Weight management MedDRA version: 20.0 Level: HLT Classification code 10027428 Term: Metabolic disorders NEC System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Mounjaro
Zepbound (US only)
Product Name: Tirzepatide
Product Code: LY3298176
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solutio
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion 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
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 |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): PK: AUC0-tau of tirzepatide PK: Cmax of tirzepatide;Timepoint(s) of evaluation of this end point: Predose up to 168 hours postdose | — |
Countries
United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed