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A study to evaluate the effectiveness and safety of eloralintide in adults with obesity or overweight without 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 aims to evaluate the effectiveness and safety of a medication called Eloralintide, which is also known by the code LY3841136. The research focuses on individuals living with Obesity, a condition where excess body fat may affect health, or those who are Overweight but do not have Type 2 Diabetes, a chronic condition that affects how the body processes blood sugar.

Participants in the study will receive either the study drug or a placebo through a subcutaneous injection, which means the medicine is delivered by a needle into the fatty layer of tissue just under the skin. The medication is provided as a solution for injection in a pre-filled syringe and is intended to be used once every week. This research is designed to determine if Eloralintide can lead to a greater reduction in body weight compared to the placebo over a period of time.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
The study begins with the administration of either eloralintide or a placebo, which is an inactive substance used for comparison.
The medication, eloralintide, is provided as a solution for injection in a pre-filled syringe and is administered through subcutaneous use, which means it is injected into the fatty tissue just under the skin.
Step 2
Weekly administration
The assigned medication is administered once weekly.
Step 3
Weight monitoring
The percent change in body weight is measured from the baseline, which is the initial measurement at the start of the study, through week 64.

Who can join the trial?

5 criteria

Be a person who is overweight (weighing more than what is considered healthy for your height) or has obesity (a medical condition where excess body fat has accumulated to an extent that it may affect health).
If you are overweight, you must also have at least one of the following conditions: high blood pressure (when the force of blood against your artery walls is too high), high cholesterol (having too many fatty substances in your blood), obstructive sleep apnea (a condition where your breathing repeatedly stops and starts while you sleep), or heart disease (a general term for various conditions that affect the heart).
Have maintained a stable body weight, meaning your weight has not changed by more than 5% in the 90 days before starting the study.
Have previously reported at least one attempt to lose weight through dietary efforts (changing what you eat) that was not successful.
Be either male or female.

Who cannot join the trial?

4 criteria

You cannot participate if you have type 1 diabetes or type 2 diabetes, which are conditions where your body has trouble managing blood sugar (the amount of sugar in your blood).
You are not eligible if you have recently had or are planning to have surgery, an endoscopic procedure (a medical test where a tube with a camera is used to look inside your body), or any device-based therapy (using a medical tool or implant) to help you lose weight.
You cannot join if you have experienced a serious heart condition, such as a heart attack or irregular heartbeat, in the 90 days before your first check-up for this study.
You are excluded if you have used any medications (prescription or over-the-counter drugs) or alternative remedies (such as herbal supplements) intended to help with weight loss in the 90 days before your first check-up.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Ambenet GmbH Das Ambulante Behandlungsnetz
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Leipzig, Germany
CRS Clinical Research Services Management GmbH
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Berlin, Germany
Jessa Ziekenhuis
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Hasselt, Belgium

Trial locations

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Investigated drugs

Eloralintide is an experimental medication being tested to see if it helps adults who are overweight or have obesity lose weight. It is given as an injection under the skin once a week.

LY3841136 SODIUM

What is already known about the treatment

Eloralintide - This medication is an experimental drug provided as a solution for injection in a pre-filled syringe and is administered once a week 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 weight when they are overweight or living with obesity. It belongs to a class of drugs that work by targeting specific proteins in the body to regulate appetite and hunger signals at a molecular level.

Investigated diseases

Obesity
This condition involves an excessive accumulation of body fat that may impair health. It often occurs when there is an imbalance between the energy consumed through food and the energy used by the body. Over time, the amount of stored fat continues to increase. This process is driven by various factors including diet and physical activity levels.
Overweight
This condition refers to having a body weight that is higher than what is considered healthy for a given height. It serves as a state where the body carries more weight than is typical for an individual's frame. The condition can progress if the surplus of calories continues over a long period. It is often measured by comparing weight to height.