Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT03466203
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2018-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of LLF580 in Obese Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], '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'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, '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': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2018-02-09', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580', 'timeFrame': '12 weeks', 'description': 'To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'LDL-C, HDL-C', 'timeFrame': '12 weeks', 'description': 'To assess the effects of LLF580 on lipid profiles.'}, {'measure': 'serum CTX-1, P1NP, and osteocalcin', 'timeFrame': '12 weeks', 'description': 'To assess the potential effects of LLF580 on these biomarkers.'}, {'measure': 'Body weight', 'timeFrame': '12 weeks', 'description': 'To assess the effects of LLF580 on weight.'}, {'measure': 'BMI', 'timeFrame': '12 weeks', 'description': 'To assess the effects of LLF580 on BMI'}, {'measure': 'serum BSAP', 'timeFrame': '12 weeks', 'description': 'To assess the potential effects of LLF580 on these biomarkers.'}, {'measure': 'urine NTX-1', 'timeFrame': '12 weeks', 'description': 'To assess the potential effects of LLF580 on these biomarkers.'}, {'measure': 'Total cholesterol', 'timeFrame': '12 weeks', 'description': 'To asses the effects of LLF580 on lipid profiles'}, {'measure': 'Triglycerides (fasting)', 'timeFrame': '12 weeks', 'description': 'To assess the effects of LLF580 on lipid profiles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'hypertriglyceridemia'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '34431493', 'type': 'DERIVED', 'citation': 'Rader DJ, Maratos-Flier E, Nguyen A, Hom D, Ferriere M, Li Y, Kompa J, Martic M, Hinder M, Basson CT, Yowe D, Diener J, Goldfine AB; CLLF580X2102 Study Team. LLF580, an FGF21 Analog, Reduces Triglycerides and Hepatic Fat in Obese Adults With Modest Hypertriglyceridemia. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e57-e70. doi: 10.1210/clinem/dgab624.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17731', 'label': 'Results for CLLF580X2102 can be found on the Novartis Clinical Trial Results Website'}, {'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=649', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and tolerability of multiple doses of LLF580 administered subcutaneously over 3 months in obese subjects. In addition, the study will also determine early efficacy signals in various metabolic diseases associated with elevated triglycerides and/or obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) within the range of 30 to 45 kg/m2, inclusive, with ethnic adjustment (≥27.5 kg/m2 for Asian individuals).\n* Fasting triglyceride 150 - 500 mg/dL (1.69 - 5.65 mmol/L), inclusive, at screening.\n* Able to communicate well with the investigator, to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* History of hepatobilliary disease.\n* Liver disease or liver injury as indicated by abnormal liver function tests.\n* Chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).\n* Fasting triglycerides greater than or equal to 500 mg/dL \\[5.65 mmol/L\\], or concomitant use of drug treatment for hypertriglyceridemia (fibrates, omega-3 fatty acids, nicotinic acid).\n* History of pancreatic injury or pancreatitis.\n* History of hypersensitivity to drugs of similar biological class, FGF21 protein analogue, or Fc fusion proteins.\n* History of bone disorders or low vitamin D level.\n* Contraindications to MRI.\n* Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months).\n* Use of weight loss drugs.\n* Enrollment in a diet, weight loss or exercise programs.'}, 'identificationModule': {'nctId': 'NCT03466203', 'briefTitle': 'Safety Study of LLF580 in Obese Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580', 'orgStudyIdInfo': {'id': 'CLLF580X2102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LLF580', 'description': 'LLF580 every 28 days \\* 3', 'interventionNames': ['Biological: LLF580']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to LLF580 every 28 days \\* 3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LLF580', 'type': 'BIOLOGICAL', 'description': 'LLF580 300mg', 'armGroupLabels': ['LLF580']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to LLF580', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '27265', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}