A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

Phase 2CompletedNCT05051579

Eli Lilly and Company272 enrolled

Overview

The main purpose of the study was to assess the effect of LY3502970 in participants who have obesity or are overweight.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

272

Conditions

Obesity Overweight and Obesity

Interventions

LY3502970DRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²) * Have a BMI ≥27 kg/m² and \<30 kg/m² with at least 1 of the following weight-related comorbidities eg; \[Have hypertension, or dyslipidemia, cardiovascular disease\] * Have had a stable body weight for the 3 months prior to randomization (not more than 5% body weight gain and/or loss) Exclusion Criteria: * Have any prior diagnosis of diabetes * Have a prior or 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) \<30 milliliter (mL)/minute (min)/1.73 m² * 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. Within 3 months prior to screening: * Have poorly controlled hypertension * Have history of acute myocardial infarction * Have history of cerebrovascular accident (stroke) * Had 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

Locations (35)

Outcomes

Primary Outcomes

Percent Change From Baseline in Body Weight in LY3502970 and Placebo

Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.

Time frame: Baseline, Week 26

Secondary Outcomes

Percent Change From Baseline in Body Weight in LY3502970 and Placebo

LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.

Time frame: Baseline, Week 36

Change From Baseline in Body Weight in LY3502970 and Placebo

Time frame: Baseline, Week 26

Change From Baseline in Body Weight in LY3502970 and Placebo

Time frame: Baseline, Week 36

Change From Baseline in Waist Circumference in LY3502970 and Placebo

Data from ClinicalTrials.gov

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