Elecoglipron with or without dapagliflozin in adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares elecoglipron alone and in combination with dapagliflozin to placebo in adults with type 2 diabetes not adequately controlled by lifestyle changes or current meds. Participants are randomized to receive one of four regimens: elecoglipron, elecoglipron with dapagliflozin, dapagliflozin alone, or matched placebos for both drugs. The study will assess efficacy on glycemic control and monitor safety and tolerability over a defined treatment period. Eligible participants have type 2 diabetes with HbA1c 7% to 10.5%, BMI ≥23, and stable weight, and must not have certain diabetes-related complications or recent severe hypoglycemia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
* T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
* HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
* Body mass index (BMI) of ≥ 23 kg/m2 at screening
* Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion Criteria:

* Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
* Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
* Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
* Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
* History of acute or chronic pancreatitis
* Severe congestive heart failure (New York Heart Association IV)
* History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Where it's running

• Research Site
  Kaohsiung City, Taiwan Recruiting
• Research Site
  Taichung, Taiwan Recruiting
• Research Site
  Birmingham, Alabama, United States Not yet recruiting
• Research Site
  Daphne, Alabama, United States Not yet recruiting
• Research Site
  Lomita, California, United States Not yet recruiting
• Research Site
  Los Alamitos, California, United States Not yet recruiting

+99 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

• Acupuncture plus vitamin B12 for diabetic heart nerve damage

  This study tests whether adding acupuncture to standard care and vitamin B12 can help adults with type 2 diabetes who have damaged the nerves that control the heart.

  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07907536

• Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes

  This pilot test checks if a CDS message given to clinicians can help decide whether to consider SGLT2 inhibitors for adults with type 2 diabetes who recently had acute kidney injury.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07868666

• Body composition changes after starting GLP-1 therapies in adults with obesity or type 2 diabetes

  This study will follow adults with obesity and/or type 2 diabetes who are starting or adjusting a GLP-1 receptor agonist to see how their muscle and fat change over about a year.

  Recruiting at 2 sites Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Mexico City, Mexico City and 1 other locations · NCT07835360

• Single-dose PK study of HRS-4729 in adults with and without kidney impairment

  This study tests a single dose of HRS-4729 to see how the body handles it in adults with various levels of kidney function compared with healthy adults.

  Recruiting Phase 1 Fujian Shengdi Pharmaceutical Co., Ltd. · Chengdu, Sichuan · NCT07807059

• Once-daily ASC30 to See if it helps adults with obesity or overweight and Type 2 diabetes

  This study tests three daily doses of ASC30 against placebo in adults who are overweight or obese and have Type 2 diabetes to see if it helps with weight loss and safety over time.

  Recruiting at 6 sites Phase 3 Ascletis Pharma Inc · Birmingham, Alabama and 134 other locations · NCT07743450

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.