Recruiting

A Phase III Study of Elecoglipron Compared with Semaglutide for Adults with Type 2 Diabetes Mellitus

Verified siteRegistered drugNo placebo

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What is this trial about?

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

The study involves adults who have type 2 diabetes mellitus, a condition where the body does not use insulin properly, leading to high blood sugar. Participants will receive either the experimental tablet elecoglipron or the already approved oral medication semaglutide, both taken by mouth. The goal is to see how well each medicine controls blood sugar and affects body weight.

The purpose of the study is to compare the effectiveness of the two drugs for lowering blood sugar levels, measured by HbA1c, a lab test that shows average blood sugar over the past few months. Adults will be assigned to one of the two treatment groups and will take the assigned tablet each day for about one year. During this time, they will have regular clinic visits for simple checks such as blood draws and weight measurements, allowing researchers to track changes in blood sugar control and weight without any invasive procedures.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After joining the study you will be randomly assigned to receive either the test medication elecoglipron or the comparator medication semaglutide (brand name rybelsus). the assignment is made by the study team and you will not choose the group.
Step 2
Baseline assessments
Before starting any medication you will have a series of baseline measurements. these include a blood test to determine your hbA1c level (a measure of average blood sugar), a measurement of your body weight, and a review of your medical history related to type 2 diabetes mellitus.
Step 3
Start of study medication
Once randomization is complete you will begin taking the assigned tablet each day. the comparator tablets contain semaglutide and are available in strengths of 1.5 mg, 4 mg, and 9 mg; the exact dose you receive will follow the study dosing schedule. the test tablets contain elecoglipron; the specific dose is listed as 00 mg in the study documentation and will be administered as directed by the study protocol. all tablets are taken by mouth.
Step 4
Regular monitoring visits
Throughout the 52‑week treatment period you will attend scheduled visits to check your safety and how well the medication is working. during each visit the study staff will repeat the hbA1c test, measure your body weight, and ask about any side effects or other health changes.
Step 5
Mid‑study assessments
At the middle of the study (around week 26) additional assessments may be performed to further evaluate blood sugar control and weight changes. these assessments follow the same procedures as the baseline and regular visits.
Step 6
Final assessment at week 52
At the end of week 52 you will undergo the final set of measurements. this includes a blood test for hbA1c, a measurement of body weight, and a summary of any adverse events experienced during the study. the results will be used to determine the effectiveness of the study medication compared with semaglutide.
Step 7
Study completion
After the week‑52 visit you will stop taking the study medication. the study team will provide instructions for any follow‑up care and will inform you about the overall study findings when they become available.

Who can join the trial?

6 criteria

Be diagnosed with type 2 diabetes mellitus (a condition that raises blood sugar) for at least 90 days before the screening visit.
Have diabetes that is not well controlled by diet, exercise, or up to two oral medicines that lower blood sugar.
Have a blood test called HbA1c that shows a level of 7% or higher but not more than 10.5% (this test measures average blood sugar over the past 2‑3 months).
Have a higher chance of heart problems, defined as having at least one of the following: proven coronary heart disease (narrowed heart arteries), peripheral arterial disease (narrowed arteries in the legs), ischemic cerebrovascular disease (reduced blood flow to the brain), or heart failure classified as NYHA class II‑III (moderate symptoms). Alternatively, having two or more risk factors for heart disease also qualifies.
Have a body mass index (BMI)
Have a stable body weight (no major weight loss or gain) for at least 90 days before screening, as reported by yourself or shown in medical records.

Who cannot join the trial?
7 criteria

Having type 1 diabetes mellitus, secondary forms of diabetes (including those present from birth), or a past episode of diabetic ketoacidosis (a dangerous condition where blood sugar is very high and creates acid) or hyperosmolar coma (extremely high blood sugar leading to loss of consciousness).
Currently receiving or planning to receive treatment for diabetic retinopathy (damage to the eye’s blood vessels caused by diabetes) or macular edema (swelling in the central part of the retina).
Having had more than one episode of severe hypoglycemia (dangerously low blood sugar) in the 180 days before screening, or a history of hypoglycemia unawareness (not feeling the warning signs of low blood sugar) or poor recognition of low‑sugar symptoms.
Having a clinically important condition that affects the upper gastrointestinal (GI) tract (the stomach and upper intestine), or regularly using any medication that changes gastric motility (how the stomach moves food) or gastric emptying (how quickly the stomach empties its contents).
Having a history of acute (sudden) or chronic (long‑term) pancreatitis (inflammation of the pancreas).
Having severe congestive heart failure classified as NYHA class IV (the most advanced stage where symptoms occur even at rest).
Having a personal or family history of medullary thyroid cancer (a specific type of thyroid cancer) or multiple endocrine neoplasia type 2 (an inherited condition that causes tumors in several hormone‑producing glands).

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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD
Verified
Sofia, Bulgaria
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Responsive
Bad Oeynhausen, Germany
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy
Trial locations
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Investigated drugs

Semaglutide (Rybelsus)
is a medication taken by mouth that is already approved for treating type 2 diabetes. In this study it is used as the standard treatment, or “comparator,” so researchers can see how well the new drug works compared to a medicine that doctors already know is effective. Participants will take semaglutide tablets during the trial, and the researchers will measure how it controls blood sugar and any side effects.
Elecoglipron
is the experimental drug being tested in this trial. It is also taken by mouth as a film‑coated tablet. The study is looking at whether elecoglipron can lower blood sugar, be safe to use, and be tolerated well by people with type 2 diabetes. Participants receiving elecoglipron will be compared to those taking the standard semaglutide tablets to see if the new drug works better, the same, or worse.

Azd5004
Semaglutide

What is already known about the treatment

Semaglutide
This medication is taken as an oral tablet taken by mouth once daily. It is an approved drug widely used for treating type 2 diabetes and is listed in many medical guidelines and research papers. It works by activating a hormone receptor that increases insulin release after meals and slows the emptying of the stomach, which together lower blood sugar. It belongs to the class of glucagon‑like peptide‑1 (GLP‑1) receptor agonists, a type of antidiabetic medicine.
Elecoglipron
This experimental drug is given as a film‑coated tablet taken orally. It is still under clinical investigation and is not yet approved for regular medical use, but it is being studied for type 2 diabetes treatment. It appears to act on the same hormone pathway as GLP‑1, helping the body release more insulin after eating and reducing appetite, which can improve blood‑sugar control. It is classified as a novel GLP‑1 receptor agonist being developed for diabetes therapy.

Investigated diseases

type 2 diabetes mellitus - Type 2 diabetes mellitus is a chronic condition where the body does not use insulin properly, leading to high blood sugar. Over time, the pancreas may produce less insulin, causing glucose levels to rise further. The condition often develops slowly and may start with mild symptoms such as increased thirst and frequent urination. As it progresses, blood sugar may remain elevated between meals and after fasting. The ongoing excess sugar can affect many organs and may lead to changes in vision, nerve function, and circulation.