n* Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :\n\n 1. Irregular cycles and ovulatory dysfunction: \\< 21 or \\> 35 days or \\< 8 cycles per year; \\> 90 days for any one cycle\n 2. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\\<10mm), confirmed by ultrasound\n 3. Biochemical hyperandrogenism: total testosterone\\>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)\\>4\n\nExclusion Criteria:\n\n* Previous history of acute or chronic pancreatitis or pancreatic injury\n* Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b\n* Severe hypertriglyceridemia (TG\\>5mmol/L)\n* Type 1 or type 2 diabetes mellitus\n* Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc\n* Pregnancy or breast-feeding\n* Patients with other serious diseases affecting heart, liver, kidney, or other major organs\n* Patients with any type of cancer"}, 'identificationModule': {'nctId': 'NCT06519656', 'briefTitle': 'Efficacy of Mazdutide for Treating PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'B2024-190R2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mazdutide Treatment Arm', 'description': 'Subcutaneous injection of Mazdutide once weekly for 24 weeks.', 'interventionNames': ['Drug: Mazdutide']}], 'interventions': [{'name': 'Mazdutide', 'type': 'DRUG', 'otherNames': ['GLP-1R and GCGR dual agonist'], 'description': 'In the initial 4 weeks, the subjects are given Mazdutide 2mg once weekly. If well tolerated, the dosage is increased to 4mg once weekly for another 4 weeks. If still well tolerated, the dosage is further increased to 6mg once weekly and maintained for the ensuing 16 weeks.', 'armGroupLabels': ['Mazdutide Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LIANGSHAN MU, MD, PhD', 'role': 'CONTACT', 'email': 'mu.liangshan@zs-hospital.sh.cn', 'phone': '02164041990', 'phoneExt': '695904'}, {'name': 'JINGJING JIANG, MD, PhD', 'role': 'CONTACT', 'email': 'jiang.jingjing@zs-hospital.sh.cn', 'phone': '02164041990', 'phoneExt': '692023'}, {'name': 'Xi Dong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'LIANGSHAN MU, MD, PhD', 'role': 'CONTACT', 'email': 'mu.liangshan@zs-hospital.sh.cn', 'phone': '02164041990', 'phoneExt': '695904'}, {'name': 'JINGJING JIANG, MD, PhD', 'role': 'CONTACT', 'email': 'jiang.jingjing@zs-hospital.sh.cn', 'phone': '02164041990', 'phoneExt': '692023'}], 'overallOfficials': [{'name': 'XI DONG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}