Safety, Tolerability and Pharmacokinetics of Tirzepatide in Pediatric Participants with Obesity.
- Conditions
- Weight managementMedDRA version: 20.0Level: HLTClassification code 10027428Term: Metabolic disorders NECSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2024-000081-22-Outside-EU/EEA
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide<br><br>PK: Maximum Concentration (Cmax) of Tirzepatide;Primary end point(s): A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module;Timepoint(s) of evaluation of this end point: Baseline through Week 13
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PK: AUC0-tau of tirzepatide<br><br>PK: Cmax of tirzepatide;Timepoint(s) of evaluation of this end point: Predose up to 168 hours postdose