RightFit
RecruitingPhase 3

A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and 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 compared with a placebo (a treatment with no active drug). It is for people who still have obesity or overweight while on steady weekly incretin treatment, with or without type 2 diabetes. The study lasts about 80 weeks.

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.

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

Eligibility

Who can join

  • Are on steady incretin treatment when checked for the study. Incretins are medicines used to manage blood sugar or weight.
  • Have a body mass index (BMI, a measure based on height and weight) of 30 or higher, or 27 or higher with at least one of the health problems listed below.
  • If your BMI is 27 to under 30, have high blood pressure, unhealthy blood fat levels, sleep apnea (breathing stops and starts during sleep), heart or blood vessel disease, or type 2 diabetes.
  • Have a steady body weight, with less than a 5% change when checked for the study.

Who can't join

  • Have had or plan to have weight-loss surgery. Liposuction, fat freezing, or a tummy tuck is allowed if done more than 1 year before the study check.
  • Have had or plan to have a weight-loss procedure using a scope (a tube used to see inside the body) or a device. Past device treatment is allowed if the device was removed more than 6 months before the study check.
  • Have type 1 diabetes.
  • Have taken insulin, DPP-4 inhibitors, or amylin analogs (types of blood sugar medicines) within 90 days before the study check.
  • Within 90 days before the study check, had a heart attack, stroke, a 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.

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

Official eligibility criteria

Inclusion Criteria: * Are on stable incretin therapy at screening * With persistent obesity or overweight defined as: * ≥30 kg/m2 OR * ≥27 kg/m2 with at least one existing obesity related complication at screening: * hypertension * dyslipidemia * obstructive sleep apnea * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or * type 2 diabetes * Have a stable body weight (\<5% body weight change) at screening 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 * Have taken any of the following antihyperglycemic medications within 90 days before screening: * dipeptidyl peptidase-4 (DPP-4) inhibitors * amylin analogs * insulin * 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

Study sites (59)

AL

AZ

CA

CT

FL

GA

IA

ID

IL

KS

KY

LA

  • IMA Clinical Research Monroe - Armand · Monroe, LA 71201Clinton Guillory · Principal investigatorMore trials in Monroe

MA

MD

MI

MO

NC

NY

OH

PA

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) · Pittsburgh, PA 15236 · Study contact · 412-650-6155Bryce Palchick · Principal investigatorMore trials in Pittsburgh

SC

TX