Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT06313528
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2024-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729679', 'term': 'retatrutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Sponsor-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)', 'timeFrame': 'Baseline up to Week 17 (inclusive)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Sleep Metabolic Rate (SMR)', 'timeFrame': 'Baseline up to Week 16 (inclusive)', 'description': 'In participants who achieve target weight loss'}, {'measure': 'Change from Baseline in SMR', 'timeFrame': 'Baseline up to Week 16 (inclusive)'}, {'measure': 'Change from Baseline in 24-hour Energy Expenditure (EE)', 'timeFrame': 'Baseline up to Week 16 (inclusive)', 'description': 'In participants who achieve target weight loss'}, {'measure': 'Change from Baseline in 24-hour EE', 'timeFrame': 'Baseline up to Week 16 (inclusive)'}, {'measure': 'Change from Baseline in Total Calorie Intake at Lunch', 'timeFrame': 'Baseline up to Week 17 (inclusive)'}, {'measure': 'Change from Baseline in Total Calorie Intake at Dinner', 'timeFrame': 'Baseline up to Week 17 (inclusive)'}, {'measure': 'Change from Baseline in Fasting Appetite Visual Analog Score (VAS)', 'timeFrame': 'Baseline up to Week 16 (inclusive)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food', 'Diet'], 'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/468355', 'label': 'A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI greater than 30 kg/m2\n* History of at least 1 self-reported unsuccessful dietary effort to reduce body weight\n\nExclusion Criteria:\n\n* Change in body weight of greater than 5 kg (11 pounds) within 3 months prior to start of study\n* Any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period: liposuction, cryolipolysis, or abdominoplasty\n* Prior or planned bariatric or gastric sleeve surgery, endoscopic therapy, or device-based therapy for obesity\n* Type 1 or Type 2 Diabetes, history of ketoacidosis, or hyperosmolar state\n* Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2\n* Acute or chronic hepatitis\n* Had within 90 days prior: acute myocardial infarction, cerebrovascular accident (stroke), coronary artery revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure\n* History of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years prior\n* History of chronic or acute pancreatitis\n* Blood transfusion or severe blood loss within the last 3 months or hemoglobinopathy, hemolytic anemia, sickle cell anemia\n* Clinically significant multiple or severe drug allergies\n* Started treatment with or changed dose within 12 months prior any medications that are associated with significant weight gain\n* History of substance use disorder'}, 'identificationModule': {'nctId': 'NCT06313528', 'briefTitle': 'A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Phase 1 Study to Investigate the Effect of LY3437943 Versus Placebo on Calorie Intake and Energy Expenditure in Participants With Obesity Under Calorie Restriction', 'orgStudyIdInfo': {'id': '18726'}, 'secondaryIdInfos': [{'id': 'J1I-MC-GZBW', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3437943', 'description': 'LY3437943 administered subcutaneously (SC)', 'interventionNames': ['Drug: LY3437943']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'LY3437943', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3437943']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}