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Phase III randomized trial of elecoglipron to assess safety and weight loss in adults with obesity or overweight, with or without type 2 diabetes

Fast replyInvestigationalNo placebo

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What is this trial about?

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

The trial examines whether the oral tablet Elecoglipron can help adults who have obesity or are overweight, with or without Type 2 Diabetes Mellitus. The goal is to see if the drug leads to greater loss of body weight compared with a dummy pill (placebo).

Participants will be randomly assigned to receive either the study drug or the dummy pill, and neither the participants nor the study staff will know which is given (double‑blind). They will take the assigned tablet once daily for about 72 weeks, while attending regular clinic visits where weight, waist size, blood pressure, and a blood test called HbA1c (which shows average blood sugar over several months) are measured. The study will track how much weight is lost and whether other health measures improve over the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and receipt of study medication
After you join the study, you will be assigned by chance to receive either elecoglipron or a matching placebo. this process is called randomization and ensures that the groups are comparable.
The medication is provided as a film‑coated tablet for oral use. each tablet contains 00 mg of the active substance (or no active substance for the placebo). the exact dose and frequency are instructed by the study staff.
Step 2
Start taking the oral tablet
You will begin taking the tablet as directed, usually once daily, and continue for the full study period of 72 weeks. the tablet is swallowed with water and should be taken at the same time each day.
The study is double‑blind, meaning you and the study staff will not know whether you are receiving elecoglipron or the placebo.
Step 3
Baseline assessment
At the first visit, measurements of your body weight, waist circumference, blood pressure, and blood tests (including hemoglobin a1c) will be taken. these values serve as the starting point for later comparison.
Step 4
Periodic safety and efficacy visits
Throughout the 72‑week period you will attend scheduled clinic visits. during each visit, the study team will check your weight, waist size, blood pressure, and may repeat blood tests to monitor safety and how the medication is working.
Any side effects you experience will be recorded and evaluated by the study physicians.
Step 5
Final assessment at week 72
At week 72, a comprehensive evaluation will be performed. the same measurements taken at baseline—body weight, waist circumference, blood pressure, and hemoglobin a1c—will be repeated.
The primary goal is to determine the percent change in body weight from the start of the study to week 72. secondary goals include absolute weight change, proportion of participants achieving 5 %, 10 % or 15 % weight loss, changes in waist size, blood pressure, and blood sugar control.
Step 6
Study completion
After the final assessment, the study medication will be discontinued and you will receive any standard follow‑up care recommended by your health provider.

Who can join the trial?

5 criteria

Be at least 18 years old and able to give legal consent.
Have a body mass index (BMI) of 30 kg/m² or higher, or a BMI between 27 and 30 kg/m² + at least one of these weight‑related health problems: high blood pressure (hypertension), slightly high blood sugar (prediabetes), abnormal blood fats (dyslipidemia), heart or blood‑vessel disease (cardiovascular disease), or breathing problems during sleep (obstructive sleep apnea).
For the second part of the study, have a BMI of 27 kg/m² or higher and have type 2 diabetes mellitus (T2DM), which means either a doctor has already diagnosed you with T2DM or a blood test shows an HbA1c level of 6.5 % or more (HbA1c measures average blood sugar over the past 2‑3 months).
Have kept your body weight fairly steady for the past 90 days, with no change greater than about 5 % up or down.
Have tried at least one diet plan on your own that did not lead to lasting weight loss.

Who cannot join the trial?

7 criteria

Having a confirmed diagnosis of type 1 diabetes or type 2 diabetes.
Having a blood test called HbA1c that is 10 % or higher (this means very high average blood sugar over the past few months).
Receiving, or expected to receive, treatment for eye problems caused by diabetes, such as diabetic retinopathy (damage to the back of the eye) or macular edema (swelling in the central part of the retina).
Having experienced more than one episode of severe low blood sugar (hypoglycemia) in the last 180 days, or having trouble recognizing the signs of low blood sugar.
Having a history of acute (sudden) or chronic (long‑lasting) pancreatitis (inflammation of the pancreas), unless it was caused by gallstones, the gallbladder has been removed, and the condition is fully resolved.
Having a personal history or a first‑degree family member (parent, sibling, or child) with medullary thyroid cancer (a rare type of thyroid tumor).
Having a personal history or a first‑degree family member with multiple endocrine neoplasia type 2 (a genetic condition that can cause tumors in several glands).

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Bad Oeynhausen, Germany
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

Elecoglipron is an oral medication that comes as a film‑coated tablet. In this study it is being tested to see if it can help adults who are obese or overweight, with or without type 2 diabetes, lose a greater percentage of body weight compared with a placebo. Participants take the tablet by mouth, and researchers will monitor how well it works and whether it is safe to use. The goal is to determine if Elecoglipron can be a useful treatment for weight management in these populations.

Azd5004

What is already known about the treatment

Elecoglipron
Elecoglipron is taken by mouth as a film‑coated tablet. It is still an investigational drug and has not been approved for general medical use, with studies published only in early clinical research. The medicine is being tested to help adults who are obese or overweight, with or without type 2 diabetes, lose body weight. It works by activating the body’s GLP‑1 receptors, which reduces appetite and slows food intake, and it belongs to the class of GLP‑1 receptor agonists used for weight management.
Placebo for Elecoglipron (AZD5004)
The placebo for Elecoglipron is an oral tablet that contains no active drug and is used only in clinical trials. It is not a marketed medication and serves as an inactive control to compare the effects of Elecoglipron. The tablet has no therapeutic purpose and does not produce any pharmacological action, making it a standard placebo used in research studies.

Investigated diseases

Obesity
A condition where excess body fat accumulates, leading to a body mass index (BMI) of 30 kg/m² or higher. It usually develops gradually as energy intake consistently exceeds energy use. Over time, the extra fat can increase in size and spread to different parts of the body. The condition can become more pronounced if eating habits and activity levels do not change. It may also be linked with other health changes such as higher blood pressure or blood sugar.
Overweight
A state in which a person’s BMI is between 25 and 29.9 kg/m², indicating more body weight than is considered ideal for health. It often appears when calorie intake is slightly higher than the calories burned. If the pattern continues, the extra weight can slowly increase and move toward obesity. It can also be associated with changes in waist size and metabolic measures.
Type 2 diabetes mellitus
A chronic condition where the body does not use insulin properly, causing blood sugar levels to rise. It usually starts with the pancreas producing enough insulin but the cells becoming less responsive. Over time, the pancreas may produce less insulin as it becomes strained. The elevated blood sugar can persist and may affect many parts of the body if the underlying problem continues. It often develops slowly and may be accompanied by weight changes.