Efficacy and Safety of Eloralintide in Adults with Obesity or Overweight without Type 2 Diabetes: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study

The primary objective of this study is to evaluate the efficacy of eloralintide in facilitating change in body weight compared to a placebo in adult participants with obesity or overweight without type 2 diabetes. This investigation aims to establish the superiority of the investigational agent in weight management for the specified patient population.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients categorized as having obesity or being overweight. Participants include both male and female individuals within specific age ranges. Eligible subjects must have maintained a stable body weight, defined as less than a 5% change, for 90 days preceding screening. Individuals classified as overweight are required to present with at least one comorbid condition, such as hypertension, hypercholesterolemia, obstructive sleep apnea, or heart disease. Additionally, a history of unsuccessful dietary effort for weight reduction must be reported.

This Phase 3 randomized, double-blind, placebo-controlled study is designed to investigate the efficacy and safety of eloralintide administered via subcutaneous use once weekly. The primary objective is to demonstrate the superiority of the investigational product compared to a placebo regarding the percent change from baseline in body weight. Participants must meet criteria for obesity or overweight, specifically requiring comorbid conditions such as hypertension, hypercholesterolemia, obstructive sleep apnea, or heart disease if categorized as overweight. Eligible individuals must have maintained a stable body weight for 90 days prior to screening and have a history of unsuccessful dietary weight loss efforts. The clinical trial involves a baseline assessment, followed by monitoring through week 64 to evaluate the primary endpoint. The study is estimated to conclude by April 2030.

Eloralintide is an experimental medication containing LY3841136 sodium. It is administered as a solution for injection in a pre-filled syringe via subcutaneous administration on a once weekly dosing schedule.

A placebo designed to match the appearance of the experimental treatment is utilized for comparison.

The primary efficacy endpoint is the percent change from baseline in body weight. Assessment of this parameter will occur at baseline and at week 64.