RecruitingPhase 3

A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well eloralintide works and how safe it is for adults with obesity or overweight who do not have type 2 diabetes. The main study lasts about 75 weeks. People with prediabetes (blood sugar above normal but below the diabetes range) will continue for another 2 years.

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a BMI (a measure of weight compared with height) of 30, or 27 with at least one weight-related condition: high blood pressure, unhealthy blood fat levels, sleep apnea (breathing that stops and starts during sleep), or heart disease.
  • Have a steady weight, with less than a 5% change in the 90 days before screening.
  • Have tried at least one diet to lose weight that did not work.

Who can't join

  • Have had or plan to have surgery for obesity. Liposuction, fat freezing, or a tummy tuck is allowed if done more than 1 year before screening.
  • Have had or plan to have a weight-loss procedure using a tube passed into the stomach or a weight-loss device. A past device is allowed if it was removed more than 6 months before screening.
  • Have type 1 or type 2 diabetes.
  • In the 90 days before screening, had a heart attack, stroke, procedure to restore blood flow to the heart, unstable angina (new or worsening heart-related chest pain), or a hospital stay for heart failure.
  • Have or have had Class IV heart failure, the most severe class of heart failure.
  • Have used medicines or alternative remedies meant for weight loss in the 90 days before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Have Body Mass Index (BMI) at screening of the following: * 30 kilogram per square meter (kg/m2) OR * 27 kg/m2 with at least one of the following weight-related health conditions at screening: * high blood pressure * dyslipidemia * obstructive sleep apnea, or * heart disease * Have a stable body weight (\<5% body weight change) for 90 days prior to screening. * Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight Exclusion Criteria: * Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>1 year before screening) * Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening) * Have type 1 diabetes or type 2 diabetes * Have had within 90 days prior to screening: * heart attack * stroke * coronary artery revascularization * unstable angina, or * hospitalization due to congestive heart failure * Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure * Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Study sites (41)

AL

AZ

CA

CT

FL

GA

HI

IA

KS

LA

MA

MD

MI

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division · Troy, MI 48098 · Study contact · 248-312-0025Neil Fraser · Principal investigatorMore trials in Troy

NC

NJ

NM

NV

NY

PA

SC

TN

TX

VA