Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT06075667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2023-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 72'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with ≥5% BMI Reduction', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change from Baseline in Waist Circumference', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change from Baseline in Systolic Blood Pressure', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change from Baseline in Diastolic Blood Pressure', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Percent Change from Baseline in Total Cholesterol', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change from Baseline in Fasting Glucose', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change from Baseline in Fasting Insulin', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide', 'timeFrame': 'Baseline through Week 72', 'description': 'AUC is presented as a single average measure of AUC across the study duration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/427361', 'label': 'A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.\n\nParticipants who have completed the primary 72-week GPHP study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR\n* Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.\n\n * dyslipidemia\n * pre-hypertension\n * hypertension\n * nonalcoholic fatty liver disease\n * obstructive sleep apnea\n * prediabetes\n * documented preexisting condition of Type 2 Diabetes\n\nParticipants with Type 2 Diabetes Mellitus (T2DM)\n\n* Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\\<9.0%\n\nExclusion Criteria:\n\n* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.\n* Have Type 1 Diabetes\n* Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.\n* Are prepubertal (Tanner stage 1).\n* Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2\n* Have a history of chronic or acute pancreatitis.\n* Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to\n\n * gastric bypass\n * sleeve gastrectomy\n * restrictive bariatric surgery, such as Lap-Band gastric banding, or\n * any other procedure intended to result in weight reduction.'}, 'identificationModule': {'nctId': 'NCT06075667', 'briefTitle': 'A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)', 'orgStudyIdInfo': {'id': '17365'}, 'secondaryIdInfos': [{'id': 'I8F-MC-GPHP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2023-504413-80-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirzepatide', 'description': 'Participants will receive tirzepatide subcutaneously (SC).', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tirzepatide', 'type': 'DRUG', 'otherNames': ['LY3298176'], 'description': 'Administered SC', 'armGroupLabels': ['Tirzepatide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'CenExel iResearch, LLC', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '83646', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Solaris Clinical Research', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': "Cotton O'Neil Diabetes & Endocrinology", 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Barry J. Reiner, MD, LLC', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'M Health Fairview - Delaware Clinical Research Unit (DCRU)', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45429', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'PriMED Clinical Research', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '372212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Health One Hundred Oaks', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'T6G 2E1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Diabetes Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L8L 5G8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Wharton Medical Clinic Clinical Trials Inc', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G7H 5H6', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CIUSSS- saguenay-Lac-Saint-Jean', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': '779 00', 'city': 'Olomouc', 'state': 'Olomoucký kraj', 'country': 'Czechia', 'facility': 'ReFit Clinic', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '703 84', 'city': 'Ostrava', 'state': 'Ostrava Město', 'country': 'Czechia', 'facility': 'Nemocnice AGEL Ostrava - Vitkovice a.s.', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '150 06', 'city': 'Prague', 'state': 'Praha 5', 'country': 'Czechia', 'facility': 'Fakultni nemocnice v Motole', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '58633', 'city': 'Jihlava', 'country': 'Czechia', 'facility': 'Nemocnice Jihlava', 'geoPoint': {'lat': 49.3961, 'lon': 15.59124}}, {'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '70300', 'city': 'Beer Yaacov', 'state': 'Central District', 'country': 'Israel', 'facility': 'Yitzhak Shamir Medical Center'}, {'zip': '4920235', 'city': 'Petah Tikva', 'state': 'Central District', 'country': 'Israel', 'facility': "Schneider Children's Medical Center", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '5262100', 'city': 'Ramat Gan', 'state': 'Central District', 'country': 'Israel', 'facility': 'Sheba Medical Center'}, {'zip': '9013102', 'city': 'Jerusalem', 'state': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '1834111', 'city': 'Afula', 'state': 'Northern District', 'country': 'Israel', 'facility': 'Emek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '3109601', 'city': 'Haifa', 'state': 'Northern District', 'country': 'Israel', 'facility': 'Rambam Health Care Campus'}, {'zip': '8410101', 'city': 'Beersheba', 'state': 'Southern District', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': "IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '37126', 'city': 'Verona', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '98125', 'city': 'Messina', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Di Messina G. Martino', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '02-117', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Instytut Diabetologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '41-800', 'city': 'Zabrze', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny nr 1 SUM', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'zip': '91-738', 'city': 'Lodz', 'state': 'Łódź Voivodeship', 'country': 'Poland', 'facility': 'Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Uniwersyteckie Centrum Pediatrii im. M. Konop -T', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], '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': {'url': 'http://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}