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Study of Once‑Weekly Eloralintide (LY3841136 Sodium) in Adults with Obesity or Overweight, Type 2 Diabetes, and High Cardiovascular Risk

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have Obesity or Overweight together with Type 2 Diabetes and an increased risk of Cardiovascular disease. Participants will receive a once‑weekly injection of Eloralintide (code name LY3841136), a medication designed to help lower body weight and improve blood‑sugar control. The injection is given under the skin (subcutaneous), which means the medicine is placed just below the surface of the skin.

The aim of the trial is to determine whether the medication can produce greater reductions in body weight and better control of blood sugar compared with a placebo. Participants are randomly assigned to receive either the active medication or the placebo, and neither the participants nor the study staff know which treatment is given. Over the course of the study, individuals will attend regular visits where simple measurements such as weight and a blood test called Hemoglobin A1c (which reflects average blood‑sugar levels over the past few months) are taken, and safety checks are performed. The study lasts for several months, during which the weekly injections continue and data are collected to assess how the medication works and whether it is safe.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit

    After joining the study, you will attend a baseline visit where your weight, blood sugar level (measured as hemoglobin A1c or HbA1c), and other health information are recorded.

    These measurements create the reference point for evaluating changes during the trial.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either eloralintide or a matching placebo. The assignment is double‑blind, meaning you and the study staff will not know which product you receive.

  3. Step 3

    Weekly Injection

    You will receive a subcutaneous (under the skin) injection of the study medication once each week.

    The injection is provided in a pre‑filled syringe and contains a fixed dose of eloralintide (or placebo) as defined by the study protocol.

    Weekly injections continue for the entire study period, which may last up to the estimated end date of April 5 2029.

  4. Step 4

    Ongoing Study Visits

    At scheduled visits throughout the trial, you will have your weight and HbA1c measured again and will be asked about any side effects.

    These visits allow the study team to monitor safety and to track the effectiveness of the treatment.

  5. Step 5

    End‑of‑Study Visit

    At the final visit, all measurements taken at baseline are repeated, and you will complete the study questionnaire.

    The data collected will be used to determine whether eloralintide changed body weight and blood sugar compared with placebo.

Who can join the trial?

8 criteria

  • Must have type 2 diabetes, a condition where the body does not use insulin properly.
  • Must have a blood test result called HbA1c between 6.5% and 9.5%, which shows average blood sugar control over the past few months.
  • Must be taking a steady dose of at least 1 and no more than 4 medicines that lower blood sugar (antihyperglycemic therapies) without any change for at least 90 days before the screening visit.
  • Must have an increased chance of having heart‑related problems (cardiovascular events) such as heart attack or stroke.
  • Must have a body mass index (BMI) of 25 or higher, where BMI is a measure that compares weight to height.
  • Must have had a stable body weight, meaning weight did not change more than 5% in the 90 days before screening.
  • Must have tried at least one diet plan to lose weight on your own that did not work.
  • Both men and women are allowed to take part in the study.

Who cannot join the trial?

6 criteria

  • You cannot take part if you have already had, or plan to have, weight‑loss surgery (such as bariatric surgery). Cosmetic procedures like liposuction (fat removal with suction), cryolipolysis (freezing fat), or abdominoplasty (“tummy tuck”) are only allowed if they were done more than one year before screening.
  • You cannot take part if you have had, or plan to have, an endoscopic procedure (using a thin tube with a camera) or a device‑based therapy for obesity, unless any device was removed more than six months before screening.
  • You cannot take part if you have type 1 diabetes (a condition where the body does not produce insulin).
  • You cannot take part if you have a history or diagnosis of very severe heart failure classified as New York Heart Association Class IV (meaning symptoms are present even at rest) or any other form of congestive heart failure (the heart cannot pump blood effectively).
  • You cannot take part if, in the 60 days before screening, you have experienced any of the following serious heart or blood‑vessel events: a heart attack (acute myocardial infarction), a stroke, hospitalization for heart failure, or a procedure to reopen blocked arteries (such as coronary, peripheral, or carotid revascularization).
  • You cannot take part if, in the 90 days before screening, you have been treated with both a sulfonylurea (a diabetes pill that makes the pancreas release more insulin) and insulin together.
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Investigated drugs

Eloralintide is an experimental medicine that is being studied to help adults who are overweight or have obesity, type 2 diabetes, and a higher risk of heart problems. It is given by a small injection under the skin using a pre‑filled syringe. In the trial, participants receive this medication once a week to see if it can lower body weight and improve blood sugar control compared with a placebo.

What is already known about the treatment

  • Eloralintide

    Eloralintide is supplied as a clear solution for injection in a pre‑filled syringe and is given under the skin (subcutaneous use) once a week. It is an investigational drug currently being studied in Phase 3 trials and is not yet approved for general medical use. The medication is being tested for weight loss, blood‑sugar control in type 2 diabetes, and reduction of heart‑related risk in people who are overweight or obese. At the molecular level it works by activating the body’s GLP‑1 receptors, which helps lower appetite and improve how the body handles glucose, and it is classified as a peptide GLP‑1 receptor agonist.

  • Placebo to match LY

    The placebo is a matching solution that contains no active drug and is administered by the same subcutaneous injection method as Eloralintide. It is used in clinical trials to serve as a control and has no therapeutic effect on weight, blood sugar, or heart risk. This inert preparation helps researchers compare the real effects of Eloralintide against a neutral baseline. It is classified simply as a placebo with no pharmacological activity.

Investigated diseases

  • Cardiovascular disease

    A condition affecting the heart and blood vessels, often caused by the buildup of fatty deposits in arterial walls. Over time these deposits can make the arteries narrower, reducing blood flow. The reduced flow may lead to chest discomfort or reduced exercise tolerance. The disease can progress silently for many years before symptoms appear. Lifestyle factors such as diet and activity level influence its development.

  • Type 2 diabetes mellitus

    A metabolic disorder characterized by high blood sugar due to the body’s reduced response to insulin. Initially the pancreas produces more insulin to compensate, but over time it may struggle to keep up. Blood sugar levels gradually rise, affecting many body systems. The condition often develops slowly and may be unnoticed for months or years. Ongoing excess weight can accelerate its progression.

  • Overweight

    A state in which a person carries more body weight than is considered healthy for their height. It usually results from an energy imbalance where calorie intake exceeds expenditure. If the excess weight is not addressed, it can increase gradually over time. Small, consistent weight gains can lead to a higher classification of weight status. Changes in diet and activity level influence its trajectory.

  • Obesity

    A more severe form of excess body weight, defined by a high amount of body fat relative to height. It often develops when excess calories are stored continuously, leading to gradual accumulation of fat. The condition can become more pronounced if lifestyle habits remain unchanged. As body fat increases, it can be harder to lose without targeted interventions. Ongoing patterns of overeating and low physical activity typically drive its progression.

Trial detailsLast updated 17 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525919-14-00Protocol codeJ3R-MC-YDASEstimated enrolment2 485 patientsSponsorEli Lilly & Co.

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