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A study to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight and type 2 diabetes

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What is this trial about?

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

This study is being conducted to evaluate the effectiveness and safety of a medication called Eloralintide, also known as LY3841136. The research focuses on individuals living with Obesity, which is a condition characterized by having excessive body fat, or being Overweight. Additionally, the study includes people who have Type 2 Diabetes, a chronic condition that affects how the body processes blood sugar. Eloralintide is an investigational treatment that will be administered via subcutaneous use, which means it is injected into the fatty tissue just under the skin.

The purpose of the study is to determine if Eloralintide is more effective than a placebo at helping to change body weight. During the study, participants will be assigned to receive either the active medication or a placebo once every week. The process is double-blind, meaning that neither the participants nor the researchers know who is receiving the actual drug or the inactive substance until the study is complete. Participants will be monitored over a period of time to observe changes in weight and to ensure safety.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and medication administration

    You will receive either eloralintide or a placebo, which is an inactive substance that looks like the medicine. the administration of the eloralintide or placebo is performed through subcutaneous use, which means the injection is given into the fatty tissue just under the skin using a pre-filled syringe.

    The medication is administered once weekly.

    The total duration of the medication administration phase is up to 64 weeks.

  2. Step 2

    Weight monitoring

    The percent change in body weight will be measured at the baseline, which is the starting point, and again at week 64 to evaluate the effect of the treatment.

Who can join the trial?

6 criteria

  • You must have type 2 diabetes, which is a condition where your body has trouble managing blood sugar levels.
  • You must be taking a stable treatment for type 2 diabetes, meaning your current medication or routine for managing your blood sugar has not changed recently.
  • Your BMI (Body Mass Index, a calculation used to see if your weight is healthy for your height) must be 27 kg/m2 or higher.
  • Your body weight must be stable, meaning your weight has not changed by more than 5% in the 90 days before starting the study.
  • Both men and women are eligible to participate.
  • Participants must be within the specific age ranges defined for this study.

Who cannot join the trial?

5 criteria

  • You must not have had or be planning to have surgery, an endoscopic procedure (a medical test where a doctor uses a thin tube with a camera to look inside your body), or device-based therapy (using a medical tool or implant to help you lose weight).
  • You cannot have type 1 diabetes, which is a chronic condition where the body does not produce the hormone needed to control blood sugar.
  • You must not have used certain blood sugar medications within the last 90 days.
  • You cannot have experienced a serious heart condition within the last 90 days.
  • You must not have taken any medications or alternative remedies (such as herbal supplements) used for weight loss within the last 90 days.
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Investigated drugs

Eloralintide is a medication given as an injection under the skin once a week. It is being studied to see how well it helps adults who are overweight, have obesity, or have type 2 diabetes to lose body weight.

What is already known about the treatment

  • Eloralintide

    This medication is provided as a solution for injection in a pre-filled syringe and is administered once weekly through a small needle under the skin. Currently being studied in late-stage clinical trials, it is being investigated as a treatment to help adults manage obesity or being overweight. It works by mimicking a natural hormone in the body to help regulate appetite and metabolism at a cellular level. This drug is classified as a metabolic hormone analog designed to promote weight loss.

  • Placebo to match ly

    This is an inactive substance administered via a subcutaneous injection to match the appearance and method of the study medication. It contains no active medicinal ingredients and is used in clinical trials to provide a baseline for comparison against the test drug. Because it has no biological effect, it is not used for treating any medical conditions. In pharmacological terms, it serves as a control tool to ensure the accuracy of the study results.

Investigated diseases

  • Obesity

    This is a condition where a person has accumulated an excessive amount of body fat. It occurs when energy intake from food exceeds the energy the body uses. Over time, the body stores this extra energy as fat tissue. The condition can affect various parts of the body and may involve a high body mass index. It typically progresses as weight continues to increase if energy balance is not maintained.

  • Overweight

    This condition is characterized by having more body weight than is considered healthy for a certain height. It often serves as a precursor to other metabolic issues. The condition occurs when an individual's energy intake is consistently higher than their energy expenditure. As the imbalance continues, the amount of body fat increases. It is often measured using body mass index scales to determine the level of excess weight.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523658-15-00Protocol codeJ3R-MC-YDAFEstimated enrolment1 035 patientsSponsorEli Lilly & Co.

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