Back to resultsA Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
Primary Purpose
Obesity
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Pediatrics, Obesity, Chronic weight management
Eligibility Criteria
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
Sites / Locations
- Atlanta Center of Medical ResearchRecruiting
- Lynn Health Science InstituteRecruiting
- Baylor College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tirzepatide
Placebo
Arm Description
Tirzepatide administered subcutaneously (SC)
Placebo administered SC
Outcomes
Primary Outcome Measures
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
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
PK: Maximum Concentration (Cmax) of Tirzepatide
PK: Cmax of tirzepatide
Full Information
NCT ID
NCT05696847
First Posted
January 17, 2023
Last Updated
October 10, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05696847
Brief Title
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
Official Title
A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 Years to 11 Years) With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
November 13, 2024 (Anticipated)
Study Completion Date
November 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Pediatrics, Obesity, Chronic weight management
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Tirzepatide administered subcutaneously (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through Week 13
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide
Description
PK: AUC0-tau of tirzepatide
Time Frame
Predose up to 168 hours postdose
Title
PK: Maximum Concentration (Cmax) of Tirzepatide
Description
PK: Cmax of tirzepatide
Time Frame
Predose up to 168 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta Center of Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331 2012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
404-881-5800
First Name & Middle Initial & Last Name & Degree
R RIESENBERG
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
405-602-3939
First Name & Middle Initial & Last Name & Degree
Carl Griffin
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2600
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
713-798-0391
First Name & Middle Initial & Last Name & Degree
Stephanie Sisley
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
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