Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT06970405
Status:
WITHDRAWN
Last Update Posted:
2025-09-17
First Post:
2025-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-05-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Through Week 32'}, {'measure': 'Severity of TEAEs', 'timeFrame': 'Through Week 32'}], 'secondaryOutcomes': [{'measure': 'Change in serum Follicle Stimulating Hormone (FSH) level in response to gonadotropin-releasing hormone (GnRH) injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Percent change in serum FSH level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Change in serum Luteinizing Hormone (LH) level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Percent change in serum LH level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Change in serum total testosterone level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Percent change in serum total testosterone level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Change in serum free testosterone level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Percent change in serum free testosterone level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Change in serum estradiol level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Percent change in serum estradiol level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Change in serum 17-hydroxyprogesterone (17-OHP) level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Percent change in serum 17-OHP level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Change in serum Dehydroepiandrosterone Sulphate (DHEA-S) level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Percent change in serum DHEA-S level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Change in serum androstenedione level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Percent change in serum androstenedione level in response to GnRH injection', 'timeFrame': 'Pre-GnRH Baseline, Through Week 20 Post-GnRH'}, {'measure': 'Change in cortisol level in response to Adrenocorticotropic Hormone (ACTH) level injection', 'timeFrame': 'Pre-ACTH Baseline, Through Week 20 post-ACTH'}, {'measure': 'Percent change in cortisol level in response to ACTH injection', 'timeFrame': 'Pre-ACTH Baseline, Through Week 20 post-ACTH'}, {'measure': 'Concentrations of garetosmab in serum', 'timeFrame': 'Through Week 32'}, {'measure': 'Concentrations of total activin A in serum', 'timeFrame': 'Through Week 32'}, {'measure': 'Change in bleeding time', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Percent change in bleeding time', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Change in thrombin time', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Percent change in thrombin time', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Change in Activated Partial Thromboplastin Time (aPTT)', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Percent change in aPTT', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Change in Prothrombin Time (PT)', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Percent change in PT', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Change in International Normalized Ratio (INR)', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Percent change in INR', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Change in platelets count', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Percent change in platelets count', 'timeFrame': 'Baseline, At Week 8'}, {'measure': 'Change in serum ACTH level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum ACTH level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum FSH level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum FSH level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum LH level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum LH level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum Thyroid Stimulating Hormone (TSH) level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum TSH level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum Thyroxine (T4) level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum T4 level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum total testosterone level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum total testosterone level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum free testosterone level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum free testosterone level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum 17-OHP level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum 17-OHP level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum estradiol level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum estradiol level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum DHEA-S level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum DHEA-S level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum androstenedione level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum androstenedione level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum Human Growth Hormone (HGH) level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum HGH level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum Insulin-like Growth Factor (IGF)-1 level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum IGF-1 level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Change in serum cortisol level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Percent change in serum cortisol level', 'timeFrame': 'Baseline, Through Week 20'}, {'measure': 'Incidence of Anti-Drug Antibodies (ADA) to garetosmab', 'timeFrame': 'Through Week 32'}, {'measure': 'Titer of ADA to garetosmab', 'timeFrame': 'Through Week 32'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy', 'Postmenopausal'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on otherwise healthy participants with obesity.\n\nThe aim of the study is to see how safe and tolerable the study drug is.\n\nThe study is looking at several other research questions, including:\n\n* How much study drug is in the blood at different times\n* What effect the study drug has on the blood clotting\n* What effect the study drug has on hormone levels\n* What effect the study drug has on some organs that produce hormones\n* What effect hormones have on the side effects produced by the study drug\n* Whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Participants with obesity (defined as Body Mass Index (BMI) ≥30 kg/m2) who are otherwise healthy, as defined in the protocol\n2. Women must be postmenopausal, as defined in the protocol\n3. Serum testosterone within age-adjusted normal range for men at screening\n4. The platelet count is within the normal lower and upper laboratory range\n\nKey Exclusion Criteria:\n\n1. Patients diagnosed with Type 1 or Type 2 diabetes, as defined in the protocol\n2. History of any severe, non-traumatic bleeding, and or a known pre-existing medical history of a bleeding, as defined in the protocol\n3. History of clinically significant cardiovascular (eg, uncontrolled blood pressure), endocrine, respiratory, hepatic, renal, gastrointestinal, hematological, psychiatric, or neurological disease, as defined in the protocol\n4. Any malignancy in the last 5 years prior to screening visit, except for non-melanoma skin cancer that have been resected with no evidence of metastatic disease\n5. Any chronic active infection or has received anti-Hepatitis C Virus (HCV) treatments within the previous 6 months, as defined in the protocol\n6. Antiplatelet therapy (eg clopidogrel, aspirin), anticoagulants (eg, warfarin, heparin, factor Xa inhibitor, or thrombin inhibitors) in the last 90 days or within 5 half-lives of the therapy at screening, whichever is longer\n7. Use in the previous 90 days for \\>7 consecutive days at screening of anti-obesity medications, anabolic agents, systemic steroids, androgens, estrogens, or progestogens. Chronic stable doses of thyroid hormones in participants with normal thyroid function are allowed\n8. For women, current use, or past use in the last 90 days at screening of hormonal replacement or contraceptive therapy\n\nNOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply'}, 'identificationModule': {'nctId': 'NCT06970405', 'briefTitle': 'Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled Study of Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Garetosmab in Men and Post-Menopausal Women With Obesity Who Are Otherwise Healthy', 'orgStudyIdInfo': {'id': 'R2477-OB-2470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose', 'description': 'Randomized per the protocol', 'interventionNames': ['Drug: Garetosmab']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose', 'description': 'Randomized per the protocol', 'interventionNames': ['Drug: Garetosmab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Randomized per the protocol', 'interventionNames': ['Drug: Matching Placebo']}], 'interventions': [{'name': 'Garetosmab', 'type': 'DRUG', 'otherNames': ['REGN2477'], 'description': 'Administered per the protocol', 'armGroupLabels': ['High Dose', 'Low Dose']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'Administered per the protocol', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}