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A study to assess the effect of elecoglipron alone and in combination with dapagliflozin on blood sugar control in adults with Type 2 diabetes

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What is this trial about?

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

The condition being studied is type 2 diabetes mellitus, a disease where the body cannot keep blood sugar at normal levels. The trial tests an experimental pill called elecoglipron taken alone, a known medicine dapagliflozin (brand name Forxiga) taken alone, and the two together, while some participants receive a placebo tablet that looks the same but contains no active drug. The purpose of the study is to find out whether the combination of elecoglipron and dapagliflozin improves blood‑sugar control better than dapagliflozin alone.

Participants will take a daily film‑coated tablet for about 40 weeks and will attend regular clinic visits where blood samples are taken to measure HbA1c (a test that shows average blood sugar over the past few months), Fasting plasma glucose (blood sugar after not eating), and will record their own readings using self‑monitoring of blood glucose. Weight, systolic and diastolic blood pressure will also be checked. The study follows a double‑blind design, meaning neither the participants nor the researchers know which pill is being taken until the study ends.

The research process

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

  1. Step 1

    Assignment to treatment group

    After enrollment, you will be placed into one of four groups using a randomized process, meaning the assignment is decided by a computer and not by the study staff.

    The study is double‑blind, so you and the study staff will not know which medication you receive.

  2. Step 2

    Receiving study medication

    You will receive tablets that are taken by mouth. the possible tablets are elecoglipron, dapagliflozin, a combination of both, or matching placebo tablets.

    Each tablet is film‑coated and the exact dose is written on the label; you will be instructed to take the tablets exactly as shown.

  3. Step 3

    Starting daily medication

    You will take the assigned tablet(s) once each day, usually in the morning, for a total period of 40 weeks.

    The medication is taken with water and can be taken with or without food, unless instructed otherwise.

  4. Step 4

    Clinic visits and assessments

    Baseline visit: at the first visit after starting medication, blood samples will be taken to measure HbA1c (average blood sugar over the past 2‑3 months), fasting plasma glucose (FPG) and other safety labs.

    Follow‑up visits: you will return to the clinic approximately every 4 to 12 weeks (e.g., weeks 4, 12, 24, and 40). during each visit, weight, blood pressure (systolic SBP and diastolic DBP) and blood samples will be collected.

    The final visit at week 40 will include the same measurements to determine the effect of the medication.

  5. Step 5

    Self‑monitoring of blood glucose

    You will be asked to measure your blood sugar using a finger‑stick device seven times a day (called a 7‑point SMBG profile) on specified days.

    The results are recorded in a diary or entered into an electronic device as instructed.

  6. Step 6

    Use of rescue medication if needed

    If your blood sugar becomes too high during the study, your doctor may start a rescue medication. the time when rescue medication is started will be recorded.

  7. Step 7

    Study completion

    At the end of week 40, you will have a final assessment and will stop taking the study tablets.

    The study team will collect all remaining medication and review your health data to evaluate the results.

Who can join the trial?

5 criteria

  • Have been diagnosed with type 2 diabetes mellitus at least 90 days before the screening visit.
  • Have type 2 diabetes that is not well controlled by diet and exercise alone, or are only taking metformin (a common diabetes medicine), and are not using any other blood‑sugar medicines.
  • Have a blood test result called HbA1c that is 7% or higher but not more than 10.5% (this test shows average blood sugar over the past 2–3 months).
  • Have a body mass index (BMI) of 23 or higher at the screening visit (BMI is a number that relates weight to height).
  • Have had a stable body weight for at least 90 days before screening, meaning your weight has not changed much during that time.

Who cannot join the trial?

7 criteria

  • Having type 1 diabetes (or other rare forms of diabetes that are not type 2), or a past episode of ketoacidosis (a dangerous buildup of acids in the blood) or hyperosmolar coma (a severe, high‑blood‑sugar emergency).
  • 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 serious low‑blood‑sugar event (severe hypoglycemia) in the last 180 days, or a history of not recognizing low‑blood‑sugar symptoms (hypoglycemia unawareness).
  • Having a significant problem affecting the upper part of the digestive system (upper GI tract) or regularly taking medicines that change how the stomach moves food (gastric motility) or empties (gastric emptying).
  • Having a past episode of pancreatitis (inflammation of the pancreas), whether it was a short‑term (acute) or long‑term (chronic) condition.
  • Having very severe heart failure classified as NYHA IV (the most advanced stage where the heart cannot pump enough blood even at rest).
  • Having a personal or family history of medullary thyroid cancer (a rare thyroid tumor) or multiple endocrine neoplasia type 2 (a genetic condition that can cause tumors in several hormone‑producing glands).
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Investigated drugs

  • Elecoglipron

    is an experimental oral tablet being tested for people with type 2 diabetes. It is taken by mouth and is expected to help lower blood‑sugar levels. In this study the drug is examined both by itself and together with another diabetes medicine to see how well it works and how safe it is.

  • Dapagliflozin

    (brand name Forxiga) is an approved oral medication for type 2 diabetes. It works by helping the kidneys remove extra glucose in the urine, which can lower the amount of sugar in the blood. In this trial the drug is studied alone and in combination with Elecoglipron to compare their effects on blood‑sugar control.

What is already known about the treatment

  • Elecoglipron

    This investigational drug is taken by mouth as a film‑coated tablet. It is still under clinical study and not yet approved for regular medical use. The medicine is being tested for people with type 2 diabetes to help lower blood sugar. It works by improving the body’s response to insulin and reducing the amount of glucose made by the liver, and it is classified as an experimental oral glucose‑lowering agent.

  • Dapagliflozin

    Dapagliflozin is an oral, film‑coated tablet that is already approved and widely used in medical practice. It is prescribed for adults with type 2 diabetes to help control high blood sugar. The drug blocks a protein in the kidneys called SGLT2, which reduces glucose reabsorption and causes excess sugar to be passed out in the urine. It belongs to the pharmacologic class of SGLT2 inhibitors, a type of glucose‑lowering medication.

Investigated diseases

Type 2 diabetes mellitus - a long‑lasting condition in which the body does not use insulin effectively, leading to higher than normal blood sugar levels. It usually begins with mild elevations in glucose that may go unnoticed. Over time the body’s cells become more resistant to insulin, and the pancreas may produce less insulin. This gradual loss of control can cause the blood sugar level to rise steadily. As the disease progresses, it can affect the eyes, kidneys, nerves, and blood vessels, resulting in additional health issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523941-81-00Protocol codeD7261C00003Estimated enrolment2 000 patientsSponsorAstraZeneca AB

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