Effect of LY3502970 Versus Placebo in Participants with Obesity or Overweight with Weight-Related Diseases
- Conditions
- Obesity and Overweight with Weight-Related ComorbiditiesMedDRA version: 20.0Level: LLTClassification code 10029885Term: Obesity, unspecifiedSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2021-002805-88-HU
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
• Have a body mass index (BMI) of =30-kilogram per square meter (kg/m²)
• =27 kg/m² and <30 kg/m² with at least 1 of the following weight-related comorbidities
• Have hypertension, or dyslipidemia
• Have cardiovascular disease: (for example, ischemic cardiovascular disease
• Have obstructive sleep apnea (only in participants >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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- To compare the effect of QD LY3502970 versus placebo on waist circumference<br>- To assess safety and tolerability of study interventions<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - Percent change in body weight from baseline at Week 36<br>- Change in body weight (kg) from baseline at Week 26 and Week 36<br>- Percentage of study participants who achieve<br> =5% body weight reduction<br> =10% body weight reduction<br> at Week 26 and Week 36<br>- Change in BMI (kg/m2) from baseline at Week 26 and Week 36<br>- Change in waist circumference from baseline at Week 26 and Week 36<br>- Adverse events overall<br>- Adverse events of special interest<br>- Laboratory parameters<br>- Electrocardiogram<br>- Vital signs<br>- Population pharmacokinetics parameters;Timepoint(s) of evaluation of this end point: Week 26 and 36 of the study