Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT06867718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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': 236}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in body weight at Week 36', 'timeFrame': 'Baseline and 36 weeks', 'description': 'Least Squares (LS) mean using mixed model repeated measures (MMRM)'}], 'secondaryOutcomes': [{'measure': 'Percent change from baseline in body weight at Week 26', 'timeFrame': 'Baseline and 26 weeks', 'description': 'Least Squares (LS) mean using mixed model repeated measures (MMRM)'}, {'measure': 'Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall', 'timeFrame': 'Baseline through week 36', 'description': 'To evaluate the safety and tolerability of RGT001-075 for weight loss in adults who are obese, or overweight with at least one weight-related comorbidity'}, {'measure': 'Ambulatory Blood Pressure Monitoring (ABPM)', 'timeFrame': 'Baseline, 26 weeks', 'description': 'The ABPM device will be attached to the nondominant arm, and participants will be instructed to wear the monitor for a 24- to 27-hour period.'}, {'measure': 'AUC0-last', 'timeFrame': 'week 15', 'description': 'Area under the serum concentration curve from time-zero to the last quantifiable concentration of RGT001-075'}, {'measure': 'AUC0-inf', 'timeFrame': 'week 15', 'description': 'Area under curve from time zero to time infinite'}, {'measure': 'Cmax', 'timeFrame': 'week15', 'description': 'Maximum concentration of RT001-075'}, {'measure': 'Tmax', 'timeFrame': 'week 15', 'description': 'Time to achieve maximum concentration of RT001-075'}, {'measure': 't1/2', 'timeFrame': 'week 15', 'description': 'Terminal half-life of RGT001-075'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GLP-1 receptor agonist (GLP-1 RA)', 'Obesity'], 'conditions': ['Obesity or Overweight']}, 'descriptionModule': {'briefSummary': 'This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female, age 18-75 years (inclusive) at the time of signing informed consent.\n2. Hemoglobin A1c (HbA1c) \\<6.5% at screening.\n3. BMI ≥30 kg/m².\n4. BMI ≥27 kg/m² and \\<30 kg/m² with at least 1 weight-related comorbidity:\n\n * hypertension\n * dyslipidemia\n * cardiovascular (CV) disease\n * obstructive sleep apnea\n5. Have a stable body weight (\\< 5% change) for the 3 months prior to randomization.\n\nExclusion Criteria (Obesity Related):\n\n1. Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).\n2. Have a prior or planned surgical treatment for obesity.\n3. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months before screening such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner.\n4. Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.\n\nExclusion Criteria (Medical Conditions)\n\n1. Diabetes.\n2. Have a history of acute or chronic pancreatitis.\n3. Have current symptomatic gallbladder disease or biliary disease.\n4. Have known liver disease other than MASLD.\n5. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).\n6. Have a serum calcitonin ≥20 pg/mL.\n7. Have an eGFR \\<30 mL/min/1.73 m², as determined by the central laboratory at screening.\n8. Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.\n9. Have had any exposure to GLP-1 analogs, or other related compounds within the prior 3 months or any prior history of clinically significant side effects from GLP-1 receptor agonist (GLP-1 RA) or other related compounds containing GLP-1."}, 'identificationModule': {'nctId': 'NCT06867718', 'acronym': 'COMO-1', 'briefTitle': 'Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regor Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase 2 Study of Once-Daily RGT001-075 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities (COMO-1)', 'orgStudyIdInfo': {'id': 'RGT001-075-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RGT1', 'description': 'Study Drug: RGT001-075 (Dose 1)', 'interventionNames': ['Drug: RGT001-075']}, {'type': 'EXPERIMENTAL', 'label': 'RGT2', 'description': 'Study Drug: RGT001-075 (Dose 2)', 'interventionNames': ['Drug: RGT001-075']}, {'type': 'EXPERIMENTAL', 'label': 'RGT3', 'description': 'Study Drug: RGT001-075 (Dose 3)', 'interventionNames': ['Drug: RGT001-075']}, {'type': 'EXPERIMENTAL', 'label': 'RGT4', 'description': 'Study Drug: RGT001-075 (Dose 4)', 'interventionNames': ['Drug: RGT001-075']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'RGT001-075', 'type': 'DRUG', 'description': 'RGT001-075 is a small molecule GLP-1 agonist', 'armGroupLabels': ['RGT1', 'RGT2', 'RGT3', 'RGT4']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 30.69436, 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'Palm Springs Community Health Center', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32162', 'city': 'The Villages', 'state': 'Florida', 'country': 'United States', 'facility': 'Synexus Clinical Research', 'geoPoint': {'lat': 28.93408, 'lon': -81.95994}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Javara-Privia Medical Group, Georgia LLC', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '31792', 'city': 'Thomasville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Javara-Privia Medical Group, Georgia, LLC', 'geoPoint': {'lat': 30.83658, 'lon': -83.97878}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Synexus Clinical Research', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 41.47309, 'lon': 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40.60967, 'lon': -111.9391}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The Sponsor recognizes that sharing anonymized data and other information from clinical trials can enhance biomedical research. The Sponsor is following ongoing discussions among industry, academia, and other stakeholders regarding data sharing. Industry and academic partners hold various positions on the amount, types, and forms of data that will be useful l to the research community, the public, and the process for sharing. As a small, young company, the Sponsor awaits further guidance and input from industry participants on best practices before issuing a comprehensive data sharing plan. For now, Sponsor defers a description of what data will be shared and the process for doing so.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regor Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}