Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-04 @ 7:44 PM
Study NCT ID:
NCT06277934
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'dispFirstSubmitDate': '2025-08-04', 'completionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-18', 'dispFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'Percent change in body weight', 'timeFrame': '12 weeks', 'description': 'Percent change in body weight from baseline at Week 12'}, {'measure': 'Change in body weight in kilogram', 'timeFrame': '12 weeks', 'description': 'Change in body weight from baseline at Week 12'}, {'measure': 'Percentage of participants who achieve ≥5% and ≥10% body weight reduction', 'timeFrame': '12 weeks', 'description': 'Percentage of participants who achieve ≥5% and ≥10% body weight reduction at Week 12'}, {'measure': 'Change in Body mass index (BMI) in kg/m^2', 'timeFrame': '12 weeks', 'description': 'Change in BMI from baseline at Week 12'}, {'measure': 'Change in waist circumference in centimetre', 'timeFrame': '12 weeks', 'description': 'Change in waist circumference from baseline at Week 12 .'}, {'measure': 'RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)', 'timeFrame': '12 weeks', 'description': 'Analysis of AUC0-last'}, {'measure': 'RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)', 'timeFrame': '12 weeks', 'description': 'Analysis of AUC0-inf'}, {'measure': 'RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)', 'timeFrame': '12 weeks', 'description': 'Analysis of Cmax'}, {'measure': 'RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)', 'timeFrame': '12 weeks', 'description': 'Analysis of Tmax'}, {'measure': 'RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)', 'timeFrame': '12 weeks', 'description': 'Analysis of t1/2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 75 years\n* Have a BMI ≥27 kg/m² and ≤ 45 kg/m²\n* Have had a stable body weight for the 3 months prior to randomization\n\nExclusion Criteria:\n\n* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity\n* Have a prior or planned surgical treatment for obesity\n* Have or plan to have endoscopic and/or device-based therapy for obesity\n* Have any prior diagnosis of diabetes\n* Have an electrocardiogram (ECG) with abnormalities\n* Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years\n* Have a history of suicide attempt.'}, 'identificationModule': {'nctId': 'NCT06277934', 'briefTitle': 'A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regor Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight With Weight-Related Comorbidities', 'orgStudyIdInfo': {'id': 'RGT001-075-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RGT001-075 Group', 'description': 'Patients will receive once daily dose of study drug for a total of 12 weeks', 'interventionNames': ['Drug: RGT001-075']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Patients will receive once daily dose of matching placebo for a total of 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RGT001-075', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['RGT001-075 Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '02818', 'city': 'East Greenwich', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 41.66038, 'lon': -71.45589}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regor Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}