Efficacy and Safety of Eloralintide in Adults With Persistent Obesity or Overweight Treated With a Weekly Incretin: A Phase 3, Randomized, Placebo-Controlled Study

The primary objective of this study is to evaluate the efficacy of eloralintide compared to placebo regarding the mean change in body weight in adults with obesity or overweight who are receiving weekly incretin therapy. The investigation includes participants with and without type 2 diabetes.

This study involves 664 patients categorized into both male and female groups. The study population consists of individuals characterized by overweight or obesity. Participants must be on stable incretin therapy at the time of screening and must demonstrate a stable body weight, defined as a change of less than 5%. Inclusion requires a body mass index of ≥30 kg/m² or ≥27 kg/m² accompanied by at least one complication such as hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or type 2 diabetes. The subjects fall within the specified age ranges of 3 and 4.

This Phase 3, randomized, double-blind, placebo-controlled study is designed to investigate the efficacy and safety of weekly subcutaneous administration of eloralintide in adults with obesity or overweight who are receiving stable incretin therapy. The primary objective is to demonstrate the superiority of eloralintide compared to placebo regarding the percent change from baseline in body weight at Week 64. Participants must meet specific criteria, including a body mass index of $\ge$30 kg/m$^2$ or $\ge$27 kg/m$^2$ with at least one obesity-related complication, such as hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or type 2 diabetes. The study involves a screening visit to confirm stable weight and therapy status, followed by treatment intervals and a final assessment at the end of the study period. The total duration of participant involvement is estimated to extend through the completion of the 64-week observation period.

Eloralintide, containing the active substance ly3841136 sodium, is administered as a solution for injection in a pre-filled syringe via subcutaneous route. The investigational product is intended for weekly administration.

A placebo designed to match the appearance of the investigational product is utilized as a comparator in this study.

The efficacy of eloralintide will be evaluated based on the percent change from baseline in body weight. This primary endpoint will be measured at baseline and at week 64 to demonstrate superiority over placebo in adult participants with obesity or overweight.