Obesity
Conditions
Keywords
Pediatrics, Obesity, Chronic weight management
Brief summary
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.
Interventions
DRUGTirzepatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Male and female participants with body mass index (BMI) ≥ the 95th percentile for age and sex * Have failed to achieve adequate weight loss through lifestyle modification in the investigator's opinion * Female participants only: Determined as prepubertal Tanner Stage 1.
Exclusion criteria
* Change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity * Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis; or have other GI disorders * Have a known clinically significant gastric emptying, have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surger, or have endoscopic or device-based therapy for obesity or have had device removal within the last 6 months. * Have confirmed type 1 or type 2 diabetes mellitus * Have a history or current cerebrovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the IP; or may interfere with the interpretation of data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | Baseline through Week 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) 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. | PK: AUC0-tau of tirzepatide was reported. |
| PK: Maximum Concentration (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. | PK: Cmax of tirzepatide |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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 mg tirzepatide administered SC QW during Weeks 1 to 4 followed by 5 mg tirzepatide during Weeks 5 to 8. | 6 |
| 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. | 2 |
| 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. | 7 |
| 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. | 3 |
| 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. | 7 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Sponsor Decision | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Parent/Guardian | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | Cohort 2: Placebo (BW <50 kg) | Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Cohort 1: Placebo (BW >=50 kg) | Cohort 3: Placebo (BW 40 to 60 kg) | Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 6 Participants | 2 Participants | 7 Participants | 2 Participants | 3 Participants | 7 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 5 Participants | 2 Participants | 5 Participants | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 4 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 2 Participants | 0 Participants | 5 Participants | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 27 Participants | 6 Participants | 2 Participants | 7 Participants | 2 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 17 Participants | 3 Participants | 2 Participants | 5 Participants | 1 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 7 | 0 / 3 | 0 / 7 |
| other Total, other adverse events | 0 / 2 | 5 / 6 | 0 / 2 | 6 / 7 | 1 / 3 | 7 / 7 |
| serious Total, serious adverse events | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 7 | 0 / 3 | 0 / 7 |
Outcome results
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.
Time frame: Baseline through Week 14
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: Placebo (BW >=50 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAE | 0.0 Percentage of participants |
| Cohort 1: Placebo (BW >=50 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAE | 0.0 Percentage of participants |
| Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAE | 83.3 Percentage of participants |
| Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAE | 0.0 Percentage of participants |
| Cohort 2: Placebo (BW <50 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAE | 0.0 Percentage of participants |
| Cohort 2: Placebo (BW <50 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAE | 0.0 Percentage of participants |
| Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAE | 85.7 Percentage of participants |
| Cohort 2: 1.25-2.5 mg Tirzepatide (BW <50 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAE | 0.0 Percentage of participants |
| Cohort 3: Placebo (BW 40 to 60 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAE | 33.3 Percentage of participants |
| Cohort 3: Placebo (BW 40 to 60 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAE | 0.0 Percentage of participants |
| Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAE | 100.0 Percentage of participants |
| Cohort 3: 2.5-5 mg Tirzepatide (BW 40 to 60 kg) | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAE | 0.0 Percentage of participants |
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.
Time frame: 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.
Population: All participants who received at least one dose of tirzepatide and had evaluable PK data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Placebo (BW >=50 kg) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide | 105000 nanogram *hour per milliliter (ng*h/mL) | Standard Deviation 33100 |
| Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide | 80800 nanogram *hour per milliliter (ng*h/mL) | Standard Deviation 9580 |
| Cohort 2: Placebo (BW <50 kg) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide | 156000 nanogram *hour per milliliter (ng*h/mL) | Standard Deviation 22500 |
Secondary
PK: Maximum Concentration (Cmax) of Tirzepatide
PK: Cmax of tirzepatide
Time frame: 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.
Population: All participants who received at least one dose of tirzepatide and had evaluable PK data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Placebo (BW >=50 kg) | PK: Maximum Concentration (Cmax) of Tirzepatide | 884 nanograms per milliliter (ng/mL) | Standard Deviation 243 |
| Cohort 1: 2.5-5 mg Tirzepatide (BW >=50 kg) | PK: Maximum Concentration (Cmax) of Tirzepatide | 674 nanograms per milliliter (ng/mL) | Standard Deviation 63.8 |
| Cohort 2: Placebo (BW <50 kg) | PK: Maximum Concentration (Cmax) of Tirzepatide | 1280 nanograms per milliliter (ng/mL) | Standard Deviation 194 |