EUCTR2024-000081-22-Outside-EU/EEA
Active, not recruiting
Phase 1
A Safety, Tolerability and Pharmacokinetic Study of Tirzepatide for the Treatment of Pediatric Participants (6 years to 11 years) with Obesity. - A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity
ConditionsWeight managementMedDRA version: 20.0Level: HLTClassification code 10027428Term: Metabolic disorders NECSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
DrugsMounjaro
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Weight management
- Sponsor
- Eli Lilly and Company
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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\.
- •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
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
Outcomes
Primary Outcomes
Not specified
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