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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPHV | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of tirzepatide (LY3298176) in pediatric participants with obesity. The blood tests will be performed to investigate how the body processes the study drug in these participants. For each participant, the study will last about approximately 13 weeks excluding the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Placebo (BW >=50 kg) | Placebo Comparator | Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8. |
|
| Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | Experimental | Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8. |
|
| Cohort 2: Placebo (BW <50 kg) | Placebo Comparator | Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8. |
|
| Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Experimental | Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8. |
|
| Cohort 3: Placebo (BW 40 to 60 kg) | Placebo Comparator | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | Percentage of participants with TEAEs and SAEs were reported here. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record. | Baseline through Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide | PK: AUC0-tau of tirzepatide was reported. | Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Center of Medical Research | Atlanta | Georgia | 30331 2012 | United States | ||
| Lynn Health Science Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Placebo (BW >=50 kg) | Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8. |
| FG001 | Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8. |
| FG002 | Cohort 2: Placebo (BW <50 kg) | Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8. |
| FG003 | Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8. |
| FG004 | Cohort 3: Placebo (BW 40 to 60 kg) | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8. |
| FG005 | Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Placebo (BW >=50 kg) | Participants in this cohort had a screening body weight of at least 50 kg received placebo administered SC QW during Weeks 1 to 8. |
| BG001 | Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | Percentage of participants with TEAEs and SAEs were reported here. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record. | All participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | Baseline through Week 14 |
|
Baseline Up To 14 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Placebo (BW >=50 kg) | Participants in this cohort had a screening body weight of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) in Weeks 1 to 8. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2023 | Jul 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2024 | Jul 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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|
| Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) | Experimental | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8. |
|
|
| Placebo | Drug | Administered SC |
|
| PK: Maximum Concentration (Cmax) of Tirzepatide |
PK: Cmax of tirzepatide |
| Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6. |
| Oklahoma City |
| Oklahoma |
| 73112 |
| United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Withdrawal by Parent/Guardian |
|
| Adverse Event |
|
| Sponsor Decision |
|
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8.
| BG002 | Cohort 2: Placebo (BW <50 kg) | Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8. |
| BG003 | Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8. |
| BG004 | Cohort 3: Placebo (BW 40 to 60 kg) | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8. |
| BG005 | Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8. |
| BG006 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants in this cohort had a screening body weight of at least 50 kg received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8. |
| OG002 | Cohort 2: Placebo (BW <50 kg) | Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8. |
| OG003 | Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 2.5 mg tirzepatide during Weeks 5 to 8. |
| OG004 | Cohort 3: Placebo (BW 40 to 60 kg) | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW during Weeks 1 to 8. |
| OG005 | Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide | PK: AUC0-tau of tirzepatide was reported. | All participants who received at least one dose of tirzepatide and had evaluable PK data. | Posted | Mean | Standard Deviation | nanogram *hour per milliliter (ng*h/mL) | Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6. |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of Tirzepatide | PK: Cmax of tirzepatide | All participants who received at least one dose of tirzepatide and had evaluable PK data. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Predose on weeks 3, 6, 8; 12 and 24 hours post first dose; Within 24 to 96 hours post-dose at week 4; Within 120 to 168 hours post-dose at week 6. |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | Participants in this cohort had a screening body weight of at least 50 kg received 2.5 milligrams (mg) tirzepatide administered SC QW in Weeks 1 to 4 followed by 5 mg tirzepatide in Weeks 5 to 8. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | Cohort 2: Placebo (BW <50 kg) | Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW in Weeks 1 to 8. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Participants in this cohort had a screening body weight less than 50 kg received 1.25 mg tirzepatide administered SC QW in Weeks 1 to 4 followed by 2.5 mg tirzepatide in Weeks 5 to 8. | 0 | 7 | 0 | 7 | 6 | 7 |
| EG004 | Cohort 3: Placebo (BW 40 to 60 kg) | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received placebo administered SC QW in Weeks 1 to 8. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG005 | Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) | Participants in this cohort had a screening body weight between 40 to 60 kg, inclusive, received 2.5 mg tirzepatide administered SC QW in Weeks 1 to 4 followed by 5 mg tirzepatide in Weeks 5 to 8. | 0 | 7 | 0 | 7 | 7 | 7 |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |