Clinical trial NCT05696847: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Pediatrics
Obesity
Chronic weight management
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline through Week 13
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of Tirzepatide
timeFrame: Predose up to 168 hours postdose
measure: PK: Maximum Concentration (Cmax) of Tirzepatide
timeFrame: Predose up to 168 hours postdose
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Center of Medical Research
state: Georgia
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Eli Lilly and Company
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
References: