Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT03376802
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729667', 'term': 'SAR425899'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2017-12-12', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep energy expenditure', 'timeFrame': 'Baseline to Day 19', 'description': 'Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo'}], 'secondaryOutcomes': [{'measure': 'Total daily energy expenditure', 'timeFrame': 'Baseline to Day 19', 'description': 'Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo'}, {'measure': 'Resting energy expenditure', 'timeFrame': 'Baseline to Day 19', 'description': 'Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo'}, {'measure': 'Basal energy expenditure', 'timeFrame': 'Baseline to Day 19', 'description': 'Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo'}, {'measure': 'Respiratory quotient (RQ)', 'timeFrame': 'Baseline to Day 19', 'description': 'Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo'}, {'measure': 'Fat mass and fat-free mass', 'timeFrame': 'Baseline to Day 20', 'description': 'Change of fat mass and fat-free mass by dual energy X-ray absorptiometry (DEXA) scan from baseline to Day 20 with SAR425899 or placebo'}, {'measure': 'Diet Induced Thermogenesis (DIT)', 'timeFrame': 'Baseline to Day 19', 'description': 'Change of DIT from baseline to Day 19 with SAR425899 or placebo'}, {'measure': 'Fasting plasma glucose', 'timeFrame': '20 days', 'description': 'Change of FPG over time with SAR425899 or placebo'}, {'measure': 'HbA1c', 'timeFrame': 'Baseline to Day 20', 'description': 'Change of HbA1c from baseline to Day 20 with SAR425899 or placebo'}, {'measure': 'Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)', 'timeFrame': '20 days', 'description': 'Change of lipid biomarkers over time with SAR425899 or placebo'}, {'measure': 'Ketone bodies', 'timeFrame': '20 days', 'description': 'Change of ketone bodies over time with SAR425899 or placebo'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 27 days', 'description': 'Number of adverse events in patients under treatment with SAR425899 or placebo'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'Day 16', 'description': 'Assessment of SAR425899: time to reach Cmax (tmax)'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'Day 16', 'description': 'Assessment of SAR425899: maximum plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'Day 16', 'description': 'Assessment of SAR425899: area under the concentration versus time curve (AUC)'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'Day 16', 'description': 'Assessment of SAR425899: terminal elimination half-life (t1/2)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899.\n\nSecondary Objectives:\n\n* To assess the change in resting, basal and total daily energy expenditure.\n* To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation.\n* To assess the change in body composition and core temperature.\n* To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c).\n* To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses.\n* To assess the safety and tolerability.', 'detailedDescription': 'Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Overweight to obese male and female subjects.\n* Body mass index 28 - 40 kg/m2.\n* 18 to 50 years of age\n* Fasting plasma glucose ≤125 mg/dL.\n* Glycated hemoglobine (HbA1c) ≤6.5%.\n* Obesity associated mild concomitant diseases allowed (eg, mild hypertension, mild hypercholesteremia, and hyperlipidemia).\n* No concomitant medication allowed except stable treatment with statins or antihypertensive drugs (except ß-blocker).\n* Females should be either postmenopausal, or, if perimenopausal should have a normal regular menstrual cycle and should start or continue stable treatment with a monophasic oral contraceptive.\n\nExclusion criteria:\n\n* Elevated liver enzymes, lipase, amylase, or calcitonin at screening.\n* Current participation in an organized diet / weight reduction program or clinical trial of weight control or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening.\n* Any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy or hysterectomy.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03376802', 'briefTitle': 'A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Repeated Subcutaneous Doses of SAR425899 on Energy Expenditure and Safety in Overweight to Obese Male and Female Subjects', 'orgStudyIdInfo': {'id': 'PDY15012'}, 'secondaryIdInfos': [{'id': 'U1111-1191-5658', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAR425899', 'description': 'Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days', 'interventionNames': ['Drug: SAR425899']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Repeated once daily SC doses of placebo administered over 19 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SAR425899', 'type': 'DRUG', 'description': 'Pharmaceutical form: Solution for injection\n\nRoute of administration: Subcutaneous', 'armGroupLabels': ['SAR425899']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Solution for injection\n\nRoute of administration: Subcutaneous', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8400001', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 8400002', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}