Obesity and Overweight with Weight-Related Comorbidities MedDRA version: 20.0 Level: LLT Classification code 10029885 Term: Obesity, unspecified System Organ Class: 100000004861
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Have a body mass index (BMI) of =30-kilogram per square meter (kg/m²) • =27 kg/m² and 30 years of age) • Have had a stable body weight for the 3 months prior to randomization (5% body weight gain and/or loss) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 216 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: • Have any prior diagnosis of Type 1 diabetes mellitus • Have a prior planned surgical treatment for obesity • Have obesity induced by other endocrinological disorders or diagnosed monogenetic or syndromic forms of obesity • Have renal impairment measured as estimated glomerular filtration rate (eGFR) • Have a history of acute chronic pancreatitis • Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, may be considered for inclusion if they are not on excluded medications. • Have poorly controlled hypertension • Have any acute myocardial infarction • Have cerebrovascular accident (stroke) • Hospitalization due to congestive heart failure (CHF) • Have cancer • Have human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening • Have hepatitis B and/or positive hepatitis B surface antigen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that at least one dose level of QD oral LY3502970 is superior in percent body weight reduction relative to placebo.;Secondary Objective: - To compare the effect of QD LY3502970 versus placebo on body weight - To compare the effect of QD LY3502970 versus placebo on waist circumference - To assess safety and tolerability of study interventions - To assess the PK of LY3502970 and potential participant factors that may influence its PK;Primary end point(s): Percent change in body weight from baseline at Week 26;Timepoint(s) of evaluation of this end point: Week 26 of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percent change in body weight from baseline at Week 36 - Change in body weight (kg) from baseline at Week 26 and Week 36 - Percentage of study participants who achieve =5% body weight reduction =10% body weight reduction at Week 26 and Week 36 - Change in BMI (kg/m2) from baseline at Week 26 and Week 36 - Change in waist circumference from baseline at Week 26 and Week 36 - Adverse events overall - Adverse events of special interest - Laboratory parameters - Electrocardiogram - Vital signs - Population pharmacokinetics parameters;Timepoint(s) of evaluation of this end point: Week 26 and 36 of the study | — |
Countries
Canada, Hungary, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed